Abstract
Background aims
Mesenchymal stromal cells (MSC) have gained prominence in the field of regenerative
medicine due to their excellent safety profile in human patients and recently demonstrated
efficacy in late-stage clinical studies. A prerequisite to achieving successful MSC-based
therapies is the development of large-scale manufacturing processes that preserve
the biological potency of the founder cell population. Because no standardized manufacturing
process exists for MSCs, understanding differences in these processes among U.S. academic
facilities would allow for better comparison of results obtained in the clinical setting.
Methods
We collected information through a questionnaire sent to U.S. academic centers that
produce MSCs under Good Manufacturing Practice conditions.
Results
The survey provided information on the number and geographic location of academic
facilities in the United States and major trends in their manufacturing practices.
For example, most facilities employed MSCs enriched from bone marrow by plastic adherence
and expanded in media supplemented with pooled human platelet lysate. Sterility testing
and product identification via cell surface phenotype analysis were commonly reported
practices, whereas initial and working cell plating densities, culture duration, product
formulation and the intended use of the MSC product were highly variable among facilities.
The survey also revealed that although most facilities assessed product potency, the
methods used were limited in scope compared with the broad array of intended clinical
applications of the product.
Conclusions
Survey responses reported herein offer insight into the current best practices used
to manufacture MSC-based products in the United States and how these practices may
affect product quality and potency. The responses also provide a foundation to establish
standardized manufacturing platforms.
Key Words
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Article info
Publication history
Published online: June 07, 2019
Accepted:
April 3,
2019
Received:
February 15,
2019
Identification
Copyright
© 2019 International Society for Cell and Gene Therapy. Published by Elsevier Inc. All rights reserved.
