Real-Time Post-Apheresis Documentation Decreases Errors

BioPharm International, BioPharm International, Emerging Therapies September 2022, Volume 2022 eBook, Issue 3
Pages: 14–16

Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.

There is a need for more universally accepted definitions and processes involving chain of identity and chain of custody documentation for raw materials used in cell and gene therapies. Although current good documentation practices exist and are enforced by regulatory bodies, there is a vast discrepancy in how these practices are implemented across the industry. The industry must take steps to improve documentation integrity and standardize to reduce risk. Until standardization occurs, it will be difficult to ensure a system for raw material documentation.

Read this article in BioPharm International’s September 2022 Emerging Therapies 2022 eBook.

About the author

Julie Tilbury is a collection network liaison at Be The Match BioTherapies.

Article Details

BioPharm International
eBook: Emerging Therapies 2022, September 2022
September 2022
Pages: 14–16

Citation

When referring to this article, please cite it as J. Tilbury, “Real-Time Post-Apheresis Documentation Decreases Errors," BioPharm International Emerging Therapies 2022 eBook (September 2022).