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Updated: Mar 17, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Managing particulates in cell therapy: Guidance for best practice
Dominic Clarke1, Jean Stanton2, Donald Powers3
1International Society for Cellular Therapy Process and Product Development Subcommittee, USA; Charter Medical, Ltd., Winston-Salem, North Carolina, USA.
Abstract:
The intent of this article is to provide guidance and recommendations to cell therapy product sponsors (including developers and manufacturers) and their suppliers in the cell therapy industry regarding particulate source, testing, monitoring and methods for control. This information is intended to help all parties characterize the processes that generate particulates, understand product impact and provide recommendations to control particulates generated during manufacturing of cell therapy products.

