NextGen now - Delivering tomorrow’s facilities today

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.

Ryan McDonough is a forging thought leader in the biotech industry who is currently leading the biotechnology market sector at CRB and spearheading the development and progression of the Advanced Therapy Medicinal Product (ATMP)/cell and gene therapy initiative at CRB. McDonough has worked with clients on multiprocess facilities predicated on maximum flexibility, logistics optimization and technologies that reduce overhead costs, allow pipeline expandability and produce a higher quality therapeutic—all with the purpose of creating lifesaving therapies and cures.

McDonough has a strong technical background in process design for biopharmaceutical manufacturing facilities and spent much of his early career performing both engineering design and project management. Twenty years of progressive experience, has provided him with in-depth knowledge of the design, construction and qualification requirements necessary for delivering integrated ONEsolution™ projects. Aside from his technical proficiency, McDonough possesses a unique ability to thoroughly understand the financial implications and business impacts of facility design choices and acts as a steward to clients, assisting with the best decisions for their business and bottom line.

McDonough is an active board member of the Joel Anthony Gingras (JAG) Jr. Memorial Foundation, which focuses on fundraising for brain tumor research and increasing public awareness.