Accelerator Development Services

Providing targeted development and consultation services customized to the needs of your projectOn-Site Technical Support

Consultation Services to Speed Development

Comprehensive Cell Culture Process Development

Instrument Installation and Qualification

Customized Training Programs

USD3079

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Comprehensive Process SupportPall Life Sciences is a leading provider of bioprocess solutions.Our innovative single-use technologies are designed to maximizeproduct quality, optimize manufacturing costs and support bio-process development. To ensure success, all of our products are supported globally by an experienced team of scientists andengineers. From on-site guidance to larger projects in our ownprocess development laboratories, we can help take yourprocess to the next level.

Bioprocess Consulting Services

Skilled cell culture scientists are available both remotely andon-site to assist with process development and optimization.Our broad exposure and experience can help identify criticalareas for process improvement.

Process Development Services

Innovative technologies, modern laboratories, and experiencedscientists combine to help take your process to the next level.Our comprehensive services smooth the learning curve, allowingadoption of advanced methods despite tight timelines.

Qualification Services

Our cell culture technologies are supported on site with thorough services which simplify cGMP compliance. Standard services such as installation, IQ/OQ and training are complemented by custom services to meet the specificneeds of every process.

Streamlining Process Improvement Speed-to-clinic and speed-to-market are often the primary drivers of research timelines. Our customers tell us that sub-optimal processes which can be quickly developed are oftencommercialized, creating long term burdens to supporting futurecampaigns. Opportunities to modernize and shape future projectsare lost when researchers are driven by timeline to developprocesses using dated methods. Pall Process Developmentservices remove the burden of learning curve and provides astreamlined path to the most modern bioreactors and methodsavailable in the market.

The Effect of ExperienceLearning curve and the related experience curve are well studied phenomena which describe the large impact a lack of familiarity can have on overall productivity, quality and speed. Even experienced scientists can feel the impact of these effects when presented with new technologies or methods. Theunknown time required to summit these curves can discourageinnovative approaches during a typical process development. In addition, incorporating a learning curve into a project planreduces resources available for optimization and other necessarytasks. Pall Process Development Services can demystify theadoption of new technologies. Our clear timelines, targetedexpertise and process transfer support allow clients to meetaggressive timelines successfully.

Novel Technologies to Support DiverseApplicationsExperience matters when timelines are tight. Accelerator scientistshave the skills and exposure to bring the latest methods to yourprocess. Clients benefit from this experience through timelinereduction, process efficiency, compliance and future-readiness.With unique bioreactors designed to support both large andunderserved cell culture markets, we have solutions for numerousapplications.

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Key Focus AreasStem Cell Production

Stem Cells (Adipose Derived, Bone Marrow, HepaticProgenitor), Cardiac Lineage Committed Cells

Case Study: Transfer of hepatic progenitor process fromflatware to the Xpansion® multiplate bioreactor in 8 months

Case Study: Transfer of adherent stem cell processes fromflatware to microcarrier-based culture in stirred tankbioreactors

Protein Production

Optimization and scale-up of CHO and baculovirus expression systems

Multiple suspended and adherent cell lines supported

Case Study: A QbD approach for the implementation of a PadReactor® single-use bioreactor

Viral Vaccine and Viral Vector Production

Supporting both human and animal health

Viruses (flu, polio, rabies, herpes, BHV etc.) and viral vectors(adenovirus, AAV, etc)

A549, HEK293, MDBK, Vero, MDCK, MRC5, BHK21, CEF,SF9 cells, etc.

Case Study: linear scalability of virus production in iCELLis®

fixed bed bioreactor in less than nine months.

Case Study: Microcarrier-based Dengue virus expression in Animal component-free media

Microcarrier-based influenza production

Whole-cell, microcarrier-based production of Marek’s vaccine

Targeted Experts for Accelerated TimelinesAn extra hand or access to expert advice during crucial timescan be the difference between meeting project goals and delivering late. Partnering with our team of experts providesextra support when it is needed most.

Global Applications Support

Process development and optimization

Product lifecycle support

Global support and service

Pre-System/Product Delivery Service

Trial support

Customization support

Process feasibility studies

Factory Acceptance Test (FAT)

Installation Support Services

Site Acceptance Test (SAT)

Installation Qualification (IQ)

Operational Qualification (OQ)

Startup assistance and training

Process Optimization

Mixing and cell culture studies

Technology transfer

Yield enhancement

Process scale-up/scale-down

Equipment Maintenance

Warranty and extended warranty

Service and maintenance agreements

Preventative maintenance

Calibration, repairs and troubleshooting

Worldwide SupportOur laboratories are fully equipped with the most current Pall single-use technologies for upstream and downstream processes.Skilled Applications Scientists are available for on-site supportin the Americas from our North American facilities and through-out Europe and Asia from our European facilities.

Westborough, MA, United States

307 m2 of configurable laboratory space

Class 10,000 cleanrooms and BL2-grade suites

Newly designed laboratories with a focus on recombinantprotein and cell therapy processes

Ann Arbor, MI, United States

400 m2 of laboratory space

Three rooms for BL-2 support and one BL-2+area

Focus on adherent microcarrier processes with trainingfacilities for small groups to learn techniques for microcarrierprocess development

Brussels, Belgium

360 m2 of laboratory space

Five BL-2 rooms with the capability to convert to BL-3 as projects require

Focus on cell therapy and viral processes

Portsmouth, United Kingdom

337 m2 of configurable BL2-grade suites

Newly designed laboratories with a focus on innovativemethods for recombinant protein and adherent cell cultureprocesses

Advanced analytics on site including QTOF, H-Class BioUPLC and ForteBio Octet® systems

Customized Service ProposalsWe know that every project is different and there are no standard research problems. Our team carefully evaluates project requirements and develops customized approaches for every proposal. Our five-step process focuses on communication and understanding to ensure success.

Visit us on the Web at www.pall.com/biopharm

E-mail us at bioreactors@pall.com

© 2015, Pall Corporation. Pall, , Fortebio, iCELLis, Octet, PadReactor and Xpansion are trademarks ofPall Corporation. ® indicates a trademark registered in the USA. Filtration.Separation.Solution. is a servicemark of Pall Corporation.

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Corporate HeadquartersPort Washington, NY, USA+1.800.717.7255 toll free (USA)+1.516.484.5400 phonebiopharm@pall.com e-mail

European HeadquartersFribourg, Switzerland+41 (0)26 350 53 00 phoneLifeSciences.EU@pall.com e-mail

Asia-Pacific HeadquartersSingapore+65 6389 6500 phonesgcustomerservice@pall.com e-mail

International OfficesPall Corporation has offices and plants throughout the world in: Argentina, Australia, Austria, Belgium, Brazil,Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, New Zealand, Norway,Philippines, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, UnitedKingdom, and Vietnam. Distributors in all major industrial areas of the world. To locate the Pall office or distributornearest you, visit www.pall.com/contact.

The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly.

DISCUSSION

DEFINITION

APPLICATION

OPTIMIZATION

EDUCATION

Our team is trained to listen. We take the time to collect background knowledge and ensure complete understanding of research objectives.

Each project begins with a translation of existing data and research goals into a detailed proposal which de�nes our planned approach.

At launch, projects are assigned project and technical management. Then research begins in our laboratories or at the customer site.

Experiments build on the last to quickly move to an optimized process. Milestones conclude with collaborative evaluation to plan next steps.

To ensure success, our scientists support transfer of the optimized process through on-site support, training and documentation.