PharmaSynth Biopharmaceutical Manufacturing Services

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Contract Manufacturing Services
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In a nutshell
PharmaSynth Pty Ltd is one of Australias most
experienced biopharmaceutical CMOs.

• GMP manufacture of
• Recombinant proteins vaccines
• Synthetic molecules
• Human veterinary products
• Material for pre-clinical, clinical market.

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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.

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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.

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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 Australiaunder IND.

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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 -80C to controlled
  ambient.

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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

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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 the production of products from
  genetically modified organisms
• AQIS facility license for import and use of
  biologic materials

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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

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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

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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.

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Product Development Support

• Process validation
• QC assay performance / development / validation
• GMP document preparation
• Regulatory advice
• CMC package development
• Product labelling
• Product distribution

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Quality Assurance

• PharmaSynth operates and is compliant with the
  PIC/S GMP code
• Audited and certified by the TGA
• Audited by clients including thePfizer global
  Audit Team

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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.

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Wide Range of Service

• Can manufacture most types of APIs
• Expertise in biopharmaceutical production
  frombacterial / yeast cell lines.
• GMP material for
• pre-clinical
• Clinical
• Phase 1, 2 3
• Market.
• Highly cost competitive.

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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 RD Tax Incentive.
• Up to 45 cash refund for eligible RD expense
• PharmaSynth is a Commonwealth Registered Research
  Provider (RSP89446)

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Thank you

• Les Tillack - CEO
• les.tillack_at_pharmasynth.com.au
• www.pharmasynth.com.au
• Supporting you
• From Bench to Clinic to Market