New Guide Tackles Best Practices for Making Allogeneic Cell Therapies
Erich Bozenhardt, Associate Director of Process Engineering and Therapeutics for United Therapeutics, an active ISPE member, and close collaborator on the ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy, has participated in an interview with Cell & Gene in which he shares insights on the new ISPE Guide. In the interview, Bozenhardt touches on the current state of manufacturing standards for allogeneic cell therapies, key differences between allogeneic advanced therapy medicinal products (ATMPs) and a typical aseptically manufactured biologic, and how the ISPE Guide approaches de-risking for more risk-heavy steps such as downstream during fill/finish.
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Cell & Gene delivers in-depth content about cell and gene therapies from experienced professionals in the field. This publication focuses exclusively on this segment of the life sciences industry.