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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:

Published in: Business, Technology

Overcoming process development and biologics manufacturing challenges

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