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GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells

Pharmaceutical Manufacturing: Regulations and Quality

  1. Eva Rohde,
  2. Katharina Schallmoser,
  3. Christina Bartmann,
  4. Andreas Reinisch,
  5. Dirk Strunk

Published Online: 15 MAR 2010

DOI: 10.1002/9780470571224.pse377

Pharmaceutical Sciences Encyclopedia

Pharmaceutical Sciences Encyclopedia

How to Cite

Rohde, E., Schallmoser, K., Bartmann, C., Reinisch, A. and Strunk, D. 2010. GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells. Pharmaceutical Sciences Encyclopedia. 4:1–20.

Author Information

  1. Medical University of Graz, Graz, Austria

Publication History

  1. Published Online: 15 MAR 2010

Abstract

U.S. regulations demand that tests for potency shall consist of either in vitro or in vivo tests, or both. These tests should be designed specifically for each product so as to indicate its potency in a manner adequate to satisfy the interpretation of potency given by the definition in 21 CFR 600.3(s). This article demonstrates that rapid and standardized expansion of human mesenchymal stromal cells (MSCs) to achieve a reasonable cell dose is feasible within less than four weeks and replacing fetal bovine serum (FBS) with human platelet lysate (HPL) provides one strategy toward a safer cell-based medicinal product (CBMP).

Keywords:

  • mesenchymal stromal cells (MSCs);
  • fetal bovine serum (FBS);
  • human platelet lysate (HPL);
  • cell-based medicinal products (CBMP);
  • potency