Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2171004 | Cytotherapy | 2016 | 14 Pages |
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.
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Authors
Dominic Clarke, Jean Stanton, Donald Powers, Ohad Karnieli, Sagi Nahum, Eytan Abraham, Jean-Sebastien Parisse, Steve Oh,