학술논문
Recommendations for procurement of starting materials by apheresis for advanced therapy medicinal products.
Document Type
Article
Author
Manson, Lynn; Barry, Jacqueline; Fong, Chris; Potok, Davina; Sweeny, Di; Reeks, Dominic; Watson, Douglas; Hope, Drew; Piccinini, Elia; Cui, Haili; Keane, Helen; Armstrong, Jennifer; Sinclair, Joy; Guest, Julie; Chuku, Justina; Kerr, Maria; Francis, Natalie; Bell, Neil; Smith, Richard; Angelica, Rita
Source
Subject
*PRODUCT quality
*HEMAPHERESIS
*ACCREDITATION
*SUPPLY chains
*
*
*
Language
ISSN
1465-3249
Abstract
Activities involved in the production of certain advanced therapy medicinal products (ATMPs) require standardized approaches to mononuclear cell procurement to ensure the highest product quality, safety and process efficiency. These aims must be achieved while meeting regulatory and accreditation requirements for the procurement of mononuclear cells as starting materials. Mononuclear cells constitute the starting materials for many ATMPs, and this article sets out recommendations for procurement by clinical apheresis, addressing the variation among existing working practices and different manufacturers' requirements that currently poses a challenge when managing multiple different protocols. [ABSTRACT FROM AUTHOR]