The Quality Management Ecosystem in Cell Therapy in Catalonia (Spain): An Opportunity for Integrating Standards and Streamlining Quality Compliance

Abstract

Integrated management system; Quality compliance; Quality standards

Sistema de gestión integrado; Cumplimiento de la calidad; Estándares de calidad

Sistema de gestió integrat; Compliment de la qualitat; Estàndards de qualitat

Cell therapies are required to meet with compulsory regulations that co-exist with other optional standards and guidelines that together compose a complex quality management system. Indeed, reliable insights on the mechanisms of action and safety of novel cell-based therapies require adherence to solid quality management structures in all steps of the value chain, from early research and tissue procurement to clinical trials and biovigilance, thus guaranteeing reproducibility and solid foundations for better science and improved clinical practice. Herein we present the concept of the quality ecosystem as a tool to understand and assist all stakeholders involved in developing and structuring the integration of standards as novel developments are taking place. We conclude that the various quality management initiatives can all be thought about under the umbrella of an ecosystem.

Work in JV’s laboratory is supported by the Spanish Advanced Therapy Network (TERAV, expedient No. RD21/0017/0022), awarded by the Generalitat de Catalunya as Consolidated Research Group (ref. 2017SGR719) and funded by Ministerio de Ciencia Innovación y Universidades de España (Instituto de Salud Carlos III, expedient No. PI19/01788).