title: 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 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.
authors.affiliation: International Society for Cellular Therapy Process and Product Development Subcommittee, USA; Charter Medical, Ltd., Winston-Salem, North Carolina, USA. Electronic address: dclarke@chartermedical.com.
authors.forename: Dominic
authors.initials: D
authors.lastname: Clarke
authors.affiliation: Johnson & Johnson, Philadelphia, Pennsylvania, USA.
authors.forename: Jean
authors.initials: J
authors.lastname: Stanton
authors.affiliation: Janssen Supply Chain, Spring House, Pennsylvania, USA.
authors.forename: Donald
authors.initials: D
authors.lastname: Powers
authors.affiliation: International Society for Cellular Therapy Process and Product Development Subcommittee, USA; Karnieli Ltd, Tivon, Israel.
authors.forename: Ohad
authors.initials: O
authors.lastname: Karnieli
authors.affiliation: Pluristem Therapeutics, Haifa, Israel.
authors.forename: Sagi
authors.initials: S
authors.lastname: Nahum
authors.affiliation: International Society for Cellular Therapy Process and Product Development Subcommittee, USA; Lonza Walkersville, Inc., Walkersville, Maryland, USA.
authors.forename: Eytan
authors.initials: E
authors.lastname: Abraham
authors.affiliation: International Society for Cellular Therapy Process and Product Development Subcommittee, USA; Aseptic Technologies, Les Isnes, Belgium.
authors.forename: Jean-Sebastien
authors.initials: JS
authors.lastname: Parisse
authors.affiliation: International Society for Cellular Therapy Process and Product Development Subcommittee, USA; Stem Cell Group, Bioprocessing Technology Institute, Centros, Singapore.
authors.forename: Steve
authors.initials: S
authors.lastname: Oh
mesh_terms: D018929:Cell Culture Techniques / Q000379:methods; D064987:Cell- and Tissue-Based Therapy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D052638:Particulate Matter; D061214:Patient Safety; D011786:Quality Control; D018570:Risk Assessment
chemical_list: D052638:Particulate Matter
keywords: cell therapy; disposable; injectable; parenteral; particle; particulate