Journal
CYTOTHERAPY
Volume 17, Issue 8, Pages 1009-1014Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.jcyt.2015.02.002
Keywords
cell-based therapeutics; Good Laboratory Practices; Good Manufacturing Practices; product development; quality compliance
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Along with academic and charitable organizations, transfusion centers have ventured into the stem cell field, with the aim of testing of novel cell-based therapeutics in a clinical setting for future marketing approval. The fact that quality management structures, which are required for compliance with good scientific practice regulations, were originally designed for product development in corporate environments represents a major challenge for many developers. In this Commentary, challenges that non-pharmaceutical institutions must overcome to translate cell-based products into clinical therapies will be discussed from a quality standpoint. Furthermore, our development experience for a mesenchymal stromal cell based therapy will be shared as a case study.
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