Overcoming process development and biologics manufacturing challenges
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Overcoming process development and biologics manufacturing challenges

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Tom Wellner and David Bell from Therapure Biopharma

Part of the Drug Development Discussion Group Event Series at MaRS. For more information, please visit: http://www.marsdd.com/Events/Event-Calendar/Drug-Development-Discussion-Group/therapure-05152009.html

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Overcoming process development and biologics manufacturing challenges Overcoming process development and biologics manufacturing challenges Presentation Transcript

  • MaRS | May 15, 2009 Thomas G. Wellner – President & CEO Dr. David N. Bell – VP Drug Development & CSO www.therapurebio.com
  • of all new products The future of medicine 1 3 /
  • $51B $87B $25B $89B 2001 Protein therapeutic market 2005 2010 2010 Worldwide mobile technology market
  • 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
  • What about manufacturing ?
  • Discovery Development Marketing Manufacturing
  • Scaling up is not easy
    • Simple
    • Quick
    • Inexpensive
    • Milligrams
    commercial bench
    • Complex
    • Long lead times - 4-5 years
    • Expensive - $150 + million
    • Kilograms
  • 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
  • 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
  • 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
  • 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
  • Our Business Strategy Cornerstone CDMO Business Unique & Flexible Facility Scientific & Biomanufacturing Expertise Creative Financing
    • Develop Products
    • TBI Pipeline
    • Joint Venture
  • 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
  • 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
  • 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
  • Sophisticated Biologic Development & Manufacturing Services
  • 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
  • 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
  • High Quality Manufacturing Facility Chromatography Analytical Laboratory Vial filling line Buffer farm
  • Support Beyond Development & Manufacturing
  • 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