Recommendations for procurement of starting materials by apheresis for advanced therapy medicinal products
Manson, L. Barry, J. Fong, C. Potok, D. Sweeny, Di Reeks, D Watson, D. Hope, D. Piccinini, E. Cui, H.
Manson, L.
Barry, J.
Fong, C.
Potok, D.
Sweeny, Di
Reeks, D
Watson, D.
Hope, D.
Piccinini, E.
Cui, H.
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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.
Description
Date
2022
Publisher
Collections
Keywords
Type
Article
Citation
Manson L, Barry J, Fong C, Potok D, Sweeny D, Reeks D, et al. Recommendations for procurement of starting materials by apheresis for advanced therapy medicinal products. Vol. 24, Cytotherapy. Elsevier BV; 2022. p. 861–8.