title: Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments.
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.
authors.affiliation: Banc de Sang i Teixits, Barcelona, Spain. Electronic address: jvives@bst.cat.
authors.forename: Joaquim
authors.initials: J
authors.lastname: Vives
authors.affiliation: Banc de Sang i Teixits, Barcelona, Spain.
authors.forename: Irene
authors.initials: I
authors.lastname: Oliver-Vila
authors.affiliation: Banc de Sang i Teixits, Barcelona, Spain.
authors.forename: Arnau
authors.initials: A
authors.lastname: Pla
mesh_terms: D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D006801:Humans; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D059630:Mesenchymal Stem Cells / Q000166:cytology; D011786:Quality Control
keywords: Good Laboratory Practices; Good Manufacturing Practices; cell-based therapeutics; product development; quality compliance