Failing to plan is planning to fail: the case for early use of cGMP raw materials
Insufficient planning, in the early stages of mAbs scale-up, results in an inefficient process at best, or validation failures leading to serious market delays at worst. Using cGMP grade reagents earlier in the transition to large-scale commercial manufacturing makes for a seamless transition — maintaining quality and viability while avoiding additional costs, potential process re-development and lost production time.
This fact sheet provides an in-depth overview of the advantages to including cGMP raw materials earlier in the scale-up process — and what a game-changer early use can be.
Author
Beth Kroeger-Fahnestock
Director, New Product Introduction at Avantor
Beth Kroeger-Fahnestock is a Director, New Product Introduction, in Avantor’s Biopharma Production division. She currently manages new product launches to support Avantor’s mission in bringing lifesaving medicines to market. She has extensive industry experience in Manufacturing, Validation, Technical Transfer, R&D, Compliance, and Quality from her various positions she has held. Her areas of expertise include large-scale Bioprocess systems, downstream purification operations, and process and cleaning validation along with cleanroom environmental control, speaking frequently on these topics for educational and professional organizations. She served on the ISPE task force responsible for writing the ISPE Guidance: Cleaning Validation Lifecycle – Applications, Methods, and Controls Good Practice Guide, published in 2020 and was an Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program for several years. She earned a B.S. in Biochemistry from the University of Missouri, St. Louis.