IVD and Bioanalytics in Berlin-Brandenburg

Potentials – Profiles – Perspectives

3Contents

Contents

4 | IVD and Bioanalytics in Berlin-Brandenburg – Covering the Full Range of the Value Chain

6 | Overview Map of Regional Players Involved in IVD and Bioanalytics

8 | Committed to Improving Diagnostics and Bioanalytics – Key Areas of Research and Development

9 | Technological Advancements – Basis for Innovations 9 Different technologies, same objective – Point-of-Care testing 10 Achievingimprovedefficiency–multiparametertesting 11 Biosensors–providingbetterstabilityandsensitivity

12 | The Impact of Omics Technologies – Advancing the Development of New Diagnostics and Therapeutics

15 | Laboratory Medicine – Essential for Therapy Optimization

16 | High Quality Biobanks – Key for Biomedical Research

17 | Services – From Assay Development to Contract Manufacturing

18 | Creating Synergies – Combining Bioanalytics with Other Technologies Leads to Cross Innovation 19 OpticalTechnologies–virtuallyprovidinginsights 21 MicrosystemsTechnologyandMicroelectronics– integralpartsofminiaturizedbioanalyticaltestsystems 22 ProcessTechnologies–accompanyinglifesciencesfromR&Dtomanufacturing 23 MaterialSciences–enhancingbioanalyticsbyuseoffunctionalpolymers

24 | More Innovation through Cooperation – Networks Facilitate Collaborative Efforts

26 | Future Opportunities and Challenges – a Perspective

28 | Directory of Regional Players Involved in IVD and Bioanalytics

39 | Imprint

4 Introduction

Precise diagnoses are indispensable for targeted therapies.Inthehugefieldofdiagnosticprocedures,invitrodiagnosticsplayaveryprominentroletofacili-tatedecisionmakingofphysiciansofallspecialties.

Basicresearchontheidentificationofbiomarkersasindi-cators for biological and pathogenic processes – predomi-nantlyconductedatthenumerousregionaluniversitiesandacademic institutions in Berlin and Brandenburg – oftenmarks the start in the development of innovative diagnos-tics.Furtherstepsinvolvealsocompanyengagementandinclude applied and translational research, technologydevelopment,clinicalvalidation,scale-upforindustrialpro-ductionandfinallythecommercializationofaproductreadyfor the market. The region is well-positioned to cover the entirevaluechain!

Due to the rapid progress and increasing use ofhigh-throughput technologies inareassuchasgenomics,proteomics, metabolomics and glycomics, an increasing

numberofbiomarkersareavailableforuseinnewinvitrodiagnostics techniques. In addition to its use tomake orconfirmadiagnosis,novelbiomarkersallowforthestratifi-cationofpatientsorpatientgroupsanddiseasescanalsobetter be divided into sub-types. Both approaches con-tributetoamoretargetedtreatment intermsofpersonal-izedmedicine.Theadvancingdevelopmentofcompaniondiagnosticstomonitortherapysuccessisanotherpromis-ing strategy to improve patient outcome and to enhancehealthcareefficiency.

One of the most representative examples of translational medicine in the capital region is the Berlin Institute ofHealth(BIH),whichconnectsmedicalresearchbyCharité–UniversitätsmedizinBerlin andbasic research from theMax Delbrück Center for Molecular Medicine (MDC) tostrengthen translational research. By doing so, the sys-tems medicine approach of the BIH combines biomarker research at a genomic and proteomic level with clinical patientdataforspecificindicationareas.

DuringthelasttwentyyearstheBerlin-Brandenburgregionhasdevelopedtowardsahealthcareloca-tionofEurope-wideimportance.Itsmajorstrengthsareauniqueresearchlandscapeandacomplexnetworkofcompaniesand institutionsacrossalldisciplines.Berlin-Brandenburghasextraordinaryexpertiseintheareasofinvitrodiagnosticsandbioanalytics.About100companiesandmorethan20researchfacilitiesarecommittedtoIVDandcovertheentirevaluechain–frombiomarkeridenti-ficationtoclinicalvalidation,fromdevelopingcutting-edgeplatformtechnologiesuptotheproductionof innovative diagnostic tools.

IVD and Bioanalytics in Berlin-Brandenburg – Covering the Full Range of the Value Chain

5Introduction

Many modern diagnostic and bioanalytical techniquesinvolve in-depthknowledgeofdisciplinesbeyond lifesci-encesandintegratingcrosscuttingtechnologieslikeinfor-matics, optical technologies, microsystems technology,microelectronics,materialsciences,nanotechnology,pro-cesstechnologiesandengineeringsciencesismandatory.Duetotheexcellentresearchenvironment,playersinBer-linandBrandenburgareintheprivilegedsituationthattheyfindextraordinaryexpertiseinthesefieldsallaroundthem.Shortdistances,variouseventsandnetworkingactivitiesfacilitate exchange and collaborative efforts which often resultincrossinnovation.

Another asset of the region is the extensive clinic landscape –includingCharité–UniversitätsmedizinBerlin,oneofthelargest university hospitals in Europe, and Vivantes, thelargestmunicipalhospitalgroupinGermany–andaccesstolargepatientpopulationsforclinicaltrialsandvalidationstudies.Accordingtoarecentevaluationofthepublicstudyregistry "clinicaltrials.gov" by the GermanAssociation ofResearch-based Pharmaceutical Companies (vfa), Ger-manyisNo.2worldwideinclinicaltrials.Nationwide,532trialsstartedin2016andwith201studiesinBerlin-basedmedicalfacilities,BerlinleadstheGermanranking.

More than 100 companies – a considerable number ofthem spin-offs from regional universities and researchinstitutions – benefit from this outstanding environmentand have established successful businesses in the IVDandbioanalytics field.Besidesproviding dedicatedprod-uctsandservices theyhavedevelopedplatform technol-ogies toenable furtherprogress indiagnosticsand ther-apy.Epigenomic’sproprietaryDNAmethylationbiomarkertechnology to advance cancer diagnosis, Metanomics

Healths’ metabolite profiling technology platform, Alacris’ModCell™ technology, a systems medicine modelingtool that offers individualized drug response predictions, SCIENION’ssciFLEXARRAYERdispensingtechnologyfornon-contact ultra-low volume liquid handling, Medipan’sfully automated system for standardized immunofluores-cenceimaginganddataprocessingAKLIDES®, or Capro-tec’s Capture Compound Mass Spectrometry (CCMS)technologyfor the investigationofsmallmoleculeproteininteractions are just a few examples to demonstrate thebroad rangeofapplications.Furtherexamplesof currentdevelopments from both, industry and academia, will bepresented in greater detail on the following pages.

Thedevelopmentoftheregionintoanumberonelocationfor invitrodiagnosticsandbioanalyticshasbeencontin-uously accompanied by a strongpolitical commitment toenhanceandsupporttechnologytransferandgrowthareasof healthcare – as e.g. reflected in the joint innovationstrategyofBerlinandBrandenburg(MasterplanGesund-heitsregion Berlin-Brandenburg). Various initiatives andnetworks have been established to foster the exchange of expertise and collaborative efforts. The Diagnostik Ber-lin-Brandenburge.V.networkmayserveasonesuccessfulexample.Theassociation–foundedin2007–hasbroughttogether innovative companies, renowned international researchinstitutions,laboratoriesandexpertpartnersfromBerlin-Brandenburgandsixother federal states to jointlydevelop,manufacture,andsellinvitrodiagnosticproducts.The network combines the diverse areas of expertise of itsover65members, covering theentire valuechain forin vitro diagnostics.

6 OverviewMapofRegionalPlayersInvolvedinIVDandBioanalytics

Overview Map of Regional Players Involved in IVD and Bioanalytics

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co:bios Technologiezentrum

GO:INGolm

Innovation Center

Biotech Campus Potsdam

Luckenwalde Biotechnology Park

berlinbiotechpark

Campus Berlin-Buch

Wuhlheide Innovation Park

Science and Technology Park Berlin-Adlershof

Life Sciences Companies

Research Institutions 1 Berlin Institute of Health 2 Experimental and Clinical Research Center (ECRC) 3 Fraunhofer Institute for Applied Polymer Research (IAP) 4 Fraunhofer Institute for Cell Therapy and Immunology (IZI) - Bioanalytics and Bioprocesses 5 German Heart Center Berlin (DHZB) 6 German Institute of Human Nutrition (DIfE) 7 German Rheumatism Research Centre Berlin (DRFZ) 8 Hasso Plattner Institute for Software Systems Engineering 9 IHP Innovations for High Performance Microelectronics 10 Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) 11 Max Delbrück Center for Molecular Medicine (MDC) 12 Max Planck Institute for Infection Biology13 Max Planck Institute of Colloids and Interfaces14 Max Planck Institute for Molecular Genetics

Federal Institutions 1 Federal Institute for Materials Research and Testing (BAM) 2 Federal Institute for Risk Assessment (BfR) 3 National Metrology Institute of Germany (PTB) 4 Robert Koch Institute (RKI)

Universities 1 Brandenburg University of Technology Cottbus - Senftenberg 2 Brandenburg University of Applied Sciences 3 Brandenburg Medical School Theodor Fontane 4 Charité - Universitätsmedizin Berlin 5 Freie Universität Berlin 6 Humboldt-Universität zu Berlin 7 Technical University of Applied Sciences Wildau 8 Technische Universität Berlin 9 University of Potsdam

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7OverviewMapofRegionalPlayersInvolvedinIVDandBioanalytics

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co:bios Technologiezentrum

GO:INGolm

Innovation Center

Biotech Campus Potsdam

Luckenwalde Biotechnology Park

berlinbiotechpark

Campus Berlin-Buch

Wuhlheide Innovation Park

Science and Technology Park Berlin-Adlershof

Life Sciences Companies

Research Institutions 1 Berlin Institute of Health 2 Experimental and Clinical Research Center (ECRC) 3 Fraunhofer Institute for Applied Polymer Research (IAP) 4 Fraunhofer Institute for Cell Therapy and Immunology (IZI) - Bioanalytics and Bioprocesses 5 German Heart Center Berlin (DHZB) 6 German Institute of Human Nutrition (DIfE) 7 German Rheumatism Research Centre Berlin (DRFZ) 8 Hasso Plattner Institute for Software Systems Engineering 9 IHP Innovations for High Performance Microelectronics 10 Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) 11 Max Delbrück Center for Molecular Medicine (MDC) 12 Max Planck Institute for Infection Biology13 Max Planck Institute of Colloids and Interfaces14 Max Planck Institute for Molecular Genetics

Federal Institutions 1 Federal Institute for Materials Research and Testing (BAM) 2 Federal Institute for Risk Assessment (BfR) 3 National Metrology Institute of Germany (PTB) 4 Robert Koch Institute (RKI)

Universities 1 Brandenburg University of Technology Cottbus - Senftenberg 2 Brandenburg University of Applied Sciences 3 Brandenburg Medical School Theodor Fontane 4 Charité - Universitätsmedizin Berlin 5 Freie Universität Berlin 6 Humboldt-Universität zu Berlin 7 Technical University of Applied Sciences Wildau 8 Technische Universität Berlin 9 University of Potsdam

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8 CommittedtoImprovingDiagnosticsandBioanalytics–KeyAreasofResearchandDevelopment

The regional involvement in IVD & bioanalytics includesvarious approaches. Individual players in this huge fieldaretacklingcurrentchallengesfromverydifferentstartingpoints.

Toprovideagroupingofapplicationareas, inthisspecialissueaclassificationhasbeenappliedthatclusterstopicsaroundbiomarkers and the impact of Omics, technolo-gy-based innovations and servicesinthefieldofIVD&bioanalytics.However,innovativestrategiesusuallyinvolvetheexpertiseof quitea fewdisciplinesand therefore theactivitiesofregionalplayersoftencanbeallocatedtomorethanoneofthesesubsections.

Thedevelopmentofinvitrodiagnosticsrequiresvalidatedbiomarkers as a prerequisite.The impact ofOmics tech-nologies,suchasgenomics,proteomics,metabolomicsorglycomicsfortheidentificationofnewbiomarkershasbeenimpressively demonstrated in recent decades. Furtherprogress has been achieved by advanced high through-putscreening technologies.Major regionalplayers in thisfieldincludeCharité–UniversitätsmedizinBerlin,Institute

ofLaboratoryMedicine,ClinicalChemistryandPathobio-chemistry;Leibniz-ForschungsinstitutfürMolekularePhar-makologie;theMedLaboftheResearchCampusMODAL(Mathematical Optimization and DataAnalysis Laborato-ries),aplatformofZuse InstituteBerlin,FreieUniversitätBerlin together with 12 participating companies as well as several companies such asAlacris Theranostics GmbH,Metanomics Health GmbH, Metabolomic DiscoveriesGmbHandATLASBiolabsGmbH.

PlayersinBerlinandBrandenburgaredevelopingtechnol-ogy-based innovations to provide novel in vitro diagnos-tics and other diagnostic methods. Universities, research institutes and companies have a strong position in latestdevelopmentsinthefieldofPoint-of-Caretesting,Lab-on-aChip and Organ-on-a-Chip technologies, biosensors and multiparameteranalytics.

These predominantly chip-based diagnostics are accom-panied by other modern analytical technologies such asmassspectrometryand itsdistinctiveadvancements,e.g.CyTOF (CytometrybyTimeofFlight) orCCMS (CaptureCompound Mass Spectrometry) the latter having beendevelopedbyCaprotecbioanalyticsGmbH.

Withregardtoinvitrodiagnosticsandbioanalyticsservices,laboratorymedicineplaysasignificantroleandtheInstituteofLaboratoryMedicine,ClinicalChemistryandPathobio-chemistry of Charité – Universitätsmedizin Berlin is thekey provider in this field. Berlin is also an important siteforbiobanks–onanationalandEuropeanlevel.BiobanksliketheCentralandInterdisciplinaryBiobankoftheCharité(ZeBanC)collectawiderangeofpatientsamples,supportresearchprojectswithsamplesanddataandoffervariousservicesfortheprocessingandanalysisofbiomaterials.

Companies and research institutes in Berlin and Bran-denburgofferagreatvarietyofserviceswhichrangefrombiomarkeridentification,nextgenerationsequencing,overassaydevelopmenttoISO-certifiedcontractmanufacturingof IVD tests.

Committed to Improving Diagnostics and Bioanalytics – Key Areas of Research and Development

Researchanddevelopment in IVDandbioanalytics coverabroadspectrumofapplications.Aca-demiaandindustryinBerlinandBrandenburgdevelopstate-of-the-artsolutionsfornextgenerationinvitrodiagnosticsandbioanalyticsandhaveaproventrackrecordofinnovativeproductsresultingfromexcellentandoftenjointlyconductedresearchefforts.

9Technological Advancements – Basis for Innovations

Technological Advancements – Basis for Innovations

Technology-based innovations advance the development of next generation in vitro diagnostics.These innovations lead to the implementationofnewdiagnostic features,more reliableand rapidresults,on-sitetesting,andwillenableimprovedpersonalizedmedicineapproaches.Currenttrendsinminiaturization,automationandmulti-parametertestingallowforcostreductionsandwillleadtomoreefficiencyinthediagnosticlaboratoryroutine.

Different technologies, same objective – Point-of-Care testing

The most striking advantage of Point-of-Care (POC) tests isthattheyempowerphysicianstomakeimmediatedeci-sionsonpatient-focusedcarewhereverdiagnostictestingisrequired.POCtestsareoftenaccomplishedbyportablehandheld detection instruments providing rapid results.The EU-funded PoC-ID project (Platform for ultra-sen-sitive Point-of-Care diagnostics for Infectious Diseases)addresses the increasing demand for rapid and sensitive point-of-care diagnostics to reduce healthcare costs andincrease thequality of lifewitha focuson infectiousdis-eases.Auser-friendlypointofcare(PoC)platformwillbedevelopedtotargettheneedforearlyandfastdetectionofviral respiratory infections. Respiratory syncytial infection(RSV)areamajorcauseofdiseaseinchildrenbutalsoamajordiagnosticsandmanagementchallengeinthedailypractice. The PoC-ID project is coordinated by LeopoldGeorgi, Technische Universität Berlin, Research Centerfor Microperipheric Technologies. Additional Berlin-based membersoftheconsortiumareAPTARIONbiotechAGandenablingMNTGmbH.

FrankHufertandhisteamof theInstituteofMicrobiologyandVirology,BrandenburgMedicalSchoolTheodorFon-tane, focusonmoleculardiagnostics tools for faston-siteviraldetectionunderfieldconditions.Thegrouphasdevel-opedmorethan50real-timePCRassaysandmorethan30assaysbasedon isothermal recombinasepolymeraseamplification(RPA).RPArepresentsaversatilealternativetoPCRandallowsreal-timedetectionofviralandbacterialgenomeswithin10minutes.Asuitcaselabforrapidmobilegenetic detection of emerging infectious diseases (EID)wasalreadytestedinafieldtrialinAfrica.Currentresearchaddresses further applications in human and veterinarymedicine.

The development of Point-of-Care tests is also a core area of theDepartment of Biosystem Integration andProcessAutomation of the Fraunhofer Institute for Cell Therapyand Immunology -BranchBioanalyticsandBioprocessesIZI-BBinPotsdam-Golm.InthedepartmentofFrankBieran in vitro diagnostics platform has been developed which is suitable forabroad rangeofpoint-of-careapplicationsand which can be adapted to different diagnostic tests. Theuniqueplatformconsistsofa labon-a-chipcartridgethesizeofacreditcardandabasestation fordetection.Bloodorotherbiologicalliquidscanbeapplieddirectlyonto

Leopold Georgi Coordinator of PoC-ID H2020 projectTechnischeUniversitätBerlin,ResearchCenterforMicroperiphericTechnologies

“InthePoC-IDproject,13partnersfrom7Europeancountriesanddifferentfieldsofscience have joined forces to develop new micro- and nanoelectronic-based sens-ingand integrationconcepts foradvancedminiaturized invitrodiagnosticdevices.Improvedperformanceintermsofrobustness,sensitivityandselectivityisachievedby a combination of innovative nanomembrane technology, molecular engineeredcapturemoleculesand twonovelelectronicsensingconcepts.ThePoC-IDprojecttargetsthediagnosisofrespiratorysyncytialvirus infectionsandhostresponses inthepediatriccontext.Oncesuccessfullytested,theplatformtechnologycaneasilybeadaptedtoavarietyofdiagnosticorbiosensingpurposes.”©

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10 Technological Advancements – Basis for Innovations

thecartridgeandwithin10–15minutes,samplesareana-lyzedautomaticallyinthebasestation.Usingmicroarrays,multiplextestingispossiblebyemployingvariouscapturemoleculessuchasantibodies,proteins,peptides,glycans

Achieving improved efficiency – multiparam-eter testing

The advantages of multiparameter diagnostics are obvi-ous.Asingletestrunallowsforthesimultaneousanalysisofmanyparametersofagivensampleandthusprovidesmore information for a reliable diagnosis. Multiplex testssavetime,leadtoimprovedefficiencyinthediagnosticpro-cessandcanadvancepersonalizedmedicineapproaches.

At theBrandenburgUniversityofTechnology (BTU)Cott-bus-Senftenberg, research groups are developing auto-matedmultiparameter testmethods forexaminingpatientblood,serumandtissues.Onemajorgoalisthedevelop-mentoftissuesection-basedmultiplexassaysthatcanbeapplied in diagnostic laboratories or research facilities. In thegroup“FISHng-FISHfor tumorandpathogendiag-nosticwithVideoScan”ofPeterSchierackandgroupleaderJulianeSchiebel,scientistsinvestigategeneticaberrations

Peter Schierack HeadoftheDepartmentofMultiparameterDiagnostics atBrandenburgUniversityofTechnology(BTU)Cottbus-Senftenberg

“Multiparameteranalyticsinthefieldoflaboratorymedicinedealswithfast,high-pre-cision and cost-efficient characterization of patient samples. Medical doctors candeduceappropriatetherapiesforpatients.Withourultra-moderntechnicalequipmentattheBrandenburgUniversityofTechnologyCottbus-Senftenberg(BTU)werealizebasicresearchandcooperativeprojectswithregionalpartnercompanies.Ourmajorinterestfocusesonbiomoleculedetectiontechnologiesincludinghardware,softwareandassaydevelopmentandonAppliedStatisticalBioinformatics.Weeducatestu-dentsincutting-edgetopicsofcellbiology,microbiology,molecularbiologyandnano-biotechnology.”©

Multim

ediazentrumderBTU

Cottbus–S

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in tumor tissues andmicroorganisms in infected tissues.Image-based multi-fluorescence detection involves the“VideoScan”technology,whichwasjointlydevelopedwithproject partners. The platform can be used for variousassaytypesbasedoncells,microparticlesorsolutions.

The group “Image-Based Assays” aims at refining thefurtherdevelopmentofmicroparticleandmicrofluidicsys-temsforuseintemperature-controlledconditionsincludingmicroparticle-based multiplex real-time PCR and meltingcurve analysis as well as cell-based detection systems.In this project – an InnoProfileTransfer Initiative –Peter Schierackandgroup leaderStefanRödiger focuson thecombination of microparticle and cell-based detection methods enhanced with statistical bioinformatics for rou-tine diagnostics. This work is concatenated to the research within the Gesundheitscampus Brandenburg (Ministryof Science, Research and Culture Brandenburg) where

Fraunhofer Institute for Cell Therapy and Immunology, Branch Bioanalytics and Bioprocesses IZI-BB TheFraunhoferIZI-BBfocussesonthedevelopmentofplatformtechnologiesandbiotech-

nologicalapplicationsinagriculture,foodsafetyandenvironmentaltestingaswellasdrugdevelopmentanddiagnos-tics.Toprovideflexibleandeasy-tousedevicesorsolutionsthekeyaspectsofactivitiesencompasscomplexsamplepreparations,datacollection,miniaturizationandautomation.Moreover,theInstitutealsoaddressesfunctionalpro-teinproductionusinginnovativecell-freebiosynthesistechniquesanddevelopsmethodforsinglecellmanipulation.Thesitehasthestate-of-the-artinfrastructurerequiredforminiaturizingandautomatingbiologicalprocesses.Thisincludesvariousbiosensorandbiochiptechnologies,pipettingrobotsandmicroandnano-dispensers,besidesmanydifferentrapid-prototypingprocedures.

oroligonucleotides. IZI-BBofferscustomersandpartnersthetransferofexistingtests(e.g.ELISAs,DNAmicroarraysandothers)totheIVDplatform,includingoptimizationandtechnicalverificationuptoIVDapproval.

11Technological Advancements – Basis for Innovations

Biosensors – providing better stability and sensitivity

Biosensorsareanalyticaldevicesthatconvertabiologicalresponse into an electrical signal. Various types of bio-sensorshavebeendevelopedinBerlinandBrandenburg,using nucleic acids, antibodies, enzymes or receptors toanalyzeitsinteractionwithagivensample.Thesebiosen-sorscanbebasedonelectrochemical,optical,piezoelectricorthermalmechanismsofsignaltransduction.

ThehistoryofBSTBioSensorTechnologyGmbHreachesback to 1975 when a biosensor research group startedat the formerBerlinAcademyofSciences.Asearlyas in1982,thefirstbiosensorbasedbloodglucosedevicewaslaunchedontheEuropeanmarket.BSTBioSensorTech-nologyGmbHwas foundedbymembers of this group in1991andhasbecomethemarketleaderinmulti-waybio-sensors inEurope.Corecompetences include thedevel-opment,optimizationandfinalproductionofbiosensorsofdifferentgenerations(membranetype,thickfilmtype,thinfilmtype,sensorarray)aswellasthedevelopmentandpro-ductionofinstrumentsbasedonbiosensors.

The development of novel biosensors is also a core area ofresearchattheInstituteofAppliedLifeSciencesoftheTechnicalUniversityofAppliedSciencesWildau(TUASW).FredLisdatisDirectorofthisInstituteandHeadoftheBio-analysisandBiosensorsLaboratory.Heandhisgroupareworkingonseveralprojects,manyofthemincollaborationwithotherresearchinstitutionsinGermanyandabroad.HeisalsopresentlytheChairoftheBioelectrochemistryDivi-sion of the International Society of Electrochemistry withmore than 600 members worldwide.

Extensiveresearchfocusesonlight-switchablesensorsbyusingsemiconductornanoparticlesorQuantumDots–dueto theiruniquephotophysicalproperties–andcombiningthemwith thebiocatalytic featuresofenzymes.Thiskindofbiohybridsystemprovidesapromisingapproachforthedevelopment of advanced bioanalytical devices allowingmulti-analyte detection. Examples of applications includelight-directed read-out of glucose and fructose oxidationandthedetectionofenzymaticallyproducednicotinamide

adenine dinucleotide (NADH). A recent system demon-strates the feasibility to use photoactive proteins for theanalysisofenzymesubstrates.

In the direction of more applied research, collabora-tions with several companies have been established. For example, an optical test system was developed for thesemi-quantitativedeterminationofproteinconcentrationsincerebrospinalliquidswiththecompanyIn.ventDIAGNOS-TICAGmbH.Thefastandsimpledetectionsystemisbasedon gold nanoparticles and was designed for point-of-care diagnosticsinemergencymedicinebyanearlyclassifica-tionofneurologicaldiseases.

Technical University of Applied Sciences Wildau (TUASW)Institute of Applied Life Sciences

The biosciences have developed into a major eco-nomicfactorintheBerlin-Brandenburgregion.Specialregionalexpertiseliesinmoleculardiagnostics,bioanalysisandmedicaltechnology.TheTUASWhasactivelyparticipatedinthesedevelopmentsandsince2001hasnotonlysetupaninterdisciplinarycourseofstudiesinbiosystemstechnology/bioinformatics,buthasalsoestablishedresearchlaboratoriesfocusingonvarioussubjectsofbiosciences.Theinstituteispresentlycomprisedof6workinggroups.

Specialcompetencesinclude:• theproductionofbiomoleculesandbiologicalstructures• biochemicaldetectionmethodsandtheanalysisof

biologicalsystems• characterizationofsurfaceswithbiologicalcompo-

nents• thedevelopmentofhybridsystemsattheinterface

betweenbiologyandtechnology,e.g.microreac-tors,microfluidicchips,biosensors,biofuelcells,photobioelectrodes etc.

• processingandhigh-performancecomputer- assistedanalysisofbio-chemicalandbioanalyticaldata

the researchers aim to find novel digitalized diagnosticapproachesinthe"digilogproject"andtoolsforaperson-alizedmedicine as part of the project "Consequences ofage-associatedcellandorganfunction".

BothgroupsarecooperatingcloselyandareworkingwithotherregionalpartnersincludingAttomolGmbH,MedipanGmbH,PolyAnGmbHandGAGenericAssaysGmbH.

The Impact of Omics Technologies – Advancing the Development of New Diagnostics and Therapeutics

12 TheImpactofOmicsTechnologies–AdvancingtheDevelopmentofNewDiagnosticsandTherapeutics

Berlin has a longstanding reputation in genomics. HansLehrach,long-termDirectorattheMaxPlanckInstituteforMolecularGenetics,wasanearlyproponentofthehumangenomeproject.Hisscientificachievementsarenumerousand includehis involvement inseveralgenomesequenc-ingprojects,keyworkonproteinmicroarray technologiesandthedevelopmentofpersonalizedmedicineapproachesonthebasisof‘virtualpatient’models.HansLehrachhasalsobeenactivelyinvolvedinacceleratingthetranslationofscientificdiscoveriesintothedevelopmentofproductsandhas co-founded several biotechnology companies. Manyof thesecompaniesare in theBerlin-Brandenburg regionand includeScienion,AtlasBiolabs,AlacrisTheranostics,aswellastheDahlemCentreforGenomeResearchandMedical Systems Biology, a non-profit private researchorganization.

One of these companies,Alacris TheranosticsGmbH, isa systems medicine company specialized in developinginnovative approaches for cancer precision medicine and drugdevelopment.Alacris hasdeveloped theaward-win-ningModCell™technology,arevolutionarysystemsmedi-cinemodelingtoolthatoffersindividualizeddrugresponsepredictionsandfacilitatesapplicationsforthepharmaceuti-cal/biotechnologyindustry,virtualizingarangeofdevelop-mentalpipelines.Thecompanyalsooffersoneofthemostcomprehensiveprecisiononcologyanalysesoptionsonthe

Genomics, proteomics,metabolomics and glycomics have become indispensable technologies tofathomtheessenceoflifeonamolecularbasis.Combinedwithhighthroughputscreeningmethods,“Omics”researchleadstotheidentificationofvariousnewbiomarkersandinturncontributestothedevelopmentofnoveldiagnosticsandtherapeutics.

markettodaythroughitsComprehensiveMolecularTumorAnalysis (CMTA) service. Alacris has also establishedinnovativemethodologies for identifying biomarkers, withapplicationsascompaniondiagnosticsandstratificationofpatientsfortargetedclinicaltrials.Forfurtherdevelopmentand validation of its technologies, Alacris participates in a range of nationally and internationally funded researchprojects.

Leibniz-Forschungsinstitut für Molekulare Pharma- kologie (FMP)Chemical Biology Platform

FMP&MDCprovideacentralopenaccessChem-icalBiologyplatformforEU-OPENSCREEN,theChemBioNet,theBerlinInstituteofHealth(BIH),andtheHelmholtz-InitiativefürWirkstoffforschung.Theplatformsupportswithstate-of-the-artequipmentforsystematicscreeningoflargecompoundorgenome-wideRNAilibraries,andformedicinalandcomputa-tionalchemistry.ItisfundedbytheEU,theFederalMinistryofEducationandResearch(BMBF),GermanResearchFoundation(DFG)andalsojointlyfinancedbytheMaxDelbrückCenterforMolecularMedicine(MDC)andtheBerlinInstituteforHealth(BIH).

Bodo LangeCEOAlacrisTheranosticsGmbH

“Next generation sequencing is currently revolutionizing omics-driven patient diag-nosticsinoncologyaswellasothergeneticdiseases.Singlegene/genevariantbio-markerdetectionhasbeenamajor step forward inpatient stratification,but thesemarkers cannot capture the complexity of genetic alterations that determine drugresponseanddrugresistance.Recentadvancesinhighlyintegrative,systemsbiol-ogy-drivenapproachesandtheidentificationofcomplexbiomarkersbasedondeepomicsanalysesare,however,helping to identify trulypersonalized therapyoptionsandopenupnewsolutionsinprecisionmedicine.”

©AlacrisTheranosticsGmbH

13TheImpactofOmicsTechnologies–AdvancingtheDevelopmentofNewDiagnosticsandTherapeutics

Massspectrometry-basedproteomicsoffersthepossibilityofmeasuringthousandsofproteinsinasinglerunandhasfundamentally changed the way that biological systemsareanalyzed.Latestdevelopments in liquidchromatogra-phy-tandemmassspectrometry(LC-MS/MS)havereducedtheeffort and instrument timenecessary for thedetermi-nationofglobalproteomesdown toseveralhours.At theBIHCoreFacilityProteomics,scientistsemployandfurther

developallcommonlyusedapproachestoaccuratelyandprecisely quantify proteins in complex samples. For pro-teome-wide discovery applications label-free, metaboliclabelingand isobaric taggingapproachesareused,whilefortargetedselectedreactionmonitoring(SRM)andparal-lelreactionmonitoring(PRM)applicationsthegroupusessyntheticspike-inreferencepeptidesforquantification.

Collaborationswithother researchgroups spanall areasofquantitativeproteomics,fromprofilingdifferentbiologicalstatesincells,tissuesandbodyfluids,tomeasuringproteininteractionswithotherproteins,drugsandnucleicacids,todetermining the spatial information of proteins and also the identificationoftheirpost-translationalmodifications.

Metabolomicstargetstheanalysisoftheentiretyoftheinter-mediatesandproductsofmetabolismwithincells,biofluids,tissues or organisms. Metanomics Health GmbH is oneof theglobalkeyplayers inthisfield.Thecompanyhostsoneoftheworld'slargestmetaboliteprofilingfacilitieswithabroadrangeofgas-chromatographyand liquid-chroma-tographycoupledmassspectrometryinstrumentsenablingunbiasedandtargetedmetabolomics.MetanomicsHealth

14 TheImpactofOmicsTechnologies–AdvancingtheDevelopmentofNewDiagnosticsandTherapeutics

provideshighlyrobustandreproducibleanalysisofmetab-olitepathwaysand theirchanges in response todisease,pharmaceuticalintervention,andnutrition.Thecutting-edgetechnologyofthecompanyincludesstate-of-the-artstatis-tics,proprietarybioinformaticstoolsandbiomedicalexpertinterpretationofhighqualitydatasets.MetanomicsHealthprovidesuniquebiomedicaldatathatcanacceleratedrugdevelopment by reducing risk, increasing efficacy, andhelpingtoidentifytherapyresponders.

AlthoughglycomicsrepresentstheyoungestoftheOmicstechnologies,itisincreasinglygarneringtremendousinter-estbecausecarbohydratesarethemostabundantbiomol-eculesonEarthandhavemyriadof functions.BerlinandBrandenburg recognized the potential of glycosciencesearly on and regional academic institutions and compa-niescoverthewholerangeofglycosciences–frombasicresearchtoadvancedglycobiotechnologyapplications.

TheworkinggroupofVéroniqueBlanchardattheInstituteofLaboratoryMedicine,ClinicalChemistryandPathobio-chemistry,Charité–UniversitätsmedizinBerlinisaimingtosystematicallyanalyzetheglycomeinthecontextofphys-iologicalmechanisms in human health and disease. The

identification and evaluation of glycan-based biomarkersrepresents a prominent field of research in Blanchard’slab. One of the dedicated research projects – together with theDepartmentofGynecologyoftheCharité–focusesonserumglycomeprofiling to identify tumormarkers for thediagnosisofepithelialovariancancer (EOC).Blanchard’sgroupisalsoworkingtowardsthenextgenerationofstemcell markers.

DataintegrationofthesediversefieldsofOmicsresearchremainsachallenge for the future. In theMODAL(Math-ematical Optimization and Data Analysis Laboratories)researchcampus,innovativemethodsfortheextractionofinformationfromlargedatasetsandtheconstructionofreal-istic models for complex processes are being researched. MODALisaplatformforpublic-privatepartnershipforinno-vationbuiltbyZuseInstituteBerlin(ZIB)andFreieUniver-sität Berlin together with 12 participating companies. More than40researchersofthecampuswilladvancethedata-driven development of pioneering modeling, simulation,andoptimizationmethods.OneofthemostimportantgoalsoftheMedLabgroupistheintegrativeanalysisofalreadyavailable patient information with the ever-growing data pools of modern Omics experiments.

“TheMetanomicsHealthGmbHtechnologyplatform,ourscientificandclinicalexper-tise, and the innovative and stimulating environment in Berlin-Brandenburg havehelpedusestablishanoutstandingproprietaryclinicalbiomarkerprogram:weiden-tifyandvalidatesimpleandcomplexnovelmetabolicbiomarkersuptotheprototypestage,thensub-licensethesetodiagnosticpartnerswithdirectaccesstothehealth-caremarket.”

Tim Bölke ManagingDirector,MetanomicsHealthGmbH

©Metanom

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Laboratory Medicine – Essential for Therapy Optimization

15LaboratoryMedicine–EssentialforTherapyOptimization

Laboratorydiagnosticsmakesacentralcontributiontodiseasedetection,therapyoptimizationandprevention.Itisthereforeofkeyimportanceforthehealthcaresystem.Laboratorymedicineinstitu-tionsinBerlinandBrandenburgnotonlyprovidetoplaboratorydiagnosticsservicesforresidentphy-siciansandhospitalsbutareactivelyinvolvedinthedevelopmentofnewdiagnosticproducts.

About100companiesandmorethan20researchfacilitiesinBerlinandBrandenburgarecommittedto invitrodiag-nosticsandcovertheentirevaluechain–frombiomarkeridentification toclinical validation,up to theproductionofinvitrodiagnostics.Theyaredeveloping innovative tech-nologies and new biomarker strategies for medicine across the board.

One of the major players in this area is Charité – Uni-versitätsmedizin Berlin. The main research focus of theInstitute of Laboratory Medicine, Clinical Chemistry andPathobiochemistry is the investigation and utilization ofpathobiochemical mechanisms for diagnostic, prognostic andtherapeuticpurposes.Researchfieldsincludeinflam-matoryprocessesandbiochemicalsignaltransduction,theimportanceof carbohydrates,molecularoncologyaswellas developments of biomarkers.

OncologyisalsoadedicatedareaofresearchattheInsti-tuteofPathologyoftheCharité.Anumberofworkinggroupsuse different approaches to elucidate specific biomedicalaspects of oncology, e.g. the groups System Pathology,ExperimentalHematopathology,GastroenterologicPathol-ogy,TranslationalTumorResearch and the joint Labora-toryofMolecularTumorPathology.Currentresearchofthelatter focusesonsystems-oriented tumorbiology,particu-larly on signal transduction systems in cancer cells. The

objectives of research projects are aiming at a detailed understandingof theorganization, regulationandbiologi-calfeaturesofsignalingsystemsinordertointegratebasiccancerresearch,moleculartumordiagnosticsandpredic-tiveoncology.

Berlinalsohosts the largesthospital laboratory inEurope:theLaborBerlin–CharitéVivantesGmbH.Beyondprovid-ing laboratorydiagnostics forpatient careofVivantesandCharitéhospitalsatatotalof12locations,LaborBerlinofferssolutions for thediagnostics industry, forCROsaswellasfor companies from the life sciences and research facilities.

Rudolf Tauber Charité–UniversitätsmedizinBerlin,HeadofInstituteofLaboratoryMedicine, ClinicalChemistryandPathobiochemistry

“Advancesinbasicbiomedicalresearchandthedevelopmentofnewanalyticaltech-nologiesandmethodshaveledtoanextraordinaryincreaseinlaboratorydiagnosticsoverthelastdecades.Berlin-Brandenburghasdevelopedintoaninternationallysig-nificant location for research&development in laboratorydiagnosticsand forcon-ductingclinical trials.Thediversityofhospitalsaswellas theuniversity'shigh-per-formancemedicineoftheCharitéenableaccesstopatientgroupsofruralandurbanpopulationsfromdifferentethnicorigins,whichlargelycoverallmedicalquestions.”

©Charité–UniversitätsmedizinBerlin

16 HighQualityBiobanks–KeyforBiomedicalResearch

High Quality Biobanks – Key for Biomedical Research

Central and Interdisciplinary Biobank of the Charité (ZeBanC)

TheZeBanCisthejointbiomaterialbankoftheCharitéandtheBerlinInstituteofHealth.Ithasacapacityofseveralmil-lion samples,whicharemainly stored in thenewbiobankbuildingattheCampusVirchowKlinikumoftheCharité.TheZeBanC operates under certified conditions according toDINENISO9001:2015.

Inaddition to theacquisitionof awide rangeof samplesfromCharitépatients,theZeBanCisresponsibleforanum-berofnationwidestudies.ZeBanChasalreadysupportednumerous researchprojectswith samplesanddata.Fur-thermore,theZeBanCoffersvariousservicesforthepro-cessingandanalysisofbiomaterials.TheZeBanCisalsoresponsibleincooperationwiththeCharitéComprehensiveCancerCenter(CCCC)fortheacquisitionofunfixedtumortissuesamplesandcorrespondingbloodsamplesforcon-trol. Since the CCCC is responsible for comprehensive doc-umentationofrelatedpatientandmedicalrecordsinpseud-onymized form, these biomaterials and their clinical datamaybeintegratedinscientificquestionsinordertostronglyimprove translational oncological research.

German Biobank Node

TheGermanBiobankNode(GBN)isthecentralcontactandexchangefortheGermanBiobankcommunity–notonlyforresearchers, but also for politics,media, representatives ofpatients, industryandfundinginstitutions.TheGBNaimstocreate a better networking of national biobanks, to facilitate exchange of experience between biobanks and to develop standards forqualityassurance.Otheractivitiesaddresstheelaboration of an IT concept for sample and data exchange. TheGBNalsorepresentstheinterestsoftheGermanbiobankcommunityintheEuropeannetworkofbiobanks(BBMRIERIC)

National Register for Congenital Heart Defects

TheNationalRegisterforCongenitalHeartDefectsprovidesaprofessionalinfrastructureforresearchingtheepidemiolog-ical, clinical and genetic aspects of congenital heart defects. Itspatientdatabase isunique inEurope–a repository fortensofthousandsofdatasets.TheRegisteriscurrentlysup-portinganumberofmedicalandepidemiological researchprojectsseekingtoansweroutstandingquestionsregardingtreatment, long-term prognosis and living with a congenital heart defect. The ZeBanC is responsible for the collection of DNA,bloodandtissuesamplesfrompatientswithcongenitalheartdefects,theirrelativesandsuitablecontrolindividualswhicharemadeavailableforresearchpurposes.

Professionallyorganizedandcentralizedbiobanksareresponsiblefortheacquisition,processingandstorage of biomaterials as well as related data and making them available for biomedical research. Thesebiobanksguaranteethegenerationofreliableandreproducibleresearchdatabasedonwellcharacterizedbiomaterialssincequalitymanagementisofhighestprioritytothem.

“Due to increasing molecular subdivision of most diseases, even large biobankscannotprovidesufficientnumberofsampleswithveryspecificcharacteristics.Thus,networks like theGermanBiobankAlliance gain increasing importance in order togeneratecollectionsofsufficientsizeforresearchprojects.ThisalsorequiresIT-in-frastructurestoqueryforeligiblesamplesanddatainadditiontobiomaterialsofcom-parablequality.TheGermanBiobankAllianceiscoordinatedbytheGermanBiobankNodeandiscurrentlysettingupanationalbiobanknetworktobepreparedforfuturechallenges of advanced and reliable biomedical research. This complements the Europeanbiobanknetworks,activities in thecontextofBBMRI-ERIC forwhich theGermanBiobankNodeisthefocalcontactpoint.”

Michael Hummel HeadLaboratoryofMolecularPathology,Charité–UniversitätsmedizinBerlinNationalCoordinatorGermanBiobankNode(GBN),DirectoroftheCentralandInterdisciplinaryBiobankCharitéandBIH(ZeBanC)

©Thomas.M

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1717Services–FromAssayDevelopmenttoContractManufacturing

Services – From Assay Development to Contract Manufacturing

IntheOmicstechnologyfieldsnumerousservicesareavail-able. Examples for next generation sequencing serviceprovidersareAlacrisTheranosticsGmbHandAtlasBiolabsGmbH.TheProteomeFactoryAGisspecializedinprofes-sionalproteomicsandproteinanalysis.Thecompanyusesstate-of-the-art technologies for differential proteomics studiesandquantificationandvalidationofregulatedpro-teins,biomarkersandtargets.MetanomicsHealthGmbHisoneoftheglobalkeyplayersinthefieldofmetabolomics.Thecompanyhostsoneof theworld's largestmetaboliteprofilingfacilitiesandprovideshighlyrobustandreproduc-ible analysis of metabolite pathways and their changesin response to disease, pharmaceutical intervention, andnutrition.

Lots of regional players support customers with assaydevelopment services based on different technologies, withmanyofthemalsoprovidingmanufacturingservices. 8sens.biognosticGmbHofferscustom-madedevelopmentand production of immune-chromatographic lateral flowtests and microtiterplate-based assays. BST Bio SensorTechnologyGmbHfocusesontheconception,developmentand production of multi-way biosensors. Epiontis GmbHdevelopscustomizedepigeneticassaysandimmune-mon-itoringservicesbasedonepigeneticmarkers for immunecells.CellTrendGmbHisaspecialistforcellbasedbioas-sayswithafocusononcologyandimmunology.Glycotope

GmbH offers protein analysis and glycoprofiling servicesincludinghigh-throughputanalysisofcomplexglycosylationpatterns.Thecompanyalsosupportscustomersintheareaofprocesstransferforupstreamordownstreamprocesses.

Inadditiontoitshardwarebusiness,SCIENIONAGoffersservicesforIVDandRUOassaydevelopmentandISO-cer-tified diagnostic test manufacturing services. Customersinclude several globally operating companies. Combin-ing the expertise and technologies of two companies, the SpanishcompanyGENOMICAS.A.U.andSCIENIONhavejointlydevelopedanovelmultiplexbaseddetectionkit forthe identification and specific differentiation of 18 micro-organism causing sexualy transmitted infections (STIs). SCIENIONmanufactures themicroarrays for the test kit,utilizing its proprietary sciFLEXARRAYER non-contactprintingtechnology.

Regionalservicescompriseapplicationsintheentirefieldoflifesciences:BIOTECONDiagnosticsGmbHoffersmicro-biologicaltestingofpharmaceuticals,cosmetics,foodandbeveragesandBioTeZBerlin-BuchGmbHprovidesmyco-toxinandvitaminanalysisaswellasthedevelopmentandproductionofELISAtestsandimmunochemistryservices.The ifp Institut fürProduktqualitätGmbH isanaccreditedservicelaboratoryformodernfood,feedandpharmaana-lytics.

And finally, Berlin hosts the largest hospital laboratory inEurope:theLaborBerlin–CharitéVivantesGmbH.BeyondprovidinglaboratorydiagnosticsforpatientcareofVivantesandCharitéhospitals,LaborBerlinofferssolutionsforthediagnostics industry, for CROs aswell as for companiesfrom the life sciences and research facilities.

Regionalplayersinindustryandacademiaofferabroadvarietyoffirst-classservicesintheIVDandbioanalytics fields. Services are provided along the entire value chain and range from biomarkeridentification,highthroughputscreeningtechnologies,nextgenerationsequencing,systemsbiologymodeling,overassaydevelopment,technicaloptimizationandsoftwaresolutionstoclinicalvalidationstudiesandISO-certifiedcontractmanufacturingofIVDtests.

18 CreatingSynergies–CombiningBioanalyticswithOtherTechnologiesLeadstoCrossInnovation

Creating Synergies – Combining Bioanalytics with Other Technologies Leads to Cross Innovation

Interdisciplinarycooperationandthetransferofexpertisecanleadtocrossinnovationinanygivenareasorindustriesandtherefore,enablingcrossinnovationisakeytopicofregional,nationalandinternationalpoliticalagendas.OnededicatedobjectiveofthejointinnovationstrategyofBerlinandBrandenburg (MasterplanGesundheitsregionBerlin-Brandenburg) aimsat an increasedutilizationofcross-sectionaltechnologiesandtointensifycrossinnovationprocessesinthehealthcaresector.

The development of modern in vitro diagnostics and bioan-alytic tools involves the integrationof severalotherdisci-plinessuchasinformatics,opticaltechnologies,microsys-tems technology, microelectronics, material sciences,nanotechnology, process technologies and engineeringsciences, to mention the most important ones. Besides proven available outstanding competences in primarilyhealthcare-related disciplines like pharma, bioanalytics,biotechnology, biochemistry and medical technologies,theBerlin-Brandenburgregionprovidesauniquesciencesenvironment providing expertise in all the above mentioned fields.Keyregionalplayersof thesecross-sectional tech-nologiesareoftenorganizedinseparatenetworks–manyofthembroadeningtheiractivitieswithaspecificfocusonlife sciences applications.

Exchangeand collaborationsbetween regional IVDplay-ers and scientists from other relevant disciplines have been established by individual contacts and have furthermorebeenfosteredbyvariouseventsandnetworkingactivities.TheoverallconditionsinBerlin-Brandenburghaveprovedto be optimal for enabling cross innovation and thus toachieve a competitive edge.

19CreatingSynergies–CombiningBioanalyticswithOtherTechnologiesLeadstoCrossInnovation

OpticalTechnologies–virtuallyprovidinginsights

InnovationsforthedigitalsocietyofthefuturearethefocusofresearchanddevelopmentworkattheFraunhoferInstituteforTelecommunications,HeinrichHertz Institute,HHI.ThePhotonic Component Department develops semiconduc-torandpolymer-basedoptoelectroniccomponents,aswellasintegratedopticalcircuitsfordatatransmission.Anotherfocusisoninfraredsensorsystems,terahertzspectroscopyand high-performance semiconductor lasers for industrialand medical applications. Scientists have developed optical multi-sensors based on microring resonators which allowfor label-free multi-parameter analysis. The cost-efficientsilicon-basedchiptechnologyissuitableforapplications inpoint-of-care diagnostics, food and drinking water control, as wellasforthedetectionofhazardoussubstances.

The Federal Institute forMaterialsResearch andTesting(BAM) is a senior scientific and technical federal author-itywithresponsibilitytotheFederalMinistryforEconomicAffairsandEnergy(BMWi),withresearch,testingandcon-sultationinthefocusareasInfrastructure,Energy,Materi-als,Environment,andAnalyticalSciencesunderoneroof.The focus of the Biophotonics division, headed by UteResch-Genger, lies inmultiparametricopticalmethodsforthemeasurementandcharacterizationoftheinteractionof

materials and light, for example in applications in materials research,bioanalytics,medicaldiagnostics,environmentalchemistry,pharmaceuticals,bioengineering,andfoodtech-nology.Theresearchincludesthedesign,traceablespec-troscopic characterization, and application of functionalorganic, inorganic, and hybrid molecular and nanoscalechromophoresystemsandbioconjugatesaswellassignalenhancement andmultiplexing strategies, absolutemea-surementsofspectroscopickeyperformanceparameters,and the development of reference materials for optical measurements.

Ilko Bald leads the Optical Spectroscopy and ChemicalImaginggroupwhichissituatedbothinthePhysicalChemis-tryDepartmentattheUniversityofPotsdam,andBAM.Thegroupcombinesdifferentmethods fromDNAnanotechnol-ogy,opticalspectroscopyandscanningprobemicroscopyinordertostudyphysico-chemicalprocessesatthesingle-mol-eculelevel.Inseveralprojects,DNAnanoscalefoldingtech-niques (Origami) are used as versatile tools for arrangingfunctionalitieswithhighlocalcontroltostudymolecularpro-cessesatasingle-moleculelevel,e.g.tocreatehighly-selec-tiveFörsterresonanceenergytransfer(FRET)-basedsens-ing tools or switchable photonic wires.

Optical technologies have a long tradition in Berlin and Brandenburg and today Photonics and Microsystems Technology representsoneofthefivecapitalregionclusters.Playersinbioanalyticsanddiagnosticsbenefitfromtheextraordinaryregionalcompetenceinopticaltechnologies.Incollab-orativeR&Deffortstheyaredevelopingagreatvarietyofbiomedicalandotherbioanalyticalapplica-tions–fromsophisticatedmicroscopytechniquestohigh-endopticalsensors.

“Accurate,reliableandcomparablemeasurementdataaremoreandmoreindispens-ableprerequisitesandimportantcomponentsforemergingdevelopmentsinthelifesciences and health care, like precision and personalizedmedicine.Metrology forin-vitrodiagnostic andbioanalytical proceduresbasedonoptical technologiespro-videssupportandenablessolutionstothisend.PracticalworkatPTBcomprisesthedevelopmentandprovisionofreferencemeasurementprocedurestodetermineaccu-ratetargetvaluesinexternalqualityassuranceschemesformedicallaboratories,tosafeguardmetrologicaltraceabilityofaccreditedreferencemeasurementlaboratories,andtoassignvaluestoreferencematerialsormeasurementstandards.”

Rainer Macdonald Physikalisch-TechnischeBundesanstaltHead of Department Biomedical Optics

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The working group of Fred Lisdat, Chair of BiosystemsTechnologyandDirectoroftheInstituteofAppliedLifeSci-ences, Technical University of Applied Sciences Wildau(TUASW),isfocusedonapplyingopticalandelectrochemi-caltechniquesinbioanalysis.Specialcompetenceisinthecombination of nanostructures with biological moleculesand photoelectrochemical detection systems.One exam-ple is an optical test to determine protein concentrations in cerebrospinalliquids.Thefast,simpleandsensitivepoint-of-caresystembasedongoldnanoparticleswasdevelopedincollaborationwiththecompaniesLIMETECBiotechnolo-giesGmbHandIn.ventDIAGNOSTICAGmbH.

Another project at TUASW addresses a combined solu-tionformobilemicroscopyandimageanalysis.ThegoalofMarcusFrohme’sgroupattheFacultyofEngineeringandNaturalSciencesistodevelopasystemformobileimageprocessingincludingautomatedevaluationofmicroscopicimages which are taken with the help of an optical attach-mentformodernenddevicessuchastabletPCsormobilephones.Firstapplicationstargettheanalysisofbeeryeasttocontrol the fermentationprocess.Successful resultsofthiswork have already led to the foundation of the spin-offOculyzeGmbHin2016.Futureapplicationsrangefromagriculturalmonitoring to a point of care device for ruralareas.

At the Biomedical Optics Department of the Physika-lisch-TechnischeBundesanstalt(PTB),theNationalMetrol-ogy Institute of Germany, measurement procedures aredeveloped,examinedandtestedinthefieldofflow-cytom-etry,nano-flowmetry,quantitativemicroscopyandquantita-tivenucleicaciddiagnosticsofcellsand(bio-)molecules.Research and development projects of the departmentheaded by Rainer Macdonald are conducted in closecooperationwithclinical,industrialandacademicpartnersto support e.g. laboratory diagnostics. One goal of thiswork is the development of referencemeasurement pro-ceduresandvalues, toenableandsupportqualityassur-ance schemes of tests in laboratorymedicine.Non-inva-sive quantitative determination of important biomarkers(e.g. concentration of hemoglobin, oxygen saturation) intissue,aswellasinvivoimagingofpathologicalchangesusing fluorescence-labeled probes, round out the tasksof the department. For this purpose, opto-spectroscopicmeasurementandimagingtechniquesaredevelopedandexamined.ContactpersonsforflowcytometryandparticleanalyticsareJörgNeukammer,andDirkGrosenickforopti-calmedicalimaging,respectively.

CreatingSynergies–CombiningBioanalyticswithOtherTechnologiesLeadstoCrossInnovation

21CreatingSynergies–CombiningBioanalyticswithOtherTechnologiesLeadstoCrossInnovation

MicrosystemsTechnologyandMicroelectronics–integralpartsofminiaturizedbioanalyticaltestsystems

Microsystemstechnologyisregardedasthekeytechnologyofthe21stcenturyworldwide.Thedevel-opmentofmoderninvitrodiagnosticsisinconceivablewithoutmicrosystemstechnologiesasthesetestsaremicrosystemsthatcombinedifferentmaterials,componentsandtechnologieswithinasmallspace.Microsystemstechnologyandmicroelectronicsbecomeevenmoreimportantwithregardtothegrowingdemandforminiaturizedtestformats.

One research focusof the IHP Innovations forHighPer-formanceMicroelectronics / Leibniz-Institut für innovativeMikroelektronikaddressessmartsolutionsforthedetectionand quantitative determination of biomolecules by apply-ingmicroelectronicstechnology.The“GlucoPlant”project,leadedbyMarioBirkholz, focusedonthedevelopmentofanimplantableglucosesensorchiptocontinuouslymoni-torbloodsugar.Thechipwasdevelopedasafullyembed-dedmicroelectromechanicalsystem(MEMS),inwhichtheviscosityofa liquid isdetermined fromthebendingofanelastic cantilever. Modern micro technologies allowed the sensorchiptobefullyoperativeatminiaturedimensionsof1.3x0.4x0.2mmonly.

Microelectronicsandbiotechnologyarecurrently involvedin a convergence process bringing both disciplines closer togethertointegrateelectronicsystemsinbiologicalenvi-ronments. Major developments are concerned with the fieldofbiosensors,where theprogressiveminiaturizationenabled the introduction of micro-sensors into biologicalsystems. To better address these developments, the TUBerlinandtheIHPfoundedthe“JointLabBioelectronics"in2012.Currentprojectsincluderesearchonnewapproachesfor sensor-based metabolite monitoring, high-frequencyimpedancespectroscopy forcellmonitoring,cellhandlingbydielectrophoresisor theoptimizationofsemiconductorinterfacestoimprovebiocompatibility.

Scientists of the Faculty of Engineering andNatural Sci-ences at the Technical University of Applied SciencesWildauand from the IHPhavedevelopedahybrid-wave-guide ring resonator for on-chip biochemical sensing. Bycombiningalow-lossstrip-waveguideandahighlysensitiveslot-waveguideintegratedinasiliconphotonicplatform,thenewtestsystemachievesanincreaseinsensitivity,whilemaintaining lowoptical losses.Thus,thisresonatorstruc-ture may represent a promising alternative approach forfutureintegratedbiochemicalsensingapplications.

IHP Innovations for High Perfor-mance Microelectronics/ Leibniz-Institut für innovative Mikroelek-tronikThe IHP performs research and developmentinthefieldsofsili-con-basedsystems,highest-fre-quencyintegratedcircuits,and

technologiesforwirelessandbroadbandcommunica-tion.Thefocusofresearchattheinstituteisorientedtowardsissuesrelevantforbusiness,resultinginapplicationsfortelecommunications,semiconductorandautomotiveindustries,aerospace,telemedicine,andautomationtechnologies.The IHP provides an important bridge between aca-demiaandindustry.TheJointLabswithuniversitiesintheBerlin-Brandenburgregionhavebeenparticularlysuccessfulinthiscooperation.AsteadilyincreasingnumberofinternationalusersoftheMulti-ProjectWaferandPrototypingServicesdemonstratetherec-ognizedcompetenceoftheIHP.

innovationsfor highperformance

microelectronics

22

The successful development of cell-derived productsrequires a combination of deep scientific knowledge anda thorough understanding of process engineering. PeterNeubauer, Chair of the Bioprocess Engineering Depart-ment atTechnischeUniversitätBerlin, clearly claims thatconsistent application of process engineering strategies whichare focusingdirectlyon the industrial scale shouldalreadybeinuseinearlyproductdevelopment.Thisideais also reflected in theQuality byDesign (QbD) conceptwhichpostulatesseveralqualitytestsasearlyastheprod-uctdevelopmentprocesstoenableamoretargetederroridentificationandamoreefficienterror reduction is tobemadepossible.ThisconceptasanintegralpartofqualitymanagementwasfirstoutlinedbyJosephM.Juranandisusedbydifferentindustries.Withregardtotheproductionofpharmaceuticals, theapplicationofQbDprinciplesaremandatory after they have been included into regulatoryguidelinesoftheU.S.FoodandDrugAdministration(FDA)incooperationwiththeEuropeanMedicinesAgency(EMA).

The working groups at Neubauer’s department addressseveral challengesof current life science-relatedprocessengineering. They aim to advance bioprocess scale-upand scale-down, process analytical technologies (PAT),dynamicmodellingandoptimizationofbiologicalsystemsas well as automated bioprocess development.Addition-ally,theyworktooptimizecellandsystemsbiologyappliedtomicrobialbioprocessesandbiocatalysisapplications.

PATprojectsincludethedevelopmentofnovelmonitoringmethodsforprocessdevelopmentandproduction.Multipo-sitionandmultiparametersensors(MMS)allowforrealtimein situmonitoring of process performance in bioreactors,while the development of novel optical sensors is aimed at insitumonitoringofcellpopulationhomogeneityandcellviabilityforvariousapplications,e.g.brewingorbiogaspro-duction.

CreatingSynergies–CombiningBioanalyticswithOtherTechnologiesLeadstoCrossInnovation

ProcessTechnologiesarecross-sectionaltechnologiesinvolvedinalmostallfieldsofbiotechnologicalproduction.Theyareanintegralpartofanybioanalyticalproceduresandkeyforcontrollingcomplexandhighlyautomatedbioprocessesinvariousareas,includingrecombinantdrugmanufacturing,culti-vationofcells,aswellasbiogasandbiomassproduction.Regionalexpertsofbioprocessengineeringarecommitted toaccelerating thedevelopmentofbioprocessesand tomeetingcurrent trends forimprovedprocessautomationandQualitybyDesignapproaches.

“Characterizationofindustrialreactors,scaleupandscaledowntechnologies,andahigherdegreeofautomationinbioprocessdevelopmenturgentlyneednewanalyticaltechnologies,suchasabroaderrangeofnon-invasiveandmultipositionon-linesen-sorsandmodel-basedsoftsensors.WhileourBio-PATBerlin-Brandenburgnetworkon ProcessAnalytical Technologies (PAT) integrates partners from different fields,miniaturizedsiliconbasednewanalyticaltoolsaredevelopedinourJointLabBioelec-tronicstogetherwiththeIHPLeibnizInstituteFrankfurt/Oder.ThevisonofintegrationofautomationandcomputationisestablishedintheLaboftheFuturethatiscloselyrelatedtoourBioPilotplantwheretheprocessesarevalidatedinanenvironmentthatisclosetoindustry.”

Peter NeubauerHeadBioprocessEngineering,DepartmentofBiotechnology,TechnischeUniversitätBerlin

ProcessTechnologies–accompanyinglifesciences fromR&Dtomanufacturing

©OlgaSheshukova

23CreatingSynergies–CombiningBioanalyticswithOtherTechnologiesLeadstoCrossInnovation

Theintegrationofmaterialsciencesintobioanalyticsoffersnewandimprovedtestmethods.Pursuinginnovativeapproachesusingtailor-madefunctionalpolymersleadstonovelproductfeaturesandcanovercomelimitationsofconventionalanalyticaltools.

PolymersurfacechemistryforbiologicallyactivematerialsrepresentsonecoreareaoftheresearchattheFraunhoferInstitute forAppliedPolymerResearch IAP.ThegroupofAndreasHolländer develops technologies that allow sur-face properties – in particular polymer surfaces – to beadapted to meet application requirements. Dedicatedresearchefforts targeted the functionalizationof surfacesused inqualitycontrol in the food industry.Thescientistshavesuccessfullydevelopedmaterialsforthequalitycon-trolofbeverages.Functionalizedpolymerpowdersspeedupthesamplepreparationforthedetectionofbacteriaandyeasts.Themethodshowsclearadvantagescomparedtotraditionalmembranefiltrationmethodsandcanbeappliedforlargesamplevolumes.

Inaddition,severalregionalcompaniesareactiveinpoly-mer research – often in joint projects with academic insti-tutions–andaredevelopingspecializedproducts for lifescienceapplications.PolyAnisananotechnologycompanyspecializedinthemodificationofsurfacesusingMolecularSurface Engineering. The company is a leading supplierof functionalized microarray slides, coverslips and mem-branesformoleculardiagnosticsandlifescienceresearchapplications.PolyAnoffersaportfolioofpolymermicropar-ticlesformultiplexbeadassays,calibrationofflowcytom-eters and calibration of fluorescence imaging systems.

WithPolyAn’sproductionprocessup to twofluorophoresare incorporated intothebeadsduringthepolymerizationprocess–therebyensuringahomogeneousdistributionofthedyeswithin thebeads.Beadsareoffered in differentsizesandcanbeequippedwithawiderangeoffunctionalsurfaces.

The key technology ofSurflayNanotecGmbH is its pro-prietary Layer by Layer (LbL) technology with chargedpolymers(polyelectrolytes).Usingthistechnology,macro-scopicaswellascolloidalsurfacesarefunctionalizedonananoscale.Thecombinationofphysicochemical functionsand biological properties separated by nanometer-thicklayersallows theuniquemodificationof thesurfacewith-outanygreatdifficulty.Areasofapplicationincludemodernseparating materials, substance encapsulation, enzymeimmobilizationaswellassensoryordiagnosticbeads.Thecompanyalsooffersabroadrangeoffluorescent labeledpolymers.

Further regionalR&Defforts towards functionalmaterialstargetapplicationsbeyondbioanalytics,e.g.polymer-basedantimicrobialcoatings,novelsystemsfordrugdeliveryandpolymer-based materials for applications in tissue engi-neering and regenerative medicine.

“The separation and enrichment of cells and microorganisms are a major problem in diagnostics,especiallyiftherearelargesamplevolumesandsmallconcentrations,orviscousorsolid-ladensamples.AttheFraunhoferIAPinPotsdam,apolymerpowderwithafunctionalizedsurfacewasdevelopedtogetherwiththecompanyGEN-IALfromTroisdorf.Thispowderisusedtobindmicroorganismsfrombeveragessuchasbeerandjuices.ThepowdercanbeseparatedeasilyandthemicrobescanbeidentifiedandquantifiedusingtechniquessuchasPCR.Thetimeforincubationcanbereducedsubstantiallycomparedwithtraditionaltechniques.”

Andreas HolländerSeniorscientistatFraunhoferInstituteforAppliedPolymerResearchIAP

MaterialSciences–enhancingbioanalytics byuseoffunctionalpolymers

©FraunhoferIAP,FotografinManuelaZydor

24 MoreInnovationthroughCooperation–NetworksFacilitateCollaborativeEfforts

DiagnostikNet-BB

TheDiagnostik Berlin-Brandenburg e.V. network bundlesthe competencies of innovative companies, renowned international research institutions,clinicsand laboratoriestojointlydevelop,manufacture,andsellinvitro-diagnosticproducts. DiagnostikNet-BB combines the diverse areasofexpertiseofmorethan70members,coveringtheentiresupplychainforinvitrodiagnostics.Sinceitsfoundationin2007, theassociationhasbrought togetherpartners fromBerlin-Brandenburgandsixotherfederalstates.

Highlyspecializedpartnerstakeastakeinthenetworkcov-eringthewholetechnologyspectrum:• sampledelivery,biobanking• biomarkerfinding,development,andvalidation(genetic,

epigenetic,proteins&cell-basedmarkers)• platform-independentassaydevelopment• detectionsystems,biosensors,devices• biochips,microarrays,multi-parameterbioassay• point-of-care testing, companion diagnostics• software, bioinformatics, data management• laboratoryautomation• certification,accreditation• servicesinclinicalchemistryandmoleculardiagnostics AllmembercompaniesarecertifiedaccordingtotherequiredISOnormsandhenceguaranteequality.Renownedpart-nerswithexpertises in theareaof certification,approval,reimbursementandpatentlawcompletetheportfolio.

Inadditiontohumanmedicinediagnostics,otherfieldsofapplication include veterinary diagnostics, mobile health,food,andagriculture&environment.Clientsprofitfromindi-vidualized,user-orientedproductsolutions.

Thenetwork’ssubsidiary,DiagnostikBBGmbH, isapro-fessionalseminarandworkshopproviderandsuppliesvar-iousconsultingandprojectmanagementservicesspecial-izedontheinvitrodiagnosticsarea.

www.DiagnostikNet-BB.de

www.diagnostik-bb.de

More Innovation through Cooperation – Networks Facilitate Collaborative Efforts

Efficientnetworkingadvancesresearchanditstransferintoinnovativeproducts.SeveralnetworksinBerlinandBrandenburgserveasplatformsforintenseinteractiontopromotecooperationsandtheintegration of different areas of expertise.

“TheDiagnostikNet-BBcombinestheexpertiseofoutstandingmedium-sizeddiagnos-ticscompanies,laboratories,researchinstitutesandcompetencepartners,whichareexemplaryforthestrengthandinnovationpotentialoftheBerlin-Brandenburgregion.Withmembers innoweightfederalstates, thenetworkgoesfarbeyondthecapitalregion.Allpartnershavemore than6,000employeesanda turnoverofmore than300millioneurosperyear.Additionally,thenumberofnetworkcollaborationsisquiteremarkable:about500projectshavebeeninitiatedsincethefoundationofthenet-workin2007.”

Frauke AdamsOfficeManagerDiagnostikNet-BB

©Diagnostik-NetBB

25MoreInnovationthroughCooperation–NetworksFacilitateCollaborativeEfforts

PolyMed

ThePolyMednetworkwasfoundedby10companies(SME)andtheTechnicalUniversityofAppliedSciencesinWildaualong with other associated research partners in 2014. Its mainfocusreliesonthecombinationofnewtechnologiesinplasticsengineering,automationtechnologiesandmedicaltechnologies.

Our partners strive to achieve new products, new pro-cesses and technologies to offer unique as well as cus-tom tailored solutions to customers. Examples of thecooperation between the partners are the development of a sophisticated sampling and storage device with inte-gratedpre-samplefiltrationfullyautomatedandcustomiz-able.Anotherfocusliesontheprintingofindividualhumanorgansbasedontissue-likeplasticmaterials.

Ourpartnersare:• AbacusAnalyticalSystemsGmbH• AnalyticalControlInstrumentsGmbH• bbi-biotechGmbH• ChristmannKunststofftechnikGmbH• CybertronGmbH• HerotronMedicalDeviceSterilization• HumanXGmbH• MotzenerKunststoff-undGummiverarbeitungGmbH• PolymericsGmbH• RoweMedAG-Medical4Life

www.polymed.info

European Diagnostic Clusters Alliance (EDCA)

TheEuropeanDiagnosticsClustersAlliance(EDCA)istheassociationofpublicandprivateclusters focusingon thedevelopment andproduction of new solutions for in vitrodiagnostics.

Thepurposeoftheassociationis:• to promote competitiveness of European industry in

the area of medical diagnosis. To this end, the associ-ationwillenhancethesynergiesbetweenacademicalsresearch,clinicalresearch,healthauthoritiesanddiag-nosticcompanies;

• to facilitate the growth of European SMEs in medical diagnostic;

• topromotethedevelopmentofdiagnosticclustersandcompetitivenessclustersinEurope;

• to promote cooperation between diagnostic clusters (inter-cluster)inordertohelpbuildEuropeancollabora-tive projects.

www.edc-alliance.eu

26 FutureOpportunitiesandChallenges–aPerspective

Future Opportunities and Challenges – a Perspective

Theglobalinvitrodiagnosticsmarketaccountedformorethan$60billionin2016andleadingmarketresearchcompaniesexpectthismarkettogrowataCAGRof4.6–5.4%inthenextfiveyears.Keydriversof thisdevelopment include theagingpopulation, the identificationofnewbiomarkers, theincreasingdemand for diagnosticsenablingpersonalized therapyapproaches, and theexpansionof IVD companies to emerging markets. Advancements in point-of-care testing and companion diag-nosticsalsocontributetothegrowthrate,andfinallyabetterinformedpublicresultsinpatient-drivendemands.However, inadequate reimbursementpoliciesandstrict regulatory requirements for IVDproductionwillremaintobechallengingissuesinthefuture.

“BerlinandBrandenburgisatraditionalhotspotforthedevelopmentofinvitrodiag-nostics.Thediscoveryofnewbiomarkers,thedevelopmentofinnovativetechnologiesandtheirimplementationinmedicalapplicationsarenotdoneseparately,butinclosecooperationswithallstakeholdersinR&D.Thisisoneofthemostimportantadvan-tagesofthecapitalregion,whereprojectsalongtheentirevaluechainarepossible.TheinitiationandperformanceofthosecollaborationsarestronglysupportedbytheclustermanagementofHealthCapital.Therefore, theBerlin-Brandenburg region isyourfirstpointofcontactforthedevelopmentofnext-generationinvitrodiagnostics.”

Christine Mißler ClusterHealthcareIndustriesBerlin-BrandenburgHealthCapital,Project Manager Biotech I Pharma

© BerlinPartner-FotostudioCharlottenburg

SteadyprogressintheOmicstechnologieswillleadtoanincreasingnumberofnewbiomarkerswithdistinctfeaturesenablingpersonalizedmedicine.Thesedevelopmentswillbe furtheracceleratedbyabetter integrationofgenomic,proteomic,metabolomicandglycomicinformation.

Point-of-Care (POC) testingwill continue to be a field ofexpansion in the future.On theonehand,POCtestswillmoveclosertothepatientorconsumerandpersonalmobilediagnostics facilitating disease management as known for diabetes will expand to other diseases as well. On the other hand, there is a great demand for low cost diagnostics plat-formsfordeploymentworldwide,especiallyinresource-lim-ited settings.Current trends targetingminiaturizationandmultiparametertestingwillbeongoingandwillcontributetocostreductionandmoreefficiency.

Berlin-Brandenburghasextraordinaryexpertiseintheareasofinvitrodiagnosticsandbioanalytics.About100compa-nies and more than 20 research facilities are committed to IVDandcovertheentirevaluechain.Duetotheexcellentresearch environment and various networking activities,the integrationofcross-cutting technologies like informat-ics,opticaltechnologies,microsystemstechnology,micro-electronics, material sciences, nanotechnology, processtechnologies and engineering sciences works smoothly.Regionalplayersdevelopsolutions fornextgeneration invitro diagnostics and bioanalytics such as sensor-actormolecules and autonomous biosensors, DNA-, protein-andglycan-basedmultiplexanalytics.Techniques includestate-of-the-artmicroarrayandbeadtechnologies,Lab-on-a-chiptechnologiesaswellasseveralproprietaryplatformtechnologies are enabling further progress in diagnosticsandtherapy.

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28 DirectoryofRegionalPlayers

Companies

3B Pharmaceuticals GmbH

3BPharmaceuticalsGmbH(3BP)isaprivatelyheldpharmaceuticalR&DcompanybasedinBerlin,Germany.Thecompanyisdedicatedtothedevelopmentofpeptide-basedpharmaceuticalanddiagnosticproducts.3BPispursuingprojectsinhemophiliaandnuclearmedicine.

3b-pharma.com

8sens.biognostic GmbH

8sens.biognostic develops, produces and sells rapid tests (lateral-flow) and ELISAs for differentmarkets(humanandveterinarydiagnostics,foodcontrol).OurproductsaretheQuickSens®-tests for h-FABP, TropI, CRPandhs-CRPandtheReaderforquantificationQuickSens®OMEGA.Development-on-demand,feasibilitystudiesandproduction-on-demandarealsooffered.

biognostic.de

Acuros GMBH

Development of osmotic micropumps for medical or microfluidic applications. The innovative technologyenablesnewoptionsin liquidhandling–fromdisposablemicropumpsfordrugdeliverytoprecisionmicro-pumpsforlab-on-a-chipdevelopment.

acuros.de

Adrenomed AG

AdrenomedAG is a privately financed, clinical stage biopharmaceutical company focusing on endothelialdysfunctionand impairedvascular integrity.Wedevelopsafefirst-in-class therapies for the treatmentandpreventionofimpairedvascularintegrity,whichisoneunderlyingpathophysiologyofavarietyofcriticalcareconditionslikesepticshockandacutecongestiveheartfailure.LeadcandidateAdrecizumabisahumanizedmonoclonalAdrenomedullin-specificantibody,currentlyinvestigatedinaPhase-IIstudyinpatientswithearlysepticshockstratifiedforthebioactivetargetexpressionbyaproprietaryIVDassay.

adrenomed.com

AFOSA GmbH

Development,productionandmarketingofdiagnostics(ELISAkits),primarilyforuseinveterinarymedicine. afosa.com

AJ Innuscreen GmbH

TheAJInnuscreenGmbHisayounglifesciencecompanyworkinginthefieldofbiotechnologyandbooststhelifescienceunitofAnalytikJenaAG.Innovativetechnologiesandproductsaredevelopedandproducedfor the isolationandpurificationofnucleicacids.Reagentsystems formolecularbiology,aswellas tech-nologiesandproductsformoleculardiagnostics,arealsoincludedintheproductportfolio.ThecompanyisENISO9001:2008andENISO13485:2003+AC:2009certified.

aj-innuscreen.de

Alacris Theranostics GmbH

AlacrisTheranosticsGmbHisasystemsmedicinecompanybasedinBerlinspecializedindevelopinginno-vativeapproachesforcancerprecisionmedicineanddrugdevelopment.Withitsaward-winningportfoliooftechnologies–ModCell™,NGSight™&Oncovar™–Alacrisdeliversauniquecombinationofdeepmolecularinsight and predictive modelling that is set to shape the cancer care landscape, from diagnosis and treat-menttotargeteddrugdevelopment.Alacrishasbuiltupahighlyqualifiednetworkofcollaboratorsincludingrenownedclinics,academicsandpharmaceuticalcompanies,toacceleratethetranslationofresearchinno-vationsandtechnologiesintodirectbenefitsforpatients.

alacris.de

Alcat Europe GmbH

AlcatEuropeGmbHisthedaughteroftheUScompanyCellScienceSystems,theoriginaldeveloperoftheAlcattesttechnology.Thecompanyisspecializedtoidentifyintolerantreactionsoftheleucocytestoforeignsubstanceslikefoods,drugsorchemicals.

alcat-europe.com

AnaKat Institut für Biotechnologie GmbH

AnaKatInstitutfürBiotechnologieGmbHhasspecializedonanalyticaldeterminationofpharmaceuticalingre-dients.

anakat.de

Analyticon Discovery GmbH

AnalytiConisabiotechnologycompanyfocusingonthedevelopmentofcompoundlibrariesconsistingofnat-uralproduct(NP)andsyntheticsmallmolecules.AstheglobalmarketleaderinNPsmallmoleculescreeningcompounds,AnalytiCon is theonlycompanywhich isable toprovidevastcollectionswithcompletelydis-closedstructuralinformation.Asapurecompoundproviderthecompanyisofferingitsproductsandservicestothepharmac.,chemical,biotech,cosmeticalandnutraceuticalindustry.

ac-discovery.com

Directory of Regional Players Involved in IVD and Bioanalytics

29DirectoryofRegionalPlayers

AnaTox GmbH & Co. KG

TheAnaToxGmbH&Co.KGdealswiththedevelopmentandoptimizationofanalyticalmethodsanddevicesforHPLCanddissolution.

anatox.de

Aokin AG

AokinAGisaBerlinbiotechnologycompanythatisspecializedinthedevelopmentandcommercializationofinnovativeanalyticalsystemsonthebaseoftherapidkineticassaytechnology.Theaokinsystemsareuniqueintheirprecisionandoperatingspeed.Areasofapplicationarefoodandantibodyanalyticsaswellasclinicaldiagnostics.Wealsoofferlaboratoryservicesintheareaoffoodanalytics,Pharmacoanalyticsandchemicalsynthesis.

aokin.com

Aptarion biotech AG

AptarionbiotechdevelopsbiostableL-aptamersforthetreatmentoflife-threateningdiseasesandforbiosen-sors.SpearheadforourtherapeuticstrategyisAON-D21thatbindsandinhibitsthecomplementproteinC5awithauniquemechanismofaction.Encouragingpreclinicaldatainseveraldiseasemodelssupportthedevel-opmentofAON-D21inindicationssuchasseverepneumonia,sepsisor lungcancer.BasedonarecentlyestablishedproprietaryandbroadlyapplicabletechnologytoimmobilizeL-aptamersonvarioussensortypes,we plan the development of novel biosensors together with partners.

aptarion.com

Astra Biotech GmbH

AstraBiotechGmbHoffershighqualityreagents,allergens,antibodies,recombinantproteins,andassaysforthedeterminationofhormones,allergies,tumourmarkersandinfectiousdiseases.QualityisoneofthekeycornerstonesonwhichAstraBiotechmaintainsitsreputationandwithwhichwestrivetoincreasecustomersatisfactionandgaingrowingcustomerloyalty.Wetakegreatprideinourhighestqualityassays,whichareallIVDcompliantandthereforesuitablefordirect,accurateandreproduciblediagnosticpurposes,aswellasfor research.

astrabiotech.de

ATLAS Biolabs GmbH

ATLASBiolabsGmbHisaleadingproviderofmicroarraybasedgenomicservicessuchasgenome-widegeneexpressionandSNPanalysis,CGHanalysisanddiagnosticservicesforregistereddoctorsandhospitals,aswellasforpharmaceutical,biotechnologicalanddiagnosticenterprises.

atlas-biolabs.com

Attomol GmbH Molekulare Diagnostika

Thecompany’saimistodevelop,produceanddistributemedicaldiagnosticsforhumanmedicineinthefieldofmoleculargenetics,infectiousandautoimmunediseases.

attomol.de

BDW Berliner Diagnostik Werke GmbH

BDWBerlinerDiagnostikWerkeGmbHwas founded in2017 todevelop,manufactureandcommercializenewdiagnostic technologies that leverage thepotential of carbohydrate-science for sensitiveandspecificmultiplexassaysolutions.Firstproductdevelopmentsfocusondiagnosticassaysfordeterminingthegeneralvaccinationstatusaswellascompaniondiagnosticsforvaccinationstatusrelatedtospecificvaccines.Otherapplicationsincludetheanalysisofspecificallergies,autoimmuneandinfectiousdiseases.Businessareasincludethedevelopmentofownproductsandcustomizeddiagnosticsforthehealthcareindustry.

BG Berlin-Genetics GmbH

BGBerlin-GeneticsGmbHisanewproviderforgeneticdiagnosticsandconsultingingeneticdiagnostics.Weareateamofexperiencedhumangeneticistsandhaveworkedformanyyearsinthefieldofhumangeneticscienceandhumangenetic diagnostics.Our aim is thedevelopment of innovative cooperation concepts,toconnectclassicalpatient-basedmedicalcarecenterswithmoderntechnology-basedservicecenters. Infuture,thesecooperationformswillenableefficient,highquality,andpatient-basedgeneticdiagnostics.

bg-berlin-genetics.de

Bioanalyt GmbH

Bioanalytdevelopsanddistributestheworldwidefirsteasy-to-useandportabletestkitsfortheanalysisofvita-minsandmicronutrients.TheiCheck-iExtestkitsenablefoodproducers,foodauthoritiesandNGOstomon-itortheironglingfoodprogramsmoreefficientlyandatlow-cost.Thecompanywasfoundedin2006byProf.Dr.F.J.Schweigertasaspin-offoftheUniversityofPotsdam.Readmoreonourwebsitewww.bioanalyt.com.

bioanalyt.com

BIOCYC Gesellschaft für Biotechnologie und Recycling mbH & Co.KG

Productionofbio-chemicals,peptides, invitrodiagnostics, test-kits.Developmentofconsumerservice forpeptides and biochemicals.

quartett.com

BioGenes GmbH

BioGenes isa full-service immunoassayandantibody(monoclonalandpolyclonal)developmentcompanywithoutstandingproblemsolvingcapabilitiesspecializinginchallengingprojectsthatarecarriedoutbyanexceptionallyexperiencedandinterdisciplinaryteam.

biogenes.de

30 DirectoryofRegionalPlayers

Bioline GmbH

Ourmissionistoprovidecustomerswitharangeofproductswhicharefastandeasytouse,guaranteedtoworkanddevelopedbyscientistswhounderstandwhatourcustomersaretryingtoachievesotheycanfocusontheirscientificgoals.Biolinereagentsareusedbymolecularbiologistsandotherresearchscientists toperformtest-assaysandresearchinmanyfieldsfrommedical,biotechnologyandmarinebiology.

bioline.com

biotechrabbit GmbH

biotechrabbitGmbH isdetermined tooffer thenewestandbest lifescienceproductsand innovativesolu-tions toscientists leading thefightagainstdiseaseand fuelingour liveswith innovations.Wesupplyultrapureenzymesandhigh-qualityantibodyservicesfordiagnosticsandalifescienceproductportfolio(includ-ingreagentsforPCRandnucleicacidpurification)formolecularbiologyandproteomics.Thebiotechrabbitadvantageisourcombinationofpassionforexcellentresearchwiththeagilityoftrueentrepreneurship.

biotechrabbit.com

BIOTECON Diagnostics GmbH

BIOTECONDiagnosticshasbeenwellknownasaqualifiedpartnerinthefieldofmolecularandmicrobiologyformorethan15years.Wefocusondevelopment,productionandmarketingofPCR-basedrapiddetectionsystems.BIOTECONDiagnosticsofferssolutionsforthefoodandbeverageindustryaswellasforproducersofpharmaceuticalsandcosmetics.

bc-diagnostics.com

BioTeZ Berlin-Buch GmbH

Services (custom DNA and RNA oligonucleotide synthesis, immuno affinity columns) – development ofenzymeimmunoassays,e.g.fortherapeuticantibodies–bioconjugates–immobilizationofbiomoleculesforbettersignalling-R&D(aptamer).

biotez.de

biotx.ai GmbH

ClinicaldatasetsaredifficulttoanalyzebyreportedMachineLearningapproachesduetotheirsmallsamplesandmanyfeatures.Ourapproachisabletoidentifysignificantpatterns,whichcanbeusedfornoveldiagnos-tics and therapies.

biotx.ai

BST Bio Sensor Technology GmbH

BSTdevelopsandproducesbiosensors toprovidehighqualityanalysisatmoderateprices. In1982BSTbroughton themarket thefirstmulti-waybiosensorbasedbloodglucoseanalyzer inEuropeand issincethenmarketleaderinEurope.TodayBSTsellsmorethan60.000sensorsayear.Since2008BSTisbesidesbiosensorsalsomanufacturerofPOCTandlaboratoryinstruments.

bst-biosensor.de

Caprotec bioanalytics GmbH

CaprotecsCaptureCompoundMassSpectrometry (CCMS)Technologyallowsseparationand isolationofproteinsbasedonfunctionality.Formanyapplications,CCMSisclearlysuperiortoconventionalmethods–thusaddressinganunmetneedintheproteomicsresearchcommunity.ThecompanyiscommercializingtheCCMStechnologythroughImproMedprojectswithpharmaceuticalandbiotechnologycompanies.Thefocuson thesecollaborations ison investigatingmechanismsofdrugaction (MoA)and identificationofon-andoff-targetproteinstounderstandpotentialadverseeffectsofdrugcandidatesonamolecularlevel.Thiscanbeeasilycarriedoutintheleadoptimizationprocess,orevenearliertoincreasetheprobabilityofsuccesslater on in the clinic.

caprotec.com

CellTrend GmbH

Celltrend is certified according to ISO 9001, ISO 13485 and GMP Cell culture systems for research onactivesubstances(bioassays,preclinicalresearch,forqualitycontrol),developmentandproductionofanti-body-based detection systems (ELISA), chemosensitivity assay for optimization of chemotherapy (tumorpatients).

celltrend.de

Chemicell GmbH

Chemicelldevelopsandproducesmagnetic,fluorescentandcolorednano-andmicroparticles,reactivefluo-rescentdyesandspecialchromatography-materialsfortheseparationordetectionofcells,bacteria,viruses,proteinsorDNA/RNAandnewgenetransfersystems.

chemicell.com

Chipron GmbH

ChipronGmbHspecializes inproductionanddistributionofarraybaseddetectionsystemsforDNA/patho-gens.

chipron.com

CMZ-Assay GmbH

Marketing of diagnostic reagents formeasuring concentrations of proteins, hormones and their isoforms,exclusivelyforresearchpurposes.

cmz-assay.com

CONGEN Biotechnologie GmbH

CONGENisspecializedinfoodtestingbymolecularanalyticsbasedonDNAandRNAdetection.CONGENhasbeenapioneerforoveradecadeinthedevelopmentandapplicationoffoodandfeedanalyticsbyreal-timePCR.Themethodsareavailableascompleteanalytickitaswellasaservice.Ourmissionistoservethefoodindustrywithanexcellentserviceandwithstandardizedandreliabletestkitsinordertorealizehighestpossiblefoodsafetyandfoodquality.

congen.de

31DirectoryofRegionalPlayers

cpo - cellular phenomics & oncology Berlin-Buch GmbH

cpoisastate-of-the-artinvitroserviceprovideraimedatofferinghigh-quality,reasonablepricedcellculturemodelscomplementingclassicalinvivoassaysusingpatient-derived3Dcellcultures.Weviewourselvesaspartnerswithourcustomers,ouremployees,ourscientificcommunityandourenvironment.Ourmissionistohelpthebiotechandpharmaindustriescreateinnovativetestingsofnovelanti-cancerdrugs.

cpo.berlin

Diaglobal GmbH

Development,productionanddistributionofinvitrodiagnosticsforanalyticalpurposesandthedistributionofmedicalproducts.

diaglobal.de

Dr. Götz Verfahrenstechnik Biotechnik Umwelttechnik

Contractresearchandcontractmanufacturingusingbacteria,yeastsandfungi. drgoetz.de

Dr. Lerche KG

Innovative companyengaged in development, production andmarketing of specializedmicrocapsules forbio-andmedical technology -DevelopmentandproductionofnovelDNA-Purification-Kitswithproprietarytechnology-Productionandmarketingofmicrocapsules(LUMiTainer),microbeadsandcellbasedsedimen-tationstandardsforbloodanalysis(Sedi-ValESRstandards)-Encapsulationofcells-Contractanalysisforcharacterizationofmicrocapsules,porousmembranesandhollowfibres.

lerche-biotec.com

Dr. Rölleke Labor für Genetische Analytik GmbH

Dr.Roellekeisspecializedintheidentificationofmicroorganisms,particularlyintheareaoffoodsafety.Fur-thermore,Dr.Roellekeisauthorizedexpertonpaternitytestsforcourtsandtheprivatesector.

dr-roelleke.de

E.R.D.E.-AAK-Diagnostik GmbH

E.R.D.E.-AAK-DiagnostikGmbHisalaboratorythatoffersantibodytestingforcommercialpurposes. aak-diagnostik.de

EMP Biotech GmbH

Productionoffluorescentdyesandchemiluminescentreagents.Contractchemicalsynthesisofsmallmole-cules.Contractlabelingandpurificationofproteins,antibodiesandoligonucleotides.Productionofsize-exclu-siongels,columnsandfilterplates.ProductionofhighqualityreagentsforDNAsynthesis.

empbiotech.com

Epigenomics AG

DevelopmentandcommercializationofinnovativemoleculardiagnostictestproductsbasedonDNAmethyla-tionforcancerscreeningandforcancerspecialtyapplications.

epigenomics.com

Epiontis GmbH

Establishingmethylation fingerprinting asGoldStandard for quality control inRegenerativeMedicine andImmunomonitoring.

epiontis.com

Eurovir Hygiene-Institut/Dr. Thraenhart

Laboratoryservicefortestingtheefficiencyofproductsagainstviruses(virucides)andofprocessesforinac-tivatingoreliminatingviruses(virussafety).

eurovir.de

FILT Lungen- und Thoraxdiagnostik GmbH

Developmentofinnovative,non-invasivediagnosticmethodsintheareaofrespiratorydiseasesandallergies. filt.de

GA Generic Assays GmbH

Development,manufacturing and international distribution of in vitro tests including tissue and cell-basedIFA,DotandELISAassaysforthediagnosisofrheumaticandotherautoimmunediseaseswithneurologic,vascular,hepatic,renalorgastrointestinalorigin.PatentholderofCytoBead®assay,aone-stepdiagnostictoolcombiningcell/tissue-basedimmunofluorescenceassayforthescreeningandmicroparticle-basedmultiplexassayforthedifferentiationandconfirmationofautoimmunediseases.

genericassays

GenExpress Gesellschaft für Proteindesign GmbH

GenExpressisaflexiblecompanyprovidingservicesinmolecularbiology.Foroveradecadewehavesuc-cessfullyworkedforcustomersinclinicallaboratories,researchinstitutionsandtheindustry.WeoffercloningofPCRtargets,preparationofsyntheticgenes,expressionofproteins,evaluationofLightCycler®assays,fur-thermoreproductionofinternalcontrolsandstandardsforRealTimePCRsystems,alsocloning,expressionandpurificationofproteins.

genexpress.de

GILUPI GmbH

GILUPIisamedicaldiagnosticscompanywithaninitialfocusontheprenatalandcancermarket.Thecom-pany is developing an innovative newdiagnostic product based on nanotechnology.Our goal is to catchspecificcells,whichcanbefoundonlyinverylowconcentrationintheblood.Thefirstapplicationforournewnanosensordevicewillbeprenataldiagnosesofchromosomalaberrationoutofmaternalblood.Thesecondapplicationwillfocusontheearlydiagnosisofcancer.

gilupi.com

32 DirectoryofRegionalPlayers

Glycon Biochemicals GmbH

GlyconBiochemicalsisaspecialistinthefieldofcarbohydratechemistry,ionicandnonioniccarbohydratedetergents,firstofallanomericpuren-Dodecylß-maltosideandbuildingunitsusedforthesynthesisofnewpharmaceuticalcompoundsanddiagnostics.

glycon.de

HealthTwiSt GmbH

HealthTwiStisaserviceproviderfor“GeneticContractResearch”inthefieldsofFunctionalGenomics,Epi-genetics,ProteomicsorFunctionalFood/Nutriceuticals.Inparticular,HealthTwiStisofferingaccesstoexten-sivelycharacterizedhumansubjectsandsamplesaswellasprospectivestudiesintwins,togetherwithknow-howintheanalysisofcomplexgenetictraits.Furthermore,databasedevelopment,datamanagementandstatisticalanalysesforclinicalprojectsareprovided.

healthtwist.de

Histalim

Fornearly10yearsHISTALIMprovidesservicesinthefieldsofhistology,cytologyandmolecularbiologyforclientsfromawiderangeofsectorsincludinghumanandanimalhealth,dermo-cosmetics,chemistry,environ-ment,agronomics,agri-foodindustry

histalim.com

hospital Laborverbund Brandenburg-Berlin

ThehospitallaboratorycompositeBrandenburg-Berlin,basedinBerlin,employsapproximately100employ-eesat5locations.Morethan4milliontestsarecarriedoutwithatotalof2,000differentanalyticalproceduresannually.Thegoalisaninexpensive,fastandhigh-qualitylaboratorydiagnostics.

hospital-laborverbund.de

Hybrotec GmbH

HybrotecGmbHisspecializedinthedevelopmentofmonoclonalantibodiesandimmunoassays(preferablyhomogenousassays)ascustomsservice.Ourmainfocus liesonantibodiesbinding lowmolecularweightsubstances(e.g.toxins,fluorophores,hormones)aswellasantibodiesagainstnovelproteins.

hybrotec.com

Ifp Institut für Produktqualität GmbH

IfpInstitutfürProduktqualitätisalaboratoryandcompetencecentreforstate-of-the-artfood,drinkingwaterandpharmaceuticalanalysis.TheaccreditedandGMP-certifiedcompanyfocusesoncomprehensiveservicesforthefoodandpharmaindustry.Anadditionalcorecompetenceofifpisthedevelopmentandproductionofinnovativediagnosticscomprisingthereal-timePCRkitsofthebrand“mericon”(QIAGEN),vitamintestsinmicrotiterplateformat,enzymaticmicrotiterplatekitsforsugars/acids,andallergentestsinlateralflowandELISAformats.

produktqualitaet.com

IKDT Institut Kardiale Diagnostik und Therapie GmbH

IKDTwasfoundedinAugust2002inBerlin-SteglitzandisoneoftheleadinglaboratoriesonViralInfectionsofHeartMuscleTissueandDilatatedCardiomyopathy(DCM)inGermany.IKDTlabisperformingacomprehen-sivemoleculardiagnosticexaminationofendomyocardialbiopsiesasoneofalimitednumberofspecializedcardiological labsworldwide. Itsserviceenablesphysiciansfirstly tostartanefficient,pathophysiologicallybasedcausaltherapy.

ikdt.de

ILBC GmbH

Research,consulting,production,trade&servicesintheareasbiology,molecularbiologyandproteinchem-istry-Expressionandproductionofantimicrobialpeptides.

mobiclup.de

In.vent DIAGNOSTICA GmbH

in.ventDIAGNOSTICAGMBHisabiomedicalcompany.Wearefocusedontheproject-orientedprovision,processing and distribution of biological rawmaterial for development and production of diagnostics andcontrolmaterial.Weareyourreliablepartnerforthecustomiseddevelopmentofassaysformedicalinvitrodiagnostics.

inventdiagnostica.de

Innovative Optische Meßtechnik GmbH

FluorescenceAssaySolutionsandInstrumentation(MicroplateReaders). iom-berlin.de

Institut für Medizinische Molekulardiagnostik (IMMD) GmbH

Genetestsforprenatal,predictiveandtumor-diagnostics. immd.de

InVivo Biotech Services GmbH

InVivoisacontractmanufacturingorganization(CMO)dedicatedtothedevelopmentandproductionofmono-clonalantibodiesandexpressionofrecombinantproteinsforresearch,diagnosticandpre-clinicaluse.Inthelast19yearsmorethan3000monoclonalantibodieswereproducedondemandforcustomersoftheIVDorpharmaindustryinanyscale.RegardingimmunoassaydevelopmentInVivocoverseveryaspectofthewholevaluechain.FromantigenproductionviatransientgenetransfectioninHEKcellstoCEapprovalofthefinaltestInVivomanufacturesondemandandprovidesadviceandsupport.

invivo.de

33DirectoryofRegionalPlayers

JPT Peptide Technologies GmbH

JPTPeptideTechnologiesGmbHistheleadingproviderofinnovativepeptide-basedservicesandproducts,aswellasapartnerforR&Dprojectsinimmunotherapy,proteomicsanddrugdiscovery.

jpt.com

Kairos GmbH - Berlin

KairosisarenownedIT-specialist,whichlooksbackonmorethan10yearsofexperienceinthedevelopmentofIT-systemsolutionsforthehealthcare.Inadditiontotechnologicalspecialknowledgeintheimplementa-tionofmedicalmiddlewareplatforms,wehaveextensiveknow-howintheIT-supportedorchestrationofworkprocessesviaworkflowengine.

kairos.us

KNAUER - Wissenschaftliche Gerätebau Dr. Ing. Herbert Knauer GmbH

KNAUERUHPLCandHPLCsystemsaswellascolumnsareusedinresearchanddevelopment,qualitycon-trolandproductionplantlaboratoriesaroundtheworld.Customersaretypicallygovernmentalandindustrialorganizationsaswellasuniversities.Fieldsofapplicationarewide-rangingandincludepharmaceuticalandmedicalresearch,analysisoffoodstuffsandcosmetics,aswellasenvironmentalanalysis.Withourbiochro-matographysolutionswefocusonhighresolutionseparations.

knauer.net

L.U.M. Gesellschaft für Labor-, Umweltdiagnostik & Medizintechnik mbH

Analysis,diagnosisandsensortechnologyaswellasstability,rheologyandsegregationbehaviorofdisper-sions.

lum-gmbh.de

Labor Berlin – Charité Vivantes Services GmbH Labor Berlin – Charité Vivantes GmbH

LaborBerlin–CharitéVivantesGmbHLaborBerlinServices is theservicesubsidiaryofEurope’s largesthospital laboratory forclinicalpathology. Itofferscompletesolutions foranykindof testing in the IVDandpharmaceuticalindustries,CROS,lifesciencecompanies,andotherresearchfacilities.LaborBerlinitselfistheexclusivelaboratorypartnerofCharité-UniversitätsmedizinBerlinandtheVivantesNetworkforHealth.LaborBerlinandLaborBerlinServicescombinedperformover40millionanalysesinclinicalpathologyeachyearandprovidediagnosticservicesforover400,000in-housepatientseverydayaswellasmorethanonemillionout-patientseachyear.

laborberlin.com

LGC Genomics GmbH

LGCGenomicsisthedivisionofLGCwithspecificexpertiseinhighquality,cutting-edgegenomicandrelatedservices and products. LGCGenomics delivers: Next generation sequencing services. DNA sequencing.Genomicsservices.NucleicacidextractionservicesDNAextractionproducts.LGC isan internationalsci-ence-basedcompanyandmarketleaderinanalytical,forensicanddiagnosticservicesandreferencestan-dards(www.lgc.co.uk).

lgcgenomics.com

LGC GmbH

Productionofcalibrationsubstancesforpuritytestingofdrugs. mikromol.de

Limetec Biotechnologies GmbH

Thecorecompetenceliesinthedevelopmentofhigh-speedandhigh-qualityproofsystemsforthedetectionofpathogens,aswellasintheallelicdiscriminationofhereditarydiseases.AllproductsaremarkedwiththeCE-Certificate.Thesecondareaofexpertiseisthecreationofcommunicationnetworkswhichconnectout-pa-tientandhospitalpatienttreatments,intensifydataexchangeandprovideinformationtoallhealthinstitutions,thusestablishingpartnerrelationshipsbetweenthem.

limetec-biotechnologies.de

Lipidomix GmbH

LC/MS/MSbasedhighthrouputanalyticoflipidmediatorsandmetabolites.Analyticalmethoddevelopment,analyticalsupportforLC/MS/MSinlifescience,foodsafety,forensicscience.

lipidomix.de

MedInnovation GmbH

MedInnovationGmbHhasdevelopedanewmethodanda specialESR-analyser,which for the first timeallows a simple routine laboratory test for evaluation of functional characteristics of plasma proteins andfurtheropensareliablepossibilityforcancerdiagnostic,namedMMS-technology(mobilityofmolecularstruc-ture).

medinnovation.de

Medipan GmbH

Development,manufacturingandinternationaldistributionofradioactive(RIA)andnon-radioactive(ELISA)in-vitrodiagnostic tests,covering thefieldofautoimmunity,mainly thyroidautoimmunityand type1diabe-tes.InventionandworldwidedistributionoftheAKLIDES®system,aplatformtechnologyfortheautomatedinterpretationofcellandbead-basedimmunofluorescenceassays.AnewapplicationisthedetectionofDNAdamagecausedbyradiation,oxidativestressordrugs.

medipan.de

Metabolomic Discoveries GmbH

MetabolomicDiscoveries is an analytical service and research company.We providemass spectrometrybasedmetaboliteprofilingandfingerprintingofbiologicalmaterial,aswellassinglecompoundmeasurements.

metabolomicdiscoveries.com

34 DirectoryofRegionalPlayers

Metanomics GmbH

MetaboliteProfilingforidentificationofgenefunctionrelationshipinplants,metabolitebiomarkersandmeta-bolic networks.

metanomics.de

Metanomics Health GmbH

MetanomicsHealthGmbHisacompanyspecializinginthescientificareaofmetabolomics.Itsresearchtar-getstheidentificationofmetabolicbiomarkersforpharmacology,nutritionanddiagnostics.Thecompanyrunsitsownclinicalbiomarkerprogramaimingatdiseaseusecaseswithhighunmetmedicalneed,e.g.theearlydetectionofpancreaticcancerandheartfailure.WithitsMxP®QualityControlPlasmaproductthecompanyisenablingpreanalyticalqualitycontrolofbiospecimen.

metanomics-health.de

Mfd Diagnostics GmbH

ThemfdDiagnosticsGmbH(BTLuckenwalde)isalifescienceresearchanddevelopmentcompanyfordiag-nosticandtherapeuticapplicationof innovativelasertechnologies.Themainadvantagesofthedevelopedtechnologiesarethenon-/minimally-invasivemeasurementmethods,thenon-artificialapproachandthepos-sibilityofreal-timemeasurement.Therefore,thosearepromisingtoolsforthediagnosisandtherapymonitor-ingintheneurologicalpracticeandintheperinatalsurveillance.

mfd-diagnostics.com

MicroDiscovery GmbH

MicroDiscoveryGmbH isa leadingproviderofhighquality software forbiomolecular research, innovativediagnosticsandpersonalisedmedicine.Thecompany is ISO9001certifiedandhasastrong track recordincreatingsoftwaresystems inaccordancewithrelevant regulatorydirectives for the lifescienceand IVDindustry.CustomisedservicesrangingfrombiostatisticaldataanalysistobioinformaticaldesignandsupportofcomplexresearchprojectscompletetheproductlineofMicroDiscovery.

microdiscovery.de

Minerva Analytix GmbH

MinervaAnalytixGmbHisaleadinganalyticalservicelabforthecontrolofmicrobialcontamination.Ourcorecompetenceliesinthecontrolofmycoplasma,bacteriaandvirusesincellculturesandbiopharmaceuticals

minerva-analytix.com

Minerva Biolabs GmbH

MinervaBiolabsisdevelopingandmanufacturingmoleculardiagnosticreagentsforcontaminationcontrolinacademicresearchlabsandbiopharmaceuticalindustry.WeemploykitsandreagentsforbasicPCRwork,mycoplasmaassaysandcellculturecontaminationpreventionreagents,microbialdetectionassaysinfoodandwater,meatidentificationassays,halal-andvegan-confirmationassaysforprofessionalqualitycontroltestinglabs.Inaddition,wearebusyascontractmanufacturer(CMO)specializedinthedesignandproductionofmolecularbiologicalreagents,PCRassaysandsamplepreparationkitsaccordingtoDINENISO13485.

minerva-biolabs.com

MLB Mikrobiologisches Labor GmbH

Accreditedtestlaboratoryfordrinkingwater,cleanrooms,sterility,bioburdens,D-PL-13398-01-00,EN17025.Accreditation according to VDI 6022.

mikroberlin.de

Molnar-Institut für angewandte Chromatographie

Molnar-Institute,establishedin1981,offersyouacompletescientificandtechnicalserviceforallproblemsconcerningQuality byDesign (QbD) for HPLC-methods.We develop for you theDesign Space for yourHPLC-separation and establish Critical QualityAttributes (CQA’s).We offer detailed DryLab-courses andshowyou,howtodeveloprobustmethodsintheDesignSpaceandhowtosavetime.Wesupplyandimple-menttheDryLab-softwareandtrainyourcoworkers.Weassistyouinautomatedmethoddevelopmentpro-cessesandsupportyouintheselectionofproperinstruments,theirinstallationanduse.

molnar-institute.com

moloX GmbH

moloXGmbH isacompany focusingoncustomproteinproduction inbacterialand insectcellexpressionsystems and subsequent protein purification to ultra-high purity.On customer demand a teamof expertscanperformproteincrystallizationexperimentsanddetermine the3Dstructureof targetproteinsbyX-raycrystallography.

molox.de

Nano Access Technologies Ltd.

Thecompanyaddressesthecombinedaccesstokeytechnologiessuchaslifescienceandnanotechnology.Asafirstproduct,alowcostAFMforoperationwithso-calledactivecantilevershasbeendeveloped.Besidesthis,functionalizedcantileversforfuturebiosensorsareanotherfocusofthecompany.

nano-access.com

Nanolytics Gesellschaft für Kolloidanalytik mbH

Weareacontractlaboratoryspecializinginthephysico-chemicalcharacterizationofpharmaceuticalproteins,biopolymers,nanoparticlesandcolloidalsystems.Ourcore-competencesareAnalyticalUltracentrifugation,incombinationwithStaticandDynamicLightScatteringaswellasspectroscopic (CD,fluorescence)andthermodynamictechniques(ITC,DSC).

nanolytics.de

35DirectoryofRegionalPlayers

neweramabs

new/era/mabsGmbHprovidesall-roundsolutionsforthegenerationandcharacterizationofmurine,camelidandhumanantibodies.Thecompanyoffersahighlyeffectiveimmunizationandselectionplatforminordertocombineantibodygenerationwithaveryearlyvalidationdirectlyafterfusion.Foundedin2014byKatjaHanackandPamelaHolzlöhner,thecompany-ownershaveovertenyearsofexperienceinantibodydevel-opment,validationandassaydevelopment.Withaworld-widepatent-pendingsystemwearenowlookingforreliableandcompetentbusinesspartnerstomarketourplatform.

neweramabs.com

OakLabs GmbH

OakLabsprovides themostflexibleproductsandservices for largescalecustomSNPgenotypingon themarket.OakLabsoffersseveralformatsforanalysingavariablenumberofSNPsinanysequencedorganism.

oak-labs.com

OpTricon Entwicklungsgesellschaft für optische Technologien mbH

OpTricon develops and produces mobile readers for quantitative analyzes of immunoassays forPoint-of-Care-diagnostics,especiallyLateralFlowAssays(LFA).Additionalbusinesssegmentsarecompo-nentsandsystems forsignal transmissionandsensors forbioanalytics.opTricondevelops thedevices in partnershipwith the customers andworks asOEM-supplier and is certified byTÜVRheinland accordingENISO13485:2003+AC:2007andENISO9001:2008.

optricon.de

ovalehn GmbH

ProductionandapplicationofspecificrecipescontainingIgYfordiagnosticsandoral,passiveimmunetherapy. ovalehn.de

Peptides&elephants GmbH

Customsynthesisofpeptidesandpeptidelibraries,developmentofparallelsynthesistechnologies,distributorofpeptidesynthesisautomation.

peptides.de

PolyAn, Gesellschaft zur Herstellung von Polymeren für spezielle Anwendungen und Analytik mbH

PolyAn is specialised in Molecular Surface Engineering (MSE). Using our surfacemodification expertisePolyAnoptimisestheperformanceofanalyticalsystemsbyimprovingthesignal-to-noiseratioaswellasthereproducibilityof consumables formultiplexdiagnostics,LifeScience researchandscreeningapplications.PolyAn’sproductportfolioincludesfunctionalisedmicroarrayslides,microparticlesformultiplexbeadarraysandfunctionalisedmembranesformedicaldiagnosticapplications.

poly-an.de

Preclinics Gesellschaft für präklinische Forschung mbH

Preclinics is a commercial cooperation partner for preclinical research and development. As a competent, cre-ativeandexperiencedpartnerpreclinicsinvestigatespharmaceuticalsubstances,therapeuticmethodsandproceedingsaswellasmedicalproductsduringthepreclinicalphase.Additionalweprovidecustomantibodyproductioninlama,goat,sheep,rabbitandotherspecies.

preclinics.com

Predemtec GmbH

PredemtecGmbHisacompanyfocusedontheresearch,developmentandmanufactureofinnovativediag-nostictestsforuseinthedetectionofdementia-relatedriskfactors.Thegoalhasbeentomaketheearlyandreliablediagnosisofvariousdementia-relatedillnessesarealitythroughtheuseofourinnovativediagnosticstests.

predemtecDX.com

PROTEKUM - Umweltinstitut GmbH, Oranienburg

Weplantoeliminatefluidandsolidwasteproductsinamannerwhichiscompatiblewithenvironmentpro-tection.Ourmethodologyislargelybasedonpainstakinganalysis.Weusemodernequipmentandscientificmethods.Protekumoffershigh-qualityproductsandservicesinenvironmentalanalysisredevelopment.

protekum.de

Proteome Factory AG

Biomarker&targetdiscovery,validation,analysisoffoodandingredients,absolutequantificationofproteinsandpeptides, sequencingandcharacterizationofproteinsandantibodies (CDR),2DEandLC-MSbasedproteomicsstudies,pharmacokinetics,pharmaco,immunoandmembraneproteomics,proteinidentification,characterizationofproteinsandpeptides (PTMs,e.g.phosphorylation,glycosilation),qualitycontrol,massdetermination,N-terminalaminoacidsequencing,silverstainingkitetc.

proteomefactory.com

Provitro GmbH

Provitrocombinesmorethantenyearsofexperiencesincommercialisationofcellculturetechnologies,Tis-sueMicroarraysandimmunohistochemicalanalyseswiththescientificexpertiseofthePathologicalInstituteoftheCharité,Berlin.BasedonaqualitymanagementsystemaccordingtoISO9001:2008,weprovideourcustomersnotonlywithhigh-qualityproducts,CEmarkedinvitrodiagnosticsandstate-of-the-artservicesbutalsowithindividualsolutionsfortheirspecificrequests.

provitro.de

RENESA UG

Manufacturinganddistributionofrapidtests,mainlyformedicalpurposes(PointofCareTesting). renesa.de

36 DirectoryofRegionalPlayers

RIPAC-LABOR GmbH

RIPAC-LABORoffershigh-qualitydiagnosesofbacterialinfections,particularlyinpoultry,pigsandcattle,butalso inotherfarmanddomesticanimals.Thecompanyusespathogendifferentiationtoprovidequickandeffectivemethodsforfightingpathogens.Itperformsresistancetestsandepidemiologicalanalysesandalsofocusesonproducingherd-specificvaccines.

ripac-labor.de

Roboklon GmbH

Distribution,marketinganddevelopmentofproductsformolecularbiologicalresearchandgeneticengineer-ing.

roboklon.de

Scienion AG

Scienion is a leading solution provider in themarkets of precision dispensing and diagnostics solutions.The product portfolio comprises hardware, consumables and services. Scienion’s leading product is the sciFLEXARRAYERnon-contactdispensingsystem,availableindifferentversionsforR&Dandmanufacturingpurposes. It represents theperfect tool forautomatedultra-lowvolume liquidhandlingofvarious typesofsamples.Thecompanyhasawide-rangedexperienceindevelopingmicroarraysfornumerousapplications,includingglycan-basedassays,e.g.forthedetectionofHeparin-inducedthrombocytopenia,alife-threateningprothrombotic condition.

scienion.de

selekt-ID BIOLABS GmbH

Theselekt IDBiolabs isamolecularbiologyservice laboratory.Theportfolio includesseveralPCR-basedtechniques detectionmethods:The core product is the identification ofmicroorganisms (bacteria, yeasts,fungi)bysequencecomparisonof16Srespectively.Willalsoofferthedetectionofanimalspeciesinmeatproductsand,asGMOanalysisanddetectionofallergens.

selekt-id.de

Sepiatec GmbH

Production,developmentandsalesofautomatedHPLCmachinesforhigh-throughputpurificationandfrac-tioningofcomplexsubstancecompounds.

sepiatec.com

Seramun Diagnostica GmbH

Seramunofferspeptidesynthesis,purificationandconjugationofproteins,productionofantibodies,customerresearch, invitrodiagnostics.Wefocusonthedevelopmentandproductionofenzymeimmunoassaysfordiagnosisofviralandbacterial infectionsandautoimmunediseasesofthegastrointestinaltract,thedevel-opmentofmulti-parameterassaysasmicrotitreplateassaysandasmembraneimmunoassays,aswellasdevelopmentofready-to-usesubstratesolutionsandforproteinstabilizers.

seramun.com

sifin diagnostics gmbh

Ourcompanyismanufacturinganddistributingworldwideabroadrangeofmicrobiologicalandimmunologicalproducts: bacteriological test reagents, bloodgrouping serological products, dehydratedand ready-to-useculturemedia.Wedoalsoofferalargevarietyofmonoclonalantibodiesandareopentodevelopandproducetocustomers’specifications in ready-to-use,concentrateorbulk format.MICRONAUT is the trademarkofMERLIN’sproductlineforautomatedmicrobialidentificationandantimicrobialsusceptibilitytesting(AST)ofclinicallyrelevantbacteriaandyeasts.Itisexclusivelyavailableatsifindiagnosticsgmbh.

sifin.de

Signature Diagnostics AG

SignatureDiagnosticsisdedicatedtothediscovery,validationandcommercialdevelopmentofnoveldiagnos-ticproductsthatpredictoutcomeanddrugresponseinpatientswithcolorectalcancer(CRC),non-smallcelllungcancer(NSCLC)andovariancancer.Signaturebelievesthatpatientselectionandstratificationbasedonmoleculargenesignatureswillsoonbecomeanimportantcomponentofroutinecancertreatment.

signature-diagnostics.de

SLM- Speziallabor für angewandte Mikrobiologie GmbH

Microbiological quality control for medical devices, pharmaceuticals, cosmetics, drinking water, foodstuff,monitoring in clean rooms.

speziallabor.com

STRATEC Molecular GmbH

STRATECMolecularGmbHisagloballyactiveproviderofinnovativesystemsolutionsfornucleicacidsamplecollection,stabilization,andbothmanualandautomatedpurificationfromanysampletype.Since1992thecompanyisinternationallyrespectedforitsoutstandingandhighperformancetechnologyplatformsandoffersabroadspectrumofsuperiorproductsformoleculardiagnostics,drugdiscoveryandLifeScienceresearch.

invitek.de

Surflay Nanotec GmbH

SurflayNanotecGmbH,isspecializedoncoatingcolloidalandplanarmaterialswithfunctionalfilmsofnano-meterthickness.KeytechnologyistheLayer-by-Layer-Technologywithfunctionalizedpolymers.Applicationsareinthefieldsofbio-sensingbyWhisperingGalleryModes,separationmaterials,pigmentencapsulation,anddiagnosticparticles.InadditiontocustomertailoredprojectsSurflayoffersanuniquerangeofproductsoffunctionalmonodispersemicroparticles,microsensorsanddye-labeledpolymers.

surflay.com

37DirectoryofRegionalPlayers

Targenomix GmbH

TargenomixGmbHisastartupcompanywithcorecompetencesincomputationalandsystemsbiology,quan-titativeandmoleculargenetics,cellbiologyandbiochemistry.Oneofthemainresearchfieldsistheidentifica-tionofinteractionsbetweenmoleculartargetsandsmallmolecules.

targenomix.com

Thanares GmbH

Development,useandmarketingofanalyticalprocessfordiagnosticandtherapeuticpurposes.Futurebusi-ness activities: detection process for bioactive substances in bodily fluids, isolation, characterization andinvestigationof bioactive compounds fromplants, in particular insoluble proteins or low concentrationsofproteins,developmentoflowcostgeneticsystemsforover-expressionand/orproductionofsuchproteins.

thanares.com

Thermo Fisher Scientific – B·R·A·H·M·S GmbH

ThermoScientificBiomarkers(B·R·A·H·M·SGmbH)explores,developsandproducesnewdiagnostic testprocedurestoimprovethediagnosis,andtherebythetreatment,oflife-threateningillnesses.Thistakesplacewithover470employees,inthediseaseareasinfectiology,cardiologyandpneumologyaswellasthyroid,autoimmunityandcardiologyonthebasisofourownpatentedbiomarkers.SinceOctober2009B·R·A·H·M·SGmbHispartofThermoFisherScientificInc.(NYSE:TMO),theworldleaderinservingscience.

thermoscientific.com/brahms

TIB MOLBIOL Syntheselabor GmbH

In1990,TIBMOLBIOLbecamethefirstGermanmanufacturerofoligonucleotides.InadditiontodesigningandsynthesizingprimersandprobesforReal-TimePCRassays,wedevelopandproduceLightMix® Kits for RocheDiagnosticsLightCycler®Instruments,coveringapplicationsinclinicalchemistry,pharmacogenetics,pathogendetection,aswellascancerresearch.TIBMOLBIOLisISO13485andISO9001certified.

tib-molbiol.com

UGA Biopharma GmbH

UGABiopharmaaprivateresearchanddevelopmentcompany,focusesonresearch,developmentandcom-mercializationofbiopharmaceuticalproductsundercontractwithotherbiopharmaceuticalcompanies.UGABiopharmaconductspowerofbiosciencestodevelophigh-tech, lastgenerationofbiomedicine,diagnostickits,molecularbiologyitemsandalsooffersworldclassservicesinbiotechnologyarea.

ugabiopharma.com

Yashraj Biotechnology GmbH

Yashraj Biotechnology Limited (YBL) is a part of the “YASHRAJ GROUP” having diversified interests in finance,construction,agriculture,chemicalsandbiotechnology.YBLwasestablishedin1999withamissiontoachieveexcellenceinbiotechnologyandutilizeitspowerforthegoodofhumanity.

yashraj.com

Zentrum für molekulare Onkologie GmbH

Innovative methods for diagnostic and therapy of tumor diseases – Molecular genetics (K-RAS, PCA3,Septin9,...)–Chemoresistanceassayforpredictionofchemotherapy–Pathologydevelopmentofnewbio-markersandanalyticalservicesforstudies.

molekulare-onkologie.eu

Zytomed Systems GmbH

ZytomedSystems´focusisthedevelopment,productionanddistributionofantibodiesanddetectionsystemsforimmunohistochemicalcancerdiagnosticsaswellasreagentsandkitsforin-situhybridisation.

zytomed-systems.de

38 DirectoryofRegionalPlayers

Universities and Research Institutions

BAM Federal Institute for Materials Research and Testing bam.de

Berlin Institute of Health bihealth.org

BfR Federal Institute for Risk Assessment bfr.bund.de

Brandenburg University of Technology tu-cottbus.de

Charité - Universitätsmedizin Berlin charite.de

German Rheumatism Research Center Berlin drfz.de

Fraunhofer Institute for Applied Polymer Research IAP iap.fraunhofer.de

Fraunhofer Institute for Cell Therapy and Immunology - Bioanalytics and Bioprocesses IZI-BB izi.fraunhofer.de

Fraunhofer Institute for Reliability and Microintegration IZM izm.fraunhofer.de

Freie Universität Berlin fu-berlin.de

German Heart Institute Berlin dhzb.de

German Institute of Human Nutrition (DIfE) dife.de

Hasso Plattner Institute for Software Systems Engineering hpi.de

Humboldt-Universität zu Berlin hu-berlin.de

Institute for Thin Film and Microsensoric Technologies (IDM) idm-teltow.de

Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) leibniz-fmp.de

Leibniz-Institut für Analytische Wissenschaften - ISAS - e.V. isas.de

Leibniz-Institut für innovative Mikroelektronik ihp-microelectronics.com

Max Delbrück Center for Molecular Medicine (MDC) Berlin-Buch mdc-berlin.de

Max Planck Institute for Colloids and Interfaces mpikg.mpg.de

Max Planck Institute for Infection Biology mpiib-berlin.mpg.de

Max Planck Institute for Molecular Genetics molgen.mpg.de

Brandenburg Medical School Theodor Fontane mhb-fontane.de

Physikalisch-Technische Bundesanstalt (PTB); Germany's national metrology institute ptb.de

Robert Koch Institute (RKI) rki.de

Technische Universität Berlin (TU) tu-berlin.de

University of Applied Sciences Wildau tfh-wildau.de

University of Potsdam uni-potsdam.de

Weierstrass Institute for Applied Analysis and Stochastics wias-berlin.de

Publisher: BerlinPartnerforBusinessandTechnologyincooperationwiththeBran-denburgEconomicDevelopmentCorporation (WFBB), commissionedbythe Berlin State Senate Department for Economics, Energy and PublicEnterprisesandtheBrandenburgStateMinistryforEconomicAffairsandEnergy.FundedbytheStateofBerlinandtheStateofBrandenburgaswellastheInvestitionsbankBerlin,cofundedbytheEuropeanUnion–Europe-anRegionalDevelopmentFund.

EUROPEAN UNION

European Regional Development Fund

BerlinPartnerfürWirtschaftundTechnologieGmbHFasanenstraße8510623 BerlinGermanyPhone+493046302-500info@healthcapital.dewww.healthcapital.de

Author:AlmutGebhard,StrategischeKommunikation

Design:Marc Mendelson

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©November2017

39 Imprint

Berlin Partner für Wirtschaft und Technologie GmbHFasanenstr. 8510623 BerlinGermanywww.berlin-partner.deTwitter:@BerlinPartner

Contact:T+49(0)3046302-463info@healthcapital.de

EUROPEAN UNION

European Regional Development Fund

FundedbytheStateofBerlinandtheStateofBrandenburgaswellastheInvestitionsbank Berlin,cofundedbytheEuropeanUnion– EuropeanRegionalDevelopmentFund.

Ouraim:yoursuccess!TheGermancapitalregionisoneoftheleadinglifesciencesandhealthcareindustriescentersintheworld.Attheinterfacesofbusiness,scienceandclinics,theHealthCapitalclustermanagementsupportsnetworkingandthetechnologytransferandhelpscompaniesinterestedinrelocatingtotheregion.BerlinPartnerforBusinessandTechnologyandtheBrandenburgEconomicDevelopmentCorporation(WFBB)areresponsibleformanagingthecluster.

Ouraimistoprovidecomprehensivesupporttocompaniesandscientificinstitutionsinterestedininwardinvestmentorfurther development in the capital region.

Wearereadytoassistyouwith:

■ Company start-up ■ Location search ■ Funding and financing ■ Technology transfer and

R&D partnerships ■ Cooperating in networks

Reachoutandcontactus!www.healthcapital.de

Wirtschaftsförderung Land Brandenburg GmbHBabelsbergerStraße2114473PotsdamGermanywww.brandenburg-invest.com

Contact:T+49331–73061-250healthcare@wfbb.de

■ Employee recruiting, programs designed to retain skilled specialists and qualification

■ International market development