Formulation of Cell-Based Medicinal Products: A Question of Life or Death?
(Non)-off-the shelf
Advanced therapy medicinal products
Biopharmaceuticals
Cell therapy products
Cell-based medicinal products
Excipients
Formulation
Fresh
Frozen
Stability
Journal
Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
received:
26
05
2020
revised:
23
06
2020
accepted:
06
07
2020
pubmed:
11
7
2020
medline:
11
7
2020
entrez:
11
7
2020
Statut:
ppublish
Résumé
The formulation of cell-based medicinal products (CBMPs) poses major challenges because of their complexity, heterogeneity, interaction with their environment (e.g., the formulation buffer, interfaces), and susceptibility to degradation. These challenges can be quality, safety, and efficacy related. In this commentary we discuss the current status in formulation strategies of off-the-shelf and non-off-the-shelf (patient-specific) CBMPs and highlight advantages and disadvantages of each strategy. Analytical tools for the characterization and stability assessment of CBMP formulations are addressed as well. Finally, we discuss unmet needs and make some recommendations regarding the formulation of CBMPs.
Identifiants
pubmed: 32649938
pii: S0022-3549(20)30364-6
doi: 10.1016/j.xphs.2020.07.002
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1885-1894Informations de copyright
Copyright © 2020 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.