Journal article icon

Journal article

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...

Expand abstract
Publication status:
Published
Peer review status:
Peer reviewed

Actions


Authors


More by this author
Institution:
University of Oxford
Division:
Medical Sciences
Department:
Paediatrics
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Paediatrics
Role:
Author
ORCID:
0000-0003-2484-3347
More by this author
Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
Paediatrics
Role:
Author
Publisher:
Informa Life Sciences Group
Journal:
BioProcess International More from this journal
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
UUID:
uuid:fe30ae78-e901-4d3b-9512-8faa06d686ff
Local pid:
pubs:924783
Source identifiers:
924783
Deposit date:
2018-10-08

Terms of use


Views and Downloads






If you are the owner of this record, you can report an update to it here: Report update to this record

TO TOP