PharmaSynth Biopharmaceutical Manufacturing Services - PowerPoint PPT Presentation

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PharmaSynth Biopharmaceutical Manufacturing Services

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Title: PharmaSynth Biopharmaceutical Manufacturing Services


1
Contract Manufacturing Services
2
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.

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
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
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.

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 -80C to controlled
    ambient.

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
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

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

13
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

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
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.

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

17
Thank you
  • Les Tillack - CEO
  • les.tillack_at_pharmasynth.com.au
  • www.pharmasynth.com.au
  • Supporting you
  • From Bench to Clinic to Market
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