Proposal for the International Society for Cell & Gene Therapy position statement on assays for the quality control and potency assessment of adoptive cellular immunotherapies.
Biological Assay
/ standards
Cell- and Tissue-Based Therapy
/ methods
Chromosomal Instability
/ genetics
DNA Fingerprinting
/ standards
Drug Approval
/ methods
Flow Cytometry
/ standards
Genetic Therapy
/ methods
Graft vs Host Disease
/ prevention & control
Hematologic Tests
/ standards
Histocompatibility Testing
/ standards
Humans
Immunotherapy, Adoptive
/ methods
International Cooperation
Laboratories
/ standards
Quality Control
Terminology as Topic
Transplantation, Homologous
Quality control
in-process QC
quality assurance
release assays
Journal
Cytotherapy
ISSN: 1477-2566
Titre abrégé: Cytotherapy
Pays: England
ID NLM: 100895309
Informations de publication
Date de publication:
03 2019
03 2019
Historique:
received:
15
11
2018
revised:
06
02
2019
accepted:
06
02
2019
pubmed:
21
3
2019
medline:
25
2
2020
entrez:
21
3
2019
Statut:
ppublish
Résumé
Translation of cell and gene therapies from pre-clinical experiments to clinical trials and final drug licensing brings requires the development, verification and even validation of the assays essential for the definition of the drug product. The technical and scientific challenges in doing this are far greater than they seem at first and are compounded by a lack of approved standards for assays used to support (c)GMP manufacture. This paper highlights some of those challenges and proposes solutions based on the experience of our colleagues using similar assay platforms in regulated pathology laboratories.
Identifiants
pubmed: 30890307
pii: S1465-3249(19)30005-2
doi: 10.1016/j.jcyt.2019.02.001
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
367-375Commentaires et corrections
Type : ErratumIn
Informations de copyright
Copyright © 2019 International Society for Cell and Gene Therapy. All rights reserved.