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Biotechpharma company profile
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2014
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 sectors
2007 – Biotechpharma commenced biopharmaceutical R&D activities and started to develop recombinant protein technologies
2011 – new biopharmaceutical R&D center was opened for contract research and development services
2012 – cGMP-compliant biopharmaceutical manufacturing facility was completed
Contract Services Company
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Research and Development
has professionals with 20+ years experience
in biochemistry, biology and bioprocess
engineering
Manufacturing
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
One stop shop from strain development to F&F
Facilities
• R&D centre:
• GLP laboratories for process development
• Administration and meeting areas
• Manufacturing facility :
• GMP Class D, C and B clean-rooms
• QC laboratories, incl. class D, C and B labs
• Utilities area for HVAC, PW, WFI, CS, CA, CW
• Warehouses
• QA and technical offices
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R&D and Manufacturing Services:
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 drug substance and drug product
Process Development Services
• Development of bacterial, yeast 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 supply Manufacturing
Scale-up and GMP Manufacturing Services
• Technology Transfer
• Pilot manufacturing and scale-up
• Manufacturing of microbial and mammalian derived recombinant proteins
• Drug product manufacturing 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 supply Manufacturing
Equipment and Capacities
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Drug substance manufacturing:
• Microbial bioreactors: 30 and 300 L volume wv
• Mammalian bioreactors: 5-50 and 200, 1000 L wv
• 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
• Pre-filled syringes: up to 20,000 per batch
Strain development
Process development
Scale-up Clinical supply manufacturing
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 supply Manufacturing
Quality Management System
Our Quality management system ensures compliance with cGMP:
• From early stage development to late stage development and production
• Implemented by following EU and ICH 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 supply Manufacturing
Biotechpharma’s electronic quality management system covers:
Areas of Expertise
• Bacterial, yeast and mammalian expression systems
• Cell line development and cell banking
• 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
• Drug substance and drug product cGMP manufacturing
• Project Management
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Track record – selected projects for the last 3 years
• BigPharma - technology transfer, process validation and GMP manufacturing of commercial API (E. coli)
• BigPharma - Analytical method development for biosimilar recombinant monoclonal antibodies comparability studies. Drug product formulation development for biosimilar monoclonal antibodies.
• BigPharma - cloning innovative molecule as well as product supply for pre-clinical trials (E. coli)
• US biotech - Human cell line development for neurotoxin bioassay
• US Biotech - process development and material supply for clinical trials of innovative molecule (CHO)
• Worldwide recognized public research university - process development for innovative molecule and material supply for clinical trials (E. coli)
• Asian biotech - development of technology to manufacture blood coagulation cascade related protease (CHO)
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Track record – selected projects for the last 3 years (continued)
• EU biotech - development of technology to manufacture biosimilar monoclonal antibodies (CHO) drug substance as well as drug product
• EU biotech - development and GMP manufacturing of innovative cytokine for Phase I and II (E. coli)
• EU biotech - design and development of half-life extension platform for 2nd generation fusion proteins (E. coli, K. lactis)
• EU biotech - development of technology to manufacture biosimilar recombinant blood factor (CHO, BHK)
• EU biotech - development of cell line for biosimilar MABs (CHO)
• EU biotech – live bacteria manufacturing and lyophilisation (microbial)
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www.biotechpharma.lt
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