Biotechpharma company profile. Romanas Ramanauskas Business development manager

Transcription

1 Biotechpharma company profile Romanas Ramanauskas Business manager October,

2 Contents History Company overview Services and capabilities Expression system and process Technology scale-up and GMP manufacturing Quality Assurance Quality Control 2

3 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 areas 2007 Biotechpharma established biopharmaceutical R&D activities and started to develop recombinant protein technologies new biopharmaceutical R&D center was established to provide contract research services 2012 cgmp-compliant biopharmaceutical production facility was constructed

4 Biotechpharma is a contract services company Research and Development Production Quality Business is led by professionals with 20+ years of R&D experience in biochemistry, biology and bioprocess engineering New state-of-the-art GMP facility has experts with 15+ years experience in recombinant protein manufacturing Our quality system ensures process and product compliance at all stages of and commercial manufacturing CMO/CRO business model is executed with support of leading international pharma marketing and sales company 4

5 Facilities R&D centre (1320 sq.m. total area): 800 sq. m. of GLP laboratories for process 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 5

6 Areas of expertise Cell line and cell banking Bacterial, yeast and mammalian expression systems 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 Bulk drug substance and drug product cgmp manufacturing 6

7 Integrated R&D and manufacturing services for all stages of biopharmaceutical Strain Process Scale-up Clinical supply Commercial manufacturing R&D services GMP manufacturing services 1400 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 2000 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 units per batch Lyophilized drug product up to vials per batch Commercial manufacturing drug substance and drug product 7

8 Expression system and process services Strain Process Scale-up Clinical trial supply Production 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 and validation Formulation R&D department 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 8

9 Technology scale-up and GMP manufacturing services Strain Process Scale-up Clinical trial supply Production Technology Transfer Pilot manufacturing and scale-up Manufacturing of microbial and mammalian derived recombinant proteins Drug product F&F 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 9

10 Main process equipment capacities Strain Process Scale-up Clinical trial supply Production Bulk 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 10

11 Quality Control Strain Process Scale-up Clinical trial supply Production QC department performs: Bulk DS/DP release testing Real time, stressed and accelerated stability studies according ICH guidelines Assays / bioassays validation 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 11

12 Quality management system Strain Process Scale-up Clinical trial supply Production Company s Quality management system is implemented following industry guidance: directive 2001/83/EC (code related with medicinal products for human use) directive 2004/27/EC (addition to 2001/83/EC) directive 2003/94/EC (Principals of GMP for medicinal products for human use and investigational medicinal products) EU GMP Guide part I and II ICH Q7 guidance 12

13 Quality management system Strain Process Scale-up Clinical trial supply Production Company s Quality management system ensures compliance with EU and US cgmp Electronic quality management system is in place Quality Assurance covers: Early stage (research) Late stage (production) Quality Control is a part of Quality Unit and covers full range of quality and in-process control activities Biotechpharma s electronic quality management system: 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 13

14 Thank you! 14