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PharmaSynth Biopharmaceutical Manufacturing Services


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PharmaSynth Biopharmaceutical Manufacturing will support you from bench to clinic to market.

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PharmaSynth Biopharmaceutical Manufacturing Services

  1. 1. Contract Manufacturing Services
  2. 2. In a nutshell… PharmaSynth Pty Ltd is one of Australia’s most experienced biopharmaceutical CMOs. • GMP manufacture of: – Recombinant proteins & vaccines – Synthetic molecules – Human & veterinary products – Material for pre-clinical, clinical & market.
  3. 3. History • PharmaSynth is a wholly owned subsidiary of Progen Pharmaceuticals. • Progen started more than 20 years ago as a molecular biology reagents company, moving into drug development about 17 years ago with the development of PI-88. • Progen has offered a contract manufacturing service for most of this time. • 5 years ago, the contract manufacturing division was spun out into PharmaSynth to allow focus on CMO activities without the complexity of being a drug development company.
  4. 4. PharmaSynth Experience More than 15 years of CMO experience across all phases of clinical development • • • • • • Bacterial & Yeast Fermentation; Recombinant proteins; carbohydrates; Synthetic molecules; Vaccines and immunotherapies; and DNA/Gene therapies.
  5. 5. Track Record PharmaSynth has provided services to global, multi-national and local clients. Recent projects include: •Recombinant protein from E.coli for a phase 2 trial in the US under IND; •Recombinant protein from E.coli conjugated to a carbohydrate for a phase 2 in the US under IND and phase 2/3 trial in the EU; •Fermentation sourced Semisynthetic carbohydrate for a phase 3 clinical trial in Asia; •Whole cell killed vaccine for a phase 2 trial in the US and Australia
  6. 6. Facilities • PharmaSynth's 1200m2 facility is located in the suburb of Darra south of the Brisbane CBD. • It comprises of a series of modular clean room laboratories with ISO 8 fermentation suites and support areas. • Purification and final product isolation suites are ISO 7 cleanrooms. • The laboratory area is supported by a range of raw material, in process and finished product storage areas ranging from -80°C to controlled ambient.
  7. 7. Processes & Equipment • • • • • • • • • • • • Fermentation at 5l, 30l and 500l scale Fed batch capabilities Cell recovery by discrete or continuous centrifugation or ultrafiltration Ultrafiltration Microfluidics high pressure homogeniser for cell rupture Chromatography – AKTA 100 system – AKTA Biopilot – AKTA Bioprocess skid Chromatography columns to 200l Final product filtration Lyophilisation bulk and stoppering up to 40l Independent Cell Culture Suites State-of-the-Art Testing Laboratories – with a full array of testing capabilities cGMP Compliant Warehousing – for raw materials and formulated bulk product
  8. 8. Facility Licenses • TGA (Australian FDA equivalent) license for the manufacture of human therapeutic API's from biological and synthetic sources • APVMA (Veterinary equivalent of the TGA) license for manufacture of sterile immunobiological products • OGTR license for products from organisms the production of genetically modified • AQIS facility license for import and use
  9. 9. Microbial Products • Master and working cell bank preparation, validation and storage; • Fermentation and subsequent downstream purification • Up/downscale Fermentation optimisation • Downstream processing optimisation and development
  10. 10. Vaccine Products • Dedicated manufacturing area for production of viral vaccines • Production of live or killed bacterial vaccines • Specialty in formalin killing and removal • Documentation • Support services
  11. 11. Chemical Syntheses • Glass and stainless steel controlled reactors up to 150L; • Multiple fume cabinets and chemical and solvent handling infrastructure; • Wet chemistry; • semi-synthetic expertise.
  12. 12. Product Development Support • Process validation • QC assay performance / development validation • GMP document preparation • Regulatory advice • CMC package development • Product labelling • Product distribution /
  13. 13. Quality Assurance • PharmaSynth operates and is compliant with the PIC/S GMP code • Audited and certified by the TGA • Audited by clients including the Pfizer global Audit Team
  14. 14. Global Client Base PharmaSynth has worked with clients from Australia, Europe, America & Asia, including China and Taiwan. • Our clients include biopharmaceutical development companies, research institutes, veterinary drug companies and Universities. • We routinely repeat manufacture for ongoing trial requirement • PharmaSynth has developed effective global freight processes for moving clinical trial material and other perishable products quickly and securely on behalf of clients.
  15. 15. Wide Range of Service • Can manufacture most types of API’s • Expertise in biopharmaceutical production from bacterial / yeast cell lines. • GMP material for: – – – – pre-clinical; Clinical; Phase 1, 2 & 3; Market. • Highly cost competitive.
  16. 16. Flexibility • We have a flexible approach to scheduling and can often accommodate short notice requirements. • Your proposed manufacturing activities may be eligible for the Australian R&D Tax Incentive. – Up to 45% cash refund for eligible R&D expense • PharmaSynth is a Commonwealth Registered Research Provider (RSP89446)
  17. 17. Thank you Les Tillack - CEO Supporting you From Bench to Clinic to Market