CMO fusion: Where stainless steel meets disposable technology

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James Jim Stout

BioVectra Inc, Canada

: J Nephrol Ren Dis

Abstract

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With over 45 years of CDMO experience in Microbial Fermentation (small molecule), High Potency Linkers and Payloads, Conjugation, and PEGylation, BioVectra is embarking on a new challenge: Biologics! Rooted in our distinct and modern Microbial Biologics facility in Nova Scotia, Canada, we are near completion of an extensive and rapid facility retrofit. Attend this presentation to learn about the challenges we faced and how we overcame them. We will also highlight some of the innovation and strategy that has been built into the retrofit, including our cross-platform manufacturing trains, process operation adaptability (disposable & stainless), and streamlined process development by using modern E. coli expression systems in a hybrid-designed, tuneable scale, flexible facility. other tolerant and sensitive lines.

Biography

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James Jim Stout is the director, Process Science Biologics, BioVectra, Inc., jstout@biovectra.com, Responsible for all aspects of process development (USP & DSP), separation science, new technologies, scale-up & technology transfer, manufacturing support, and client technical interface. He has completed his Doctor of Philosophy in Chemistry from University of Cincinnati (1993). His Professional achievements includes : Staff Scientist Principal Scientist, Research/Process Development, Alexion Pharmaceuticals, Assistant/ Associate Director, Purification Development, Medarex, Inc., Group Leader, Purification Process Sciences, Abbott Bioresearch Center, Director, Amgen RI Purification Sciences, Process Development, Amgen Inc., Director of Process Science & Engineering, ImmunoGen, Inc,Vice President, Process Sciences, Natrix Separations, Inc.,

E-mail: jamesg_stout@hotmail.com