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Advanced Aseptic Manufacturing Solutions for Clinical Trial Material

Advanced Aseptic Manufacturing Solutions for Clinical Trial Material. Paris, 26 – 27 January 2010. NextPharma Technologies. Introduction. Market and Clinical Pipeline Challenges of NCEs Manufacturing Solutions. Market outlook. World pharmaceutical market forecast is $750bn in 2009

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Advanced Aseptic Manufacturing Solutions for Clinical Trial Material

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  1. Advanced Aseptic Manufacturing Solutions for Clinical Trial Material Paris, 26 – 27 January 2010

  2. NextPharma Technologies Introduction • Market and Clinical Pipeline • Challenges of NCEs • Manufacturing Solutions

  3. Market outlook World pharmaceutical market forecast is $750bn in 2009 Expected growth rate: 3 – 6% per year through 2013 Weight of biomedicines: $127bn by 2012 (more than 15%) Expected growth rate: 12% per year Anticancer drugs: $80bn by 2012 Expected growth rate: 12% per year Injectables: $147bn (20% of the entire market) Expected to grow at 11% per year through 2012 (26% of market) NextPharma Technologies

  4. NextPharma Technologies Clinical pipeline • Over the last 4 years, 30% of NCE were biomedicines The number of biologics in Phase I has been multiplied by 6, in contrast to only 2 for small molecules • Top targeted disease area is cancer which represents 30% of the global pipeline and 35% of biologics • More than half of the drugs in development are for parenteral administration of which 75% of all biologics

  5. NextPharma Technologies Source : Leem Biotech Bioproduction 2008

  6. NextPharma Technologies Source: Leem Biotech Bioproduction 2008

  7. NextPharma Technologies Source: Availability of medicines and supporting therapies in pediatric oncology -- Warsaw – Oct. 14, 2009

  8. NextPharma Technologies Challenges - Biologics • Minimal quantities of API available (g vs kg) • Unknown toxicity • Stability issue • Solubility issue • Controlled-release formulations to extend half-life and to reduce dose-related side-effects

  9. NextPharma Technologies Challenges - Anticancer drugs • Extremely high potency levels and/or toxicity • Tumor-targeting formulations • Fast-track development programs and high failure rates • Small batch size

  10. NextPharma Technologies How to address these challenges? • Facility Design • Highly flexible manufacturing from Formulation Development to Clinical Trial Material and Commercial Supply • Innovative drug delivery systems

  11. NextPharma Technologies Formulation labs at NextPharma Solubilization and stabilization Targeted and sustained drug delivery systems Lyo cycle development Process parameters

  12. NextPharma Technologies Development Center and Commercial Manufacturing Manufacturing and supply of Phase I to Phase III Clinical Trial Material Cytotoxic and biologics/conventional drugs in segregated units (Toxicity 4) Clinical Trial Packaging, labeling and storage Scaling-up, validation, registration and commercialization

  13. NextPharma Technologies Flexibility • 2-100ml glass and plastic vials handled on standard trays • Washing machine • Oven • Filling line • Freeze-dryer • Capping • Automatic tool-free filling and stoppering machine ( 14.25 – 52 mm)

  14. NextPharma Technologies Flexibility • Temperature control through the manufacturing process • Oxygen control in solution + head space • Light control in RABS • Compatibility with material • stainless steel or glass vessels, flex bags EVA et PE • PES, PVDF, Nylon® filters • Pt silicone, Teflon® tubings

  15. NextPharma Technologies Innovative Drug Delivery Systems • Solvent-based formulations • Controlled release matrix • Nanoscale drug carriers • Conjugated APIs

  16. NextPharma Technologies Case study 1 - Oxygen control • Filling machine: Head space in the vials: • Current process Filling N2 N2 Stoppering

  17. NextPharma Technologies Case study 1 - Oxygen control • Filling machine: Head space in the vials • Improvement N2 Filling N2 Stoppering

  18. NextPharma Technologies Case study 2 - Quantity of API • Lyo cycle development and Phase I clinical trial material • 800mg API available for lyo cycle development • Determination of freeze-drying parameters on small vials (2R) • Freezing • Sublimation • Secondary drying • Transposition to the final dosage form (10R vials) - adjustment of phases length only, with same pressure and t° parameters

  19. NextPharma Technologies Case study 3 – Fast to Clinic • Freeze-dried drug product for First In Humans • Fast to clinic • Aseptic manufacturing and IPC • Clinical trial packaging and labeling • Final release testing • QP release 3 weeks after manufacturing date

  20. NextPharma Technologies Case study 4 - Prefilled syringes • Sterile depot formulation in PFS for intra-articular administration • Rheumatoid arthritis • Semi-automatic filling of syringes with peristaltic pump • Stopper placement unit under vacuum • 0.5-20ml PFS

  21. NextPharma Technologies Case study 5 – Closed Vial Technology • Allow clients to use a new technology • Minimize investment costs • Offer key advantages for patient quality and ease of use to pharmaceutical companies • Create partnership with Aseptic Technologies • Leverage both EMEA approved / FDA registered facility and preliminary R&D setting

  22. MOLDING SITE IRRADIATION UNIT New concept of Crystal® Sterilization (Gamma irradiation) Molding & Closing (Class ISO 5) Assembly (Class ISO 8) PHARMACEUTICAL SITE Filling line under barrier (Class ISO 5) Clean & Sterile ready-to-fill vial Capping Laser re-sealing Filling

  23. Authority approved filling facility • Offer in-house ad-hoc contract manufacturing for small quantities of GMP material (e.g., stability batches), especially to client interested to test the concept EMEA approved 2 DMF filed at FDA Approved for recombinant viruses Clinical line in Class ISO8 at Aseptic Technologies

  24. Preliminary R&D filling facility • Offer in-house ad-hoc contract manufacturing for small non-GMP quantities to perform R&D investigation Clinical line and lyo unit in Class ISO8 at Aseptic Technologies

  25. Examples of filling performed • Filling of GMP batches: • Filling of 3000 vials for stability tests with two vaccines • Filling of 3 recombinant viruses for stability tests • Ad-hoc R&D projects: • Filling of 4 x 10 vials (2ml) with a protein to investigate reasons for lack of stability in glass vials • Filling of 2 x 400 vials (1ml) of an antibody to investigate stability in oxygen free condition and in presence of oxygen • Filling of 300 vials (1ml) to investigate stability of a recombinant virus in accelerated conditions • Filling of 500 vials to investigate stability on 2 year basis with a recombinant protein

  26. NextPharma Technologies Case study 6 - Controlled release matrix • Injectable depot formulation for Phase I clinical trial • Lipid-based sterile solution • Cyclic peptide • 800 vials – 1,4ml fill volume • High sensitivity to water => • Anhydrous formulation • Ethanol rinse of equipments and pipes • Nitrogen flush • High viscosity of excipients => • Compounding with viscosity-controlled stirring • Larger tubing for dispensing

  27. NextPharma Technologies Case study 7 - Nanoparticles • Injectable nanoscale drug carrier of a cytotoxic drug for Phase II clinical trial • API entrapped in nanoparticles • Freeze-dried sterile formulation • Dissolution of API and sterile filtration of the solution • Aseptic addition of monomer => emulsion (isolator) • In situ polymerization – control of particle size! • Aseptic filling and freeze-drying

  28. NextPharma Technologies Conclusions • Facility Design and equipments adapted to highly sensitive and highly potent drugs • Cost and Time efficiency • Advanced manufacturing solutions

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