Recommendations for procurement of starting materials by apheresis for advanced therapy medicinal products
Authors
Manson, L.Barry, J.
Fong, C.
Potok, D.
Sweeny, Di
Reeks, D
Watson, D.
Hope, D.
Piccinini, E.
Cui, H.
Keane, H.
Armstrong, J.
Sinclair, J.
Guest, J.
Chuku, J.
Kerr, M.
Francis, N.
Bell, N.
Smith, R.
Angelica, R.
Shingler, W.
Shingleton, W.
Turner, M.
Affiliation
Jack Copland Centre, Scottish National Blood Transfusion Service, Edinburgh, UKIssue Date
2022
Metadata
Show full item recordAbstract
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.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.Journal
CytotherapyDOI
10.1016/j.jcyt.2022.05.002PubMed ID
35710768Additional Links
https://dx.doi.org/10.1016/j.jcyt.2022.05.002Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.jcyt.2022.05.002
Scopus Count
Collections
Related articles
- [Requirements for long-term follow-up on efficacy and safety of advanced therapy medicinal products. Risk management and traceability].
- Authors: Klug B, Reinhardt J, Schröder C
- Issue date: 2010 Jan
- Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.
- Authors: Salmikangas P, Schuessler-Lenz M, Ruiz S, Celis P, Reischl I, Menezes-Ferreira M, Flory E, Renner M, Ferry N
- Issue date: 2015
- Advanced Therapy Medicinal Products and the Changing Role of Academia.
- Authors: Priesner C, Hildebrandt M
- Issue date: 2022 Jun
- The Current State of Advanced Therapy Medicinal Products in the Czech Republic.
- Authors: Kočí Z, Boráň T, Krůpa P, Kubinová Š
- Issue date: 2018 Sep
- European regulatory tools for advanced therapy medicinal products.
- Authors: Flory E, Reinhardt J
- Issue date: 2013 Dec