Formulation of Cell-Based Medicinal Products: A Question of Life or Death?

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....

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2021-05, Vol.110 (5), p.1885-1894
Main Authors: Hoogendoorn, Karin H., Crommelin, Daan J.A., Jiskoot, Wim
Format: Article
Language:English
Subjects:
(Non)-off-the shelf
Advanced therapy medicinal products
Biopharmaceuticals
Cell therapy products
Cell-based medicinal products
Excipients
Formulation
Fresh
Frozen
Stability
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Summary: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.
ISSN:0022-3549
1520-6017
DOI:10.1016/j.xphs.2020.07.002