Biotechpharma company profile
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October, 2012
History
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2004
2012
2007
2004 – Biotechpharma UAB established as a
proteomic research company in Vilnius, Lithuania
2005 – Company became a member of UK’s
Northway group, investing in healthcare and
biotechnology areas
2007 – Biotechpharma established
biopharmaceutical R&D activities and started to
develop recombinant protein technologies
2011 – new biopharmaceutical R&D center was
established to provide contract research services
2012 – cGMP-compliant biopharmaceutical
production facility was constructed
Biotechpharma is a contract services company
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Research and Development
has professionals with 20+ years experience
in biochemistry, biology and bioprocess
engineering
Production
all projects are executed in a state-of-the-art GMP facility by experts with 15+ years
experience in recombinant protein
manufacturing
Quality
our quality system ensures process and
product compliance at all stages of research,
development and commercial
manufacturing.
Business development
our business model is executed with
support of leading international
companies searching for partners and
customers
Facilities
• R&D centre (1320 sq.m. total area):
• 800 sq. m. of GLP laboratories for process development
• Administration and meeting areas
• Production facility (2080 sq.m. total area):
• 700 sq. m. of class D, C and B clean-rooms including QC
• 580 sq. m. utilities area for HVAC, PW, WFI, CS, CA, CW
• 800 sq. m. of warehouses, QA and technical offices
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Integrated R&D and manufacturing services for all stages of biopharmaceutical development
Strain development
Process development
Scale-up Clinical supply Commercial
manufacturing
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R&D services GMP manufacturing services
1320 sq. m. R&D department houses over 800 sq. m. of GLP laboratories for:
• Strain development
• Upstream process development
• Downstream process development
• Biological assay development
• Quantitative/qualitative protein analysis
• Protein structure research
• Process /Protein characterization
2080 sq. m. EU and US cGMP-compliant recombinant protein and final pharmaceutical product manufacturing facility is designed for production of:
• Mammalian cell line or bacteria derived bulk drug substance up to 200 g per batch
• Liquid drug product in vials and pre-filled syringes for clinical supply up to 20.000 units per batch
• Lyophilized drug product up to 2.000 vials per batch
• Commercial manufacturing drug substance and drug product
Process development services
• Development of bacterial and mammalian expression systems
• Establishing and maintaining microbial cell banks
• Development of microbial and mammalian cell-line upstream processes
• Development of downstream processes
• Analytical methods development and validation
• Formulation development
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Equipment: PCR-analyzers, Bioreactors, Bio-analyzers, Electrophoresis equipment, Conventional and 2D chromatography systems, TFF units, UV-VIS spectrophotometers, ESI and MALDI TOF mass spectrometry systems, HPLC units
Strain development
Process development
Scale-up Clinical trial
supply Production
Technology scale-up and GMP manufacturing services
• Technology Transfer
• Pilot manufacturing and scale-up
• Manufacturing of microbial and mammalian derived recombinant proteins
• Drug product F&F development and clinical supply
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cGMP-compliant recombinant protein and final product manufacturing facility is designed for production of:
• Mammalian cell line or bacteria derived bulk drug substance up to 200 g per batch
• Liquid drug product in vials and pre-filled syringes
• Lyophilized drug product
Strain development
Process development
Scale-up Clinical trial
supply Production
Equipment and capacities
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Drug substance manufacturing:
• Microbial bioreactors: 30 and 300 L volume
• Mammalian bioreactors: 5-50 and 200 L volume
• Chromatography systems: up to 3 L/min flow rate
• Harvesting: 20kG continuous centrifuge
• Ultrafiltration/Diafiltration units: up to 5 sq. m.
Drug product Fill and Finish:
• Liquid in vials: up to 20,000 vials per batch
• Freeze dried in vials: up to 2,000 per batch at 1 ml volume
• Pre-filled syringes: up to 20,000 per batch
Strain development
Process development
Scale-up Clinical trial
supply Production
Quality Control
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QC department performs:
• DS/DP/IPC and release testing
• Assays / bioassays validation
• Real time, accelerated and stressed stability studies according to ICH guidelines
• Process validation support testing
– Process related impurities
– Product related impurities
– Buffers mixing/stability
– Cleaning verification/validation QC unit equipment: HPLC, RT-PCR, Capillary electrophoresis, Absorbance plate reader, UV/Vis
spectrophotometer, Analyzer of sub-visible particles in liquids, Automated cell culture analyzer,
Sterility testing equipment, Climatic chambers, Automated titrators, Immunoassays equipment
Strain development
Process development
Scale-up Clinical trial
supply Production
Quality management system
Our Quality management system ensures compliance with EU and US cGMP:
• From early stage development to late stage development and production
• Implemented by following guidance and directives (directive 2001/83/EC, directive 2004/27/EC , directive 2003/94/EC, EU GMP Guide part I and II, ICH Q7 guidance)
• Supported by comprehensive electronic quality management system
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• Documents management
• Training management
• Change control
• Equipment calibration/maintenance
• Deviation control
• Corrective and preventive action
• Out-of-specification/out-of-trend
• Risk assessment and management
Strain development
Process development
Scale-up Clinical trial
supply Production
Biotechpharma’s electronic quality management system covers:
Areas of expertise
• Cell line development and cell banking
• Bacterial, yeast and mammalian expression systems
• High productivity biosynthesis process
• Efficient protein refolding and downstream processes
• cGMP compliant analytical development and stability testing
• Technological audit and process transfer support
• Stable protein formulation development
• Bulk drug substance and drug product cGMP manufacturing
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www.biotechpharma.lt
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