Managing particulates in cell therapy: Guidance for best practice

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 int...

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Bibliographic Details
Published inCytotherapy (Oxford, England) Vol. 18; no. 9; pp. 1063 - 1076
Main Authors Clarke, Dominic, Stanton, Jean, Powers, Donald, Karnieli, Ohad, Nahum, Sagi, Abraham, Eytan, Parisse, Jean-Sebastien, Oh, Steve
Format Journal Article
LanguageEnglish
Published England Elsevier Inc 01.09.2016
Subjects
Advanced Basic Science
Cell Culture Techniques - methods
cell therapy
Cell- and Tissue-Based Therapy - adverse effects
Cell- and Tissue-Based Therapy - methods
disposable
Humans
injectable
Other
parenteral
particle
particulate
Particulate Matter
Patient Safety
Quality Control
Risk Assessment
parenteral
injectable
particle
particulate
cell therapy
disposable
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Summary: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.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
content type line 23
ObjectType-Review-1
ISSN:1465-3249
1477-2566
DOI:10.1016/j.jcyt.2016.05.011