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Cell culture media: An active pharmaceutical ingredient or ancillary material?

Abstract:

Cell culture media are used to manufacture cell-based therapies. A number of essential materials are involved in the manufacture of cellbased therapies, including the active pharmaceutical ingredient (API), ancillary materials (AMs), and raw materials (RMs). Regulatory measures are needed to ensure the safety and quality of AMs and RMs used — measures that differ from those used for APIs. Although current regulatory guidelines exist for RMs, they are limited in certain aspects. In addition, s...

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Publication status:
Published
Peer review status:
Peer reviewed
Version:
Accepted Manuscript

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Authors


Alturkistani, A More by this author
More by this author
Institution:
University of Oxford
Division:
Medical Sciences
Department:
Paediatrics
More by this author
Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
Paediatrics
ORCID:
0000-0003-2484-3347
More by this author
Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
Paediatrics
Publisher:
Informa Life Sciences Group Publisher's website
Journal:
BioProcess International Journal website
Volume:
16
Issue:
9
Pages:
E3
Publication date:
2018-09-27
Acceptance date:
2018-09-24
EISSN:
1945-7065
ISSN:
1542-6319
Pubs id:
pubs:924783
URN:
uri:fe30ae78-e901-4d3b-9512-8faa06d686ff
UUID:
uuid:fe30ae78-e901-4d3b-9512-8faa06d686ff
Local pid:
pubs:924783

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