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
Senior Fellow - Bioprocess Design & Risk Assessment
Marc Pelletier is an internationally-recognized biopharmaceutical process specialist. Marc’s experience and knowledge extends beyond unit operations to facility and process equipment design, process development and technology transfer, and regulatory compliance in cGMP clinical and commercial production facilities. The processes and facilities that he has designed include those for the manufacture of ATMPs, 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 the assessment of closed systems.
Although Marc is formally educated as a biochemist, he has worked as a process engineer for the majority of his 35+ year career. His contribution to the life sciences sector has been focused on the food and biopharmaceutical industries. He is an active member of the ASME BPE Standards Committee and recipient of the ASME Legacy Award. He is a strong contributor to the BioPhorum where he co-authored multiple white papers including his “Death to Cleanrooms” treatise. He is a co-author of the 2nd and 3rd editions of the ISPE Biopharmaceutical Manufacturing Facilities Baseline Guide. He has also authored CIP and SIP Best Practices Guides. With the ISPE, BioPhorum and ASME BPE, he is leading the charge to harmonize the biotechnology industry’s lexicon for sanitary and aseptic bioprocessing operations and closed systems.