Expert-driven guidance for scalable, compliant cell therapy manufacturing
As cell therapies continue to reshape modern medicine, manufacturers face new challenges in selecting and qualifying equipment for GMP production. The newly released ISPE Good Practice Guide: ATMPs – Equipment Design and Qualification for Cellular Products provides practical, expert-driven guidance to help address these challenges - particularly in aseptic processing, automation, in-process testing and scalability.
PM Group’s Charles Heffernan, co-chair of the guide, commented: “This is an industry first. I was honored to work alongside such a dedicated group of contributors to develop guidance that not only reflects today’s best practices but also anticipates the next generation of closed, automated, and cost-effective cell therapy manufacturing.”
The guide focuses on equipment used in autologous and allogeneic therapies, providing actionable recommendations aligned with global regulatory frameworks. It’s intended to support both manufacturers evaluating new technologies and vendors developing scalable solutions.
The guide is available for download via ISPE’s E-Reader platform
Learn more from Charles about the challenges of ATMP design
