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Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.
The International Society for Pharmaceutical Engineering (ISPE) announced in a Dec. 9, 2021 press release that it had released a new guide for development and design of manufacturing facilities for advanced therapy medicinal products (ATMPs). The “ISPE Guide: ATMPs–Autologous Cell Therapy,” focuses on autologous cell therapies while providing content that may be applicable to other types of ATMPs.
ATMP therapies include cells, engineered tissues, or the manipulation of the patient’s genome, and these emerging therapies use rapidly evolving technology and equipment, ISPE said in the press release.
“The growing number of autologous products that are entering the pipeline is evidence to the growth potential of this therapeutic approach,” said Guide Lead Jeff Odum, CPIP, NCBiosource. “Science has promised this for years; it is now delivering on the promise, and it gives new promise and hope to patients that have rare conditions or diseases. It is a game-changer. The product-process relationship for ATMPs is very different from the traditional cell culture-based approach that most people are familiar with. Because the ATMP space has its roots in the academic/hospital environment in a much smaller scale, the application of [good manufacturing practices] to the overall manufacturing operations is a different challenge.”