Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments

Joaquim Vives; Irene Oliver-Vila; Arnau Pla

doi:10.1016/j.jcyt.2015.02.002

Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments

Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10.

Authors

Joaquim Vives¹, Irene Oliver-Vila², Arnau Pla²

Affiliations

¹ Banc de Sang i Teixits, Barcelona, Spain. Electronic address: jvives@bst.cat.
² Banc de Sang i Teixits, Barcelona, Spain.

PMID: 25769789
DOI: 10.1016/j.jcyt.2015.02.002

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01227694 NCT01552707 NCT01605383.

Keywords: Good Laboratory Practices; Good Manufacturing Practices; cell-based therapeutics; product development; quality compliance.

Publication types

Review

MeSH terms

Cell- and Tissue-Based Therapy / methods*
Humans
Mesenchymal Stem Cell Transplantation / methods*
Mesenchymal Stem Cells / cytology
Quality Control

Associated data

ClinicalTrials.gov/NCT01227694
ClinicalTrials.gov/NCT01552707
ClinicalTrials.gov/NCT01605383