THOMAS C. RANSOHOFF Vice President and Principal Consultant

Transcription

1 THOMAS C. RANSOHOFF Vice President and Principal Consultant (o) (m) Profile An expert in the development and scale-up of biopharmaceutical processes; separations and purification technologies; CMC program management; cgmp manufacturing; and management of technology-based start-up businesses. Extensive experience helping companies of all sizes advance a wide range of biologic products into the clinic and onto the market. Experience BioProcess Technology Consultants, Inc., Woburn, MA Vice President and Principal Consultant (2014-present) Vice President and Senior Consultant (2007-Present) Senior Consultant ( ) CMC consultant to the biopharmaceutical industry providing strategic and technical services related to development, scale-up, manufacturing, and outsourcing for biopharmaceutical products. Additional responsibilities include internal management and strategic planning Present BioFlash Partners, LLC, Marlboro, MA President and CEO Co-founded and managed a virtual bioseparations company from founding and seed financing through successful sale of the company s assets in March Built an organization to demonstrate feasibility of the pre-packed chromatography column technology, established capability to supply product, and negotiated several technology licensing deals and final asset sale TranXenoGen, Inc., Shrewsbury, MA Vice President, Operations Responsible for process and analytical development and facility renovation for a start-up avian transgenic company. Supported CEO in establishing collaborations with large biopharmaceutical firms Dyax Corp, Cambridge, MA Vice President, Program Management and Product Development ( ) Vice President, Bioseparations ( ) Directed technical and commercial development for a business unit formed to commercialize phage display technology in the bioseparations market. Built the business from concept stage to established leadership position in affinity separations field BioProcess Technology Consultants, Inc. 12 Gill Street Suite 5450 Woburn, MA 01801

2 Repligen Corp., Cambridge, MA Senior Director, Manufacturing ( ) Director, Cambridge Manufacturing ( ) Manager, Cambridge Manufacturing ( ) Directed manufacturing operations at two GMP manufacturing facilities to support clinical trials of novel therapeutic proteins and monoclonal antibodies, contract manufacturing obligations, and recombinant Protein A product sales. Led the procurement and successful execution of contract manufacturing business Dorr-Oliver, Inc., Milford, CT (formerly Biotage, Charlottesville, VA) Development Manager and Senior Process Engineer Responsible for the development, design, and project management of preparative HPLC and sanitary production LC systems for use in cgmp production facilities Xoma Corporation, Berkeley, CA Process Engineer Developed new formulations for monoclonal antibody and antibody-toxin conjugate products, solving critical stability problems. Scaled up purification processes for antibody-based therapeutics Education University of California, Berkeley, CA M.S. Chemical Engineering Massachusetts Institute of Technology, Cambridge, MA S.B. Chemical Engineering Board Memberships Tarpon Biosystems, Inc., Worcester, MA Co-founder and Advisor Barofold, Inc., Boulder, CO Scientific Advisor Natrix Separations, Inc., Burlington, Ontario, Canada Scientific Advisor Zepteon Inc., Enfield, NH Scientific Advisor BioPharm Magazine Editorial Advisory Board Present 1998-Present Thomas C. Ransohoff Page 2

3 BioProcess International Conference & Exhibition Scientific Board of Advisors 2004-Present Professional Associations International Society of Pharmaceutical Engineering Boston Area Chapter Advisory Board, present Recent Presentations Ransohoff T. Challenges in forecasting demand and the value of flexibility in manufacturing. Presented at BPI West; 2017 Feb 27-Mar 2; San Francisco, CA. Ransohoff T. Informing the business decision for continuous bioprocessing. Presented at BPI; 2016 Oct 4-7; Boston, MA. Ransohoff T. The potential impact of biosimilars on the biopharmaceutical capacity landscape. Presented at BioProcessing Asia; 2014 Nov 3-6; Langkawi, Malaysia. Ransohoff T. BioFlash Partners - A brief history of an angel-funded business. Presented at McLane Law Firm's Business Workshop: Working with Angel Investors; 2013 Mar 20; Woburn, MA. Ransohoff T. The potential for continuous chromatography in clinical manufacturing of biopharmaceuticals. Presented at IBC Life Science s Biopharmaceutical Development and Production Week: Methods and Molecules; 2013 Feb 26-Mar 1; Huntington Beach, CA. Ransohoff TC. The use of disposable technologies in biopharmaceutical purification processes. Presented at the American Association of Pharmaceutical Scientists Annual Meeting; 2012 Oct 14-18; Chicago, IL. Ransohoff TC. Can continuous purification of biopharmaceuticals become a reality? Presented at International Business Communication s Seventh Annual Biopharmaceutical Manufacturing and Development Summit; 2011 Sep 12-14; San Diego, CA. Ransohoff T. Manufacturing capacity trends and disposable technology. Presented at Hanson Wade's World Antibody Manufacturing and Development Pre-conference Workshop; 2011 May 24; Boston, MA. Ransohoff T. Global trends in mammalian cell culture capacity and biomanufacturing. Presented at the Swiss Biotech Program at BioPharm America 2011; 2011 Sep 6; Boston, MA. Ransohoff TC. Biomanufacturing capacity: The bottleneck moves downstream. Presented at the International Society for Pharmaceutical Engineering s Annual Meeting; 2010 Nov 7-10; Orlando, FL. Ransohoff TC. Disposable technologies for purification of biopharmaceuticals. Presented at the Society for Industrial Microbiology New England Section s Winter Meeting; 2009 Dec 14; Boston, MA. Ransohoff TC. If you build it, will they come? The promise and perils of investing in biomanufacturing capacity. Presented at Sanford C. Bernstein s Second Annual Biosimilars Conference; 2009 Nov 19; New York, NY. Thomas C. Ransohoff Page 3

4 Ransohoff TC, et al. BioSMB Continuous disposable multicolumn chromatography process. Presented at Cambridge Healthtech Institute s PEGS Protein Engineering Summit, Second Annual Protein Scale-up and Manufacturing Conference; 2009 Apr 9-10; Boston, MA. Ransohoff TC. The ever-changing landscape of biopharmaceutical API outsourcing. Presented at the Drug Chemical and Associated Technologies, the Institute for Supply Management and ICIS Chemical Business America s Strategic Sourcing Summit & Showcase; 2007 Oct 24-25; New Brunswick, NJ. Ransohoff TC. Evaluating strategic options for biomanufacturing. Presented at International Business Communication Life Sciences Second International Biomanufacturing and Development Summit; 2006 Dec 6-7; Orlando, FL. Ransohoff TC. The use of disposable and alternative purification technologies for biopharmaceuticals. Presented at the Institute for International Research s Biopharmaceutical Production Conference; 2005 Jul 20-22; San Francisco, CA. Ransohoff TC, Levine HL. Assessing strategic options for biologics manufacturing. Presented at Strategic Research Institute s Third Annual World Antibody Summit; 2004 July 19-21; Philadelphia, PA and at International Business Communications Life Sciences Bioprocess International Conference; 2004 Oct 4-7; Boston, MA. Ransohoff TC. Capacity analysis for biomanufacturing. Presented at Cambridge Healthech Institute s PepTalk Conference; 2004 Jan 12-15; San Diego, CA. Mika AM, et al. A new type of membrane for chromatography applications. Poster presented at Recovery for Biologics, XI Conference; 2003 Sep 14-19; Banff, Canada. Ransohoff TC, et al. The use of economic models to support biopharmaceutical capital decisions. Presented at the Recovery of Biologics XI Conference; 2003 Sep 14-19; Banff, Canada. Ransohoff TC. Implementation of new technologies in biopharmaceutical manufacturing. Presented at Barnett International s Biomanufacturing Conference; 2002 Sep 30-Oct 1; Boston, MA. Full presentation list is available upon request Recent Publications Hummel, J et al. Modeling the downstream processing of monoclonal antibodies reveals cost advantages for continuous methods for a broad range of manufacturing scales. Biotech. J doi: /biot Hejnaes, K, Ransohoff TC. Chemistry, manufacture and control. In: Jagschies G. et al, editors. Amsterdam (NL): Biopharmaceutical processing: Development, design, and implementation of manufacturing processes. Elsevier Ltd; Riske F, Ransohoff T. Development of continuous capture steps in bioprocess applications. In: Staby A. et al, editors. Hoboken (NJ): Preparative chromatography for separation of proteins. John Wiley & Sons, Inc; 2017 Feb Doig A, Ecker D, et al. Monoclonal antibody targets and indications. Am Pharma Rev 2015 Jul-Aug; 18(5): Thomas C. Ransohoff Page 4

5 Stock L, et al. The potential impact of continuous processing on the practice and economics of biopharmaceutical manufacturing. In: Subramanian G, editor. Hoboken (NJ): Continuous Processing in Pharmaceutical Manufacturing. John Wiley & Sons, Inc; 2015 Feb Jones S, Ransohoff T, et al. High-throughput process development approaches for biopharmaceuticals. Am Pharm Rev 2015 Jan-Feb;18(1): Ecker DM, Ransohoff TC. Mammalian cell culture capacity for biopharmaceutical manufacturing. In: Zhou W, Kantardjieff A, editors. Mammalian Cell Cultures for Biologics Manufacturing. Dordrecht (NL): Springer Science+Business Media B.V.; 2014 Jan. p (Advances in Biochemical Engineering/Biotechnology; Vol. 139). Ransohoff T, Seymour P. No capacity crunch in sight. Pharm Technol May;36(5):38. Ecker DM, Ransohoff TC, et al. The state of mammalian cell culture biomanufacturing. Woburn (MA): BioProcess Technology Consultants, Inc.; 2011 Dec p. Available from: Jones SD, Ransohoff TC. Use products for bioproduction-available options for cell culture and downstream processing. Amer Pharm Rev May-Jun;14(4): Blackwell J, Ransohoff TC, et al. Monoclonal antibody manufacturing strategies for the 21st century. Pharm Outsourcing Jul-Aug;11(4): Ransohoff TC, et al (BioProcess Technology Consultants, Inc., Woburn, MA). Cell culture manufacturing capacity: trends and outlook through Springfield (VA): Pharmsource Information Services; 2008 Dec. 126 p. Ransohoff TC. The rise of biopharmaceutical contract manufacturing. Biopharm Int.2007 Oct;20(10): Ransohoff TC, Levine HL. A method for forecasting industry-wide biopharmaceutical manufacturing capacity requirements. In: Langer E, editor. Advances in large scale biopharmaceutical manufacturing and scale-up production. 2nd ed. Rockville (MD) and Washington, DC: BioPlan Associates, Inc. and American Society for Microbiology Press; p Blackwell JV, Ransohoff, TC, et al. 4th annual report and survey: biopharmaceutical manufacturing capacity and production, In: Langer ES, editor. Rockville (MD): BioPlan Associates Inc.; 2006 Jun. 152 p. Ransohoff TC, et al. Forecasting industry-wide biopharmaceutical manufacturing capacity requirements. In: Langer E, editor. Advances in large-scale biopharmaceutical manufacturing and scale-up production. Vol 2. Washington, DC and Rockville (MD): American Society for Microbiology Press and Institute for Science and Technology Management; p Ransohoff TC. Considerations impacting the make v. buy decision. Amer Pharm Outsourcing Mar-Apr;4(2):[7 p.]. Full publication list is available upon request Thomas C. Ransohoff Page 5

6 Patents (Application) Ransohoff T, Bisschops M, inventors; Tarpon Biosystems, Inc., assignee. Continuous processing methods for biological products. WO A3. Publication date 2012 Aug 02. Maclennan JM, Ransohoff TC, et al, inventors; Dyax Corp., assignee. Purification of tissue plasminogen activator (tpa). United States patent US 7,074, Jul 11. Green JR, Ransohoff TC, et al, inventors; Dyax Corporation, assignee. Liquid chromatography column. United States patent US 6,171, Jan 9. Maclennan JM, Ransohoff TC, et al, inventors; Dyax Corp., assignee. Polypeptides that bind to tissue plasminogen activator (tpa). United States patent US 6,084, Jul 4. Conroy CM, Ransohoff TC, et al, inventors; Dyax Corporation, assignee. Liquid chromatography column. United States patent US 6,001, Dec 14. Ransohoff TC, inventor; Biotage, Inc., assignee. Column protection system for liquid chromatography system. United States patent US 5,242, Sep 7. Ransohoff TC, inventor; Biotage, Inc., assignee. Automated bubble trap. United States patent US 5,112, May 12. Mahar JT, Ransohoff TC, et al, inventors; Biotage, Inc., assignee. Gradient generation control for large scale liquid chromatography. United States patent US 5,089, Feb 18. Thomas C. Ransohoff Page 6