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.
Key Words
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Article info
Publication history
Published online: July 12, 2016
Accepted:
May 13,
2016
Received:
April 5,
2016
Identification
Copyright
© 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.
