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

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 so...

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Bibliographic Details
Published in:Cells (Basel, Switzerland) Switzerland), 2022-07, Vol.11 (13), p.2112
Main Authors: Vives, Joaquim, Sòria, Maria Glòria, McGrath, Eoin, Magri, Mara
Format: Article
Language:English
Subjects:
Accreditation
Biodiversity
Cell therapy
Clinical trials
Ecosystem management
Ecosystems
Evolution
Genetic engineering
GMP
Good Manufacturing Practice
Hematology
Immunotherapy
ISO9001
JACIE
Leukemia
Lymphocytes
Patient safety
quality compliance
Quality management
quality standards
Stem cells
Transplants & implants
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Summary: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.
ISSN:2073-4409
2073-4409
DOI:10.3390/cells11132112