Overcoming process development and biologics manufacturing challenges

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    Overcoming process development and biologics manufacturing challenges - Presentation Transcript

    1. MaRS | May 15, 2009 Thomas G. Wellner – President & CEO Dr. David N. Bell – VP Drug Development & CSO www.therapurebio.com
    2. of all new products The future of medicine 1 3 /
    3. $51B $87B $25B $89B 2001 Protein therapeutic market 2005 2010 2010 Worldwide mobile technology market
    4. You discovered a protein with blockbuster potential
      • Specific
      • Safe
      • Targeted
      • Efficacious
      • Novel
      • Ultimately, to get your product approved you will invest…
      You are working hard to develop it
      • 11 years
      • 5 clinical trials
      • 2,000 patients
      • 39 patents
      • ~$1 billion
    5. What about manufacturing ?
    6. Discovery Development Marketing Manufacturing
    7. Scaling up is not easy
      • Simple
      • Quick
      • Inexpensive
      • Milligrams
      commercial bench
      • Complex
      • Long lead times - 4-5 years
      • Expensive - $150 + million
      • Kilograms
    8. Therapure Biopharma: Overcoming the manufacturing barrier Complex We know protein purification Long lead times Ready to go now Quality cGMP compliant Expensive Established Meadowpine Facility Regulated We have 8 INDs under our belts
    9. Therapure Biopharma Inc.
      • Flexible, modern cGMP manufacturing facility
      • Expertise in manufacturing & downstream purification
      • Extensive quality systems
      • Deep understanding of advanced biology & complex proteins
      • Creative partnering options
      Committed to the development, manufacture, purification, and packaging of high-quality biological therapeutics
    10. Therapure Biopharma – Key Facts
      • Company Established
      • Assets of former Hemosol business acquired Q3/2007 including modern and flexible Health Canada approved facility
      • Therapure Biopharma Inc. launched Q3/2008
      • Ownership Financing
      • Privately held by Catalyst Fund Limited Partnership II, a Canadian based private equity fund, and management
    11. Modern and Flexible Facility
      • Facility Built: 2003
      • Size: 130,000 ft 2 (12,000 m 2 )
      • Location: Toronto, Canada (Mississauga)
      • Minutes from Toronto’s Lester B. Pearson International Airport
      • Employees: 65
      • Capabilities
      • Development, manufacture and fill/finish of therapeutic proteins
      • Product development
      • Process development
      • Manufacturing
      • Fill/finish
      • Lyophilization
      • Designed to meet U.S. FDA, Health Canada and EMEA requirements
    12. Our Business Strategy Cornerstone CDMO Business Unique & Flexible Facility Scientific & Biomanufacturing Expertise Creative Financing
      • Develop Products
      • TBI Pipeline
      • Joint Venture
    13. Key Milestones
      • Therapure Biopharma Inc. established July/08
      • Manufacturing plant re-validated Sept/08
      • Key talent retained and hired
      • Plant upgraded to create flexible multi-use facility Dec/08
      • Several key partner/client agreements executed
        • Revenue generation in 2008
        • Break even goal in 2009
      • Business development activities increasing
      • Pipeline milestones achieved for core assets
      • Health Canada re-certification of plant – May/09
    14. Key Clients / Global Collaborations
      • Client project opportunities continue to grow
      • Rare protein development project
      • Growth factors for stimulating bone regeneration
      • Iron Chelating Agent for thalassemia
      • PEGylated biologic oncology product
    15. Experienced Sr. Management Team
      • Thomas Wellner President and CEO Eli Lilly & Co.
      • Dirk Alkema, Ph.D. Vice President, Operations Connaught Labs and Hemosol
      • Peter Winkley, CA Vice President Finance and CFO MDS and Ernst & Young
      • David Bell, Ph.D. Vice President, Drug Development and CSO BioChem Therapeutic Inc and FAA
    16. Sophisticated Biologic Development & Manufacturing Services
    17. Integrated Full Service Provider
      • “ One stop-shop ” for development and manufacture of therapeutic proteins
      • Cost-effectively manage all aspects of development and manufacturing at both small (mg) and large (kg) scale:
        • Upstream processing
        • Downstream processing
        • Clinical supplies including distribution
        • Commercial manufacturing
        • Fill and finish
        • Lyophilization
        • Full analytical support
    18. Fully Integrated Services
      • Upstream Processing
      • Molecular biology
      • Cell line creation &banking
      • Mammalian cell cultures
      • Downstream Processing
      • Protein modification
      • Purification
      • Stabilization
      • mg to kg scale batches
      • Preclinical scale
      • Clinical scale
      • Commercial scale
      • Aseptic filling of glass vials & preformed bags
      • Lyophilization
      • Clinical supplies including distribution
      Commercial Product
    19. High Quality Manufacturing Facility Chromatography Analytical Laboratory Vial filling line Buffer farm
    20. Support Beyond Development & Manufacturing
    21. Creative Financing Opportunities
      • Therapure can potentially offer creative financing to partners who require development and biomanufacturing services:
        • Secured Debt
        • Equity partnership
        • Joint Venture
      • Your trusted partner for protein development & manufacturing
      www.therapurebio.com

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