For the pharmaceutical industry to respond faster and safer to the next health crisis, one thing is certain, drug developers need a strong, detailed, forward-thinking regulatory strategy.Read More
Marc Pelletier, PhD
Marc Pelletier, PhD is an internationally-recognized biopharmaceutical process specialist. An industry leader in the area of fermentation and cell culture based bioprocesses, Marc has helped to revolutionize the way single-use systems are used in the biopharmaceutical industry. While his primary expertise is in upstream and downstream unit operations, Marc also has extensive experience in the area of plasma fractionation. Additionally, his knowledge extends beyond unit operations to facility & process equipment design, process development & technology transfer, commissioning & qualification (C&Q); such proficiency offers practical application when he provides consulting to assist biopharmaceutical manufacturers achieve regulatory compliance in cGMP clinical and commercial production facilities. The processes and facilities that he has designed include those for the manufacture of vaccines, mAbs and small molecule therapeutics. Marc has been a pioneer in risk-based approaches to systems and process validation, most recently developing a tool allowing for assessment of closed systems.
Although Marc is formally educated as a biochemist, he has worked as a process engineer the majority of his 25+ year career. His contribution to the life sciences sector has been focused on the food and biopharmaceutical industries. Prior to consulting, Marc spent much of his time developing biotech-based processes for commercial production of biologics, blood products, nutraceuticals and food additives. He has played the role of project manager, process design lead, equipment designer, facility programmer, risk assessment moderator and validation manager on these projects.
He is currently the vice-chair of the ASME BPE. He is a contributing advisor to the BPOG Room De-Classification Team and is a co-author of the recently revised ISPE Biopharmaceutical Manufacturing Facilities Baseline Guide. His chapters focused on closed processing and the potential risks and impact on biopharmaceutical facility design. With the ISPE, BPOG and ASME BPE, he is leading the charge to harmonize the biotechnology industry’s lexicon for sanitary and aseptic bioprocessing operations. He has also authored a CIP and SIP Best Practices Guide for his biopharmaceutical clients. Marc has served as adjunct professor at the University of Manitoba, Canada and Bemidji State University, MN. He is a frequent lecturer for the AAPS, ASME, IBC and ISPE.