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SPEED TO IND: RISKS TO ACHIEVING AGGRESSIVE BREAKTHROUGH/FAST-TRACK PRODUCT TIMELINES

By: Susan Dana Jones Presented at: KNect365 BioProcess International West Conference, February 27-March 2, 2017. The pharmaceutical industry is highly motivated by financial incentives to advance product candidates into first-in-human trials quickly. The drive to get biopharmaceuticals into the clinic quickly often leads companies to use platform manufacturing processes that are sufficient...

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BPTC Article is Finalist for ISPE’s Pharmaceutical Engineering – Roger F. Sherwood Article of the Year Award

Our article entitled: “Biopharmaceutical Manufacturing Process Validation and Quality Risk Management”, authored by Francisco C. Castello, Ph.D., Brendan Cooney and Howard L. Levine, Ph.D. of BioProcess Technology Consultants, has been chosen as a top five contribution by ISBE for 2016. The article appeared in the May/June 2016 edition of Pharmaceutical Engineering® Magazine. The...

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BPTC’s Tom Ransohoff to present on biopharmaceutical demand forecasting at BPI-West

At the upcoming BioProcess International West Conference (Feb 27-Mar 2, 2017, San Francisco), Tom Ransohoff, Vice President and Principal Consultant at BioProcess Technology Consultants, will present a paper entitled “Challenges in Forecasting Biopharmaceutical Demand and the Value of Flexibility.” In this talk, Mr. Ransohoff will review the sources of uncertainty...

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BPTC’s Frank Riske to give Keynote at PEGS Europe

Frank Riske, Ph.D., Senior Consultant at BioProcess Technology Consultants will be delivering the Keynote Address entitled: Biopharmaceuticals: Past, Present & Future at the 8th Annual PEGS Europe Conference in Lisbon, Portugal. His presentation will cover the evolution of bioprocessing starting with the production of molecules such as insulin, HGH and...

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Opportunities for Continuous Manufacturing in Biopharmaceutical Production

Thomas C. Ransohoff, M.S., Vice President and Principal Consultant at BPTC, gave a presentation entitled "Opportunities for Continuous Manufacturing in Biopharmaceutical Production" at the World BioPharm Forum 2016: Progress in Continuous Biomanufacturing, on June 28, 2016 held at Robinson College, Cambridge, UK. Tom's presentation focused the potential benefits of continuous manufacturing in the production of...

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Opportunities for Continuous Manufacturing in Biopharmaceutical Production

By: T. Ransohoff Presented at: World BioPharm Forum 2016: Progress in Continuous Biomanufacturing; 2016 Jun 27-28; Robinson College, Cambridge, UK The potential benefits of continuous manufacturing in the production of bio/pharmaceuticals have been well publicized as have the challenges in implementing these and other new technologies in the production of biopharmaceuticals. This presentation...

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CMC Strategy Forum

Title: CMC Strategy Forum Location: Gaithersburg, MD Link out: Click here Description: Joseph Siemiatkoski, Consultant at BPTC will be attending the CMC Strategy Forums “Emerging Strategies in Drug Product Comparability and Process Validation” and “Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” during the CaSSS CMC Strategy Forum -Summer 2016...

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