Contract Manufacturing Services

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.

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.

PharmaSynth ExperienceMore 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.

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.

Track Record

• 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.

Facilities

• 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

Processes & Equipment

• 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

Facility Licenses

• Master and working cell bank preparation, validation and storage;

• Fermentation and subsequent downstream purification

• Up/downscale Fermentation optimisation

• Downstream processing optimisation and development

Microbial 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

Vaccine Products

• Glass and stainless steel controlled reactors up to 150L;

• Multiple fume cabinets and chemical and solvent handling infrastructure;

• Wet chemistry;• semi-synthetic expertise.

Chemical Syntheses

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

Product Development Support

• 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

Quality Assurance

• 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.

PharmaSynth has worked with clients from Australia, Europe, America & Asia, including China and Taiwan.

Global Client Base

• 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.

Wide Range of Service

• 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)

Flexibility

Thank you

Les Tillack - CEOles.tillack@pharmasynth.com.au

www.pharmasynth.com.au

Supporting you

From Bench to Clinic to Market