Biotechpharma company profile October 2013 1
History 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 services 2004 2007 2012 2012 cgmp-compliant biopharmaceutical manufacturing facility was completed 2
Contract Services Company Research and Development Manufacturing Quality Business has professionals with 20+ years experience in biochemistry, biology and bioprocess engineering all projects are executed in a state-ofthe-art GMP facility by experts with 15+ years experience in recombinant protein manufacturing our quality system ensures process and product compliance at all stages of research, and commercial manufacturing our business model is executed with support of leading international companies searching for partners and customers One stop shop from strain to F&F 3
Facilities R&D centre: GLP laboratories for process 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 4
R&D and Manufacturing Services: Strain Process Scale-up Clinical supply Commercial manufacturing R&D Services GMP Manufacturing Services 1320 sq. m. R&D department houses over 800 sq. m. of GLP laboratories for: Strain Upstream process Downstream process Biological assay 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 5
Process Development Services Strain Process Scale-up Clinical supply Manufacturing 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 and validation Formulation 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 6
Scale-up and GMP Manufacturing Services Strain Process Scale-up Clinical supply Manufacturing Technology Transfer Pilot manufacturing and scale-up Manufacturing of microbial and mammalian derived recombinant proteins Drug product manufacturing and clinical supply 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 7
Equipment and Capacities Strain Process Scale-up Clinical supply manufacturing 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 Pre-filled syringes: up to 20,000 per batch 8
Quality Control Strain Process Scale-up Clinical supply Manufacturing 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 9
Quality Management System Strain Process Scale-up Clinical supply Manufacturing Our Quality management system ensures compliance with cgmp: From early stage to late stage 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 Biotechpharma s electronic quality management system covers: 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 10
Areas of Expertise Bacterial, yeast and mammalian expression systems Cell line and cell banking High productivity biosynthesis process Efficient protein refolding and downstream processes cgmp compliant analytical and stability testing Technological audit and process transfer support Stable protein formulation Drug substance and drug product cgmp manufacturing Project Management 11
Track record selected projects for the last 3 years BigPharma - technology transfer, process validation and GMP manufacturing of commercial API (E.Coli) EU biotech - design and of half-life extension platform for 2 nd generation fusion proteins (E.Coli, K.lactis) BigPharma - Analytical method for biosimilar recombinant monoclonal antibodies comparability studies Drug product formulation for biosimilar monoclonal antibodies. EU biotech - and GMP manufacturing of innovative cytokine for Phase I and II (E.Coli) US biotech - Human cell line for neurotoxin bioassay Asian biotech - of technology to manufacture blood coagulation cascade related protease (CHO) EU biotech - of technology to manufacture biosimilar recombinant blood factor (CHO, BHK) EU biotech - of technology to manufacture biosimilar monoclonal antibodies (CHO) drug substance as well as drug product EU biotech - of cell line for biosimilar MABs (CHO) Multinational Co - testing of operational parameters for chromatographic resins Asian biotech - manufacturing and supply of HCP testing kits based on polyclonal antibodies 12
www.biotechpharma.lt 13