BioPharm International - September 2022

BioPharm International - September 2022

Issue link:

Contents of this Issue


Page 14 of 37

14 BioPharm International ® Emerging Therapies 2022 eBook T he rapid growth of the cell and gene therapy (CGT) industry has highlighted a need for more universally accepted definitions and processes involving chain of identi- ty (COI) and chain of custody documentation for raw materials. Current good documentation prac- tices (CGDP) exist and are enforced by regulatory bodies, but large differences remain in how these practices are implemented across the industry. What's more, diverse protocol operations cause chal- lenges with individual practices. The industry must take steps to improve documenta- tion integrity and standardize when possible to reduce risk. Errors can lead to manufacturing holds and delays or, worse, cause a negative outcome for a patient. Documentation integrity is fundamental to health- care and critical for the successful manufacturing of cellular starting material. Standardization is not easy or quick, however, and customization will be needed in some situations. Until standardization occurs, ensuring a system for real-time post-apheresis raw material documen- tation and labeling review prior to release can reduce delays to manufacturing and increase document and labeling integrity. Neccesity of real-time documentation and labeling review Document and labeling integrity—meaning the doc- ument or label is completed per the set requirements and is legible and accurate—can be difficult to achieve because of the variability in processes, protocols, doc- uments, and standard operating procedures. A l l centers t hat col lect a l logeneic a nd autolo- gous starting material will have individual quality systems that outline the expectations within that system. CGT sponsors or manufacturers may have t heir ow n qua lit y systems by wh ich a col lecting center must abide. T hese va r y i ng s ystems of ten are not the same, and a center may be collecting for Real-Time Post-Apheresis Documentation Decreases Errors Julie Tilbury, is a collection network liaison at Be The Match BioTherapies. Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing. GREENBUTTERFLY - STOCK.ADOBE.COM

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm International - September 2022 - BioPharm International - September 2022