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Medipolis GMP Oy Presentation -Dr. Ashesh Kumar Director-Biopharmaceuticals

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  • 1. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT Biopharmaceutical Development Capabilities and EMEA Approved cGMP Manufacturing at Medipolis GMP, Oulu, Finland By MEDIPOLIS GMP Ltd Kiviharjunlenkki 2, 90220 Oulu, Finland 1 SERVICES FOR PILOT PRODUCTION
  • 2. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT Medipolis GMP Medipolis GMP is a Finnish CMO and a Process Development and Optimization group specialized in.. -cGMP production with microbial fermentation, -Cell culture based process development, -CHO expression systems for Full length Monoclonal Antibody and -Process development services for biopharmaceutical companies. Our mission is to add value for our customers to bring their products to the market fast and cost efficiently by offering reliable partnership in manufacturing. We see ourselves as an converter between the lab bench scale and commercial production ie. To change the process from lab scale to industrial form. 2 SERVICES FOR PILOT PRODUCTION
  • 3. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT Medipolis GMP Finland • Specialized in microbial fermentation • Focused in small scale production of bulk material (API) for toxicological and clinical production; therapeutic proteins,enzymes, therapeutic vaccines,plasmid DNA, etc. •Process Development and optimization Capabilities in cell culture expressions of Full length Monoclonal Antibody (Mabs)and their Fragments • Process development and scale up services • Excellent network for fill and finnish and large scale production 3 SERVICES FOR PILOT PRODUCTION
  • 4. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT FACILITY • Built for biopharmaceutical production in 2000- 2001 •23000 Square Feet/ 4000 Square Feet clean room • Meets FDA and EMEA requirements for biopharmaceutical manufacturing • Inspected by and license from NAM ( Finnish EMEA Authority) Production area in A/B, C and D classes * • Bio safety level BL 3 * Clean Room Classification: A= 100 particles per sq ft , B = 1000 particles per sq ft , C = 10 000 particles per sq ft and D = 100000 particles in q ft. s 4 SERVICES FOR PILOT PRODUCTION
  • 5. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT GMP FACILITY • 3 floor building: base floor for clean utilities, maintenance, warehousing, liquid waste treatment, mid floor for clean room, in process and analytical laboratory, washing rooms ( in Class D) and top floor for HVAC • One fermentation suite in class C • Harvesting suite in Class C • Purification suite in Class C, temperature of one of the rooms can be lowered to +4 C • Dedicated buffer and media preparation area, Class C, • Lyopholization and final filtration in A / B area • 5 HVAC units for the clean room • Continuous waste contamination for liquid waste and decontamination autoclave for solid waste • BL 3 capability and technical readiness 5 SERVICES FOR PILOT PRODUCTION
  • 6. Clean Room Facilities COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT •Dedicated facility designed and built for Biopharmaceutical Production •23000 Square feet total area / 4000 square feet clean room area •Class A/B, C and D •BL 3 •FDA and EU compliant •Production License granted by Finnish National Agency of Medicine •Regularly inspected by NAM •Trained and Experienced Personnel 6 SERVICES FOR PILOT PRODUCTION
  • 7. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT Microbial expression systems • E.coli, cGMP manufacturing and process development experience • Pichia, very strong process development and production experience • Bacillus subtilis, strong cGMP manufacturing experience • CHO Expression system for Full Length Anticancer Monoclonal Antibody Expressions • SCFv Development as a part of EU project to use as Biomarkers Etc. 7 SERVICES FOR PILOT PRODUCTION
  • 8. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT MAIN USP AND DSP EQUIPMENT IN GMP • 2 X 15 liter , 1 x 150 liter and 1 x 750 liter fermentors ( B.Brown) • Homogenizers ( APV) • Centrifuges, both continuous and batch ( Westfalia, Beckham) • 2 Tangential Flow Filtration Units ( Sartoflow) • 3 Chromatographic units ( GE-Healthcare) • Protein crystallizer ( Custom made) • Lyophilization unit ( Tellstar) We also very commonly use disposables that gives us flexibility Process Development Laboratory • 2 X 10 liter fermentors • 2 x 15 liter fermentors • Downstream equipment • Basic analytical equipment 8 SERVICES FOR PILOT PRODUCTION
  • 9. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT 9 SERVICES FOR PILOT PRODUCTION
  • 10. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT 10 SERVICES FOR PILOT PRODUCTION
  • 11. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT 11 SERVICES FOR PILOT PRODUCTION
  • 12. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT 12 SERVICES FOR PILOT PRODUCTION
  • 13. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT 13 SERVICES FOR PILOT PRODUCTION
  • 14. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT Main analytical equipment in GMP: •HPLC (Agilent 1100) •GC (Agilent 6890) •CE (Hewlett Packard 3D CE) •Polarimeter (Jasco P-1020) •UV/ Vis Spectrophotometer (Shimadzu UV-2401 PC, temperature controlled) •TOC Analyzer (Shimadzu TOC-5000A) •Microplate/ELISA Reader (Labsystems iEMS Reader MF) •Melting point apparatus (Buchi B-545) •Mettler Toledo titrators DL53 and DL38 (KF) •Mettler Toledo refractometer RE40D •FT-IR Spectrometer (Perkin Elmer Spectrum One) •pH-meters, • SDS-PAGE, •TLC, 14 SERVICES FOR PILOT PRODUCTION
  • 15. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT SERVICES FROM GENE TO CLINICAL Medipolis GMP offers both process development services and produces GLP material for preclinical studies and GMP material for clinical phase I to II trials • Development of expression systems starting from gene • Process development • Production of preclinical material • Technology transfer • cGMP production – Fermentation – Downstream • Analytical services • Freeze drying • GMP documentation • QA / QC Support • GMP consulting 15 SERVICES FOR PILOT PRODUCTION
  • 16. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT TRACK RECORD • Produced the largest amount of recombinant therapeutic protein in Finland • Produced successfully material for clinical phase II trials for biopharmaceutical companies for Finnish and international clients • Manufacturing license upgraded for commercial production 16 SERVICES FOR PILOT PRODUCTION
  • 17. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT PERSONNELL • 19 Employees – 6 in Process Development and Optimzation – 5 in QA / QC – 8 in production and process development • 1 PhD in Biosciences and Biotechnology, 2 Tech. Lic. in bio processing, 4 M.Sc. in organic chemistry, bioprocess engineering etc, B.Sc in pharmacy, bioprocess engineering, Lab technicians etc. • More than 100 years experience in pharmaceutical industry ( commercial production ) and over 50 years in modern biotech • Personnel has strong industrial experience in cGMP manufacturing, QA/QC and regulatory affairs 17 SERVICES FOR PILOT PRODUCTION
  • 18. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT CUSTOMER BENEFITS 18 SERVICES FOR PILOT PRODUCTION
  • 19. COMPANY TEAM+REFERENCES SERVICES FACILITY+EQUIPMENT THANK YOU for your Attention. For Further Details Please contact- Dr. Ashesh Kumar Director- Biopharmaceuticals Medipolis GMP Oy Kiviharjunlenkki 2, Oulu Finland Kumar.ashesh@medipolisgmp.com Phone- 358-400207380. 19 SERVICES FOR PILOT PRODUCTION