Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents
Clara Sanz‐Nogués, Timothy O’Brien
Abstract
Producing human mesenchymal stromal cells (MSCs) for clinical use requires adherence to current good manufacturing practice (cGMP) standards. This is necessary for ensuring standardization and reproducibility through the manufacturing process, but also, for product quality and safety. However, the large-scale production of clinical-grade MSCs possesses unique regulatory challenges and hurdles related to the heterogeneous nature of MSC cultures as well as the complex manufacturing process. Following is a compilation of the major issues encountered in the manufacturing of MSCs for clinical use, and our views on the optimal characteristics of the final MSC product.
Topics & Concepts
Good manufacturing practiceMesenchymal stem cellStandardizationProduct (mathematics)Manufacturing processClinical PracticeQuality (philosophy)Process (computing)Manufacturing engineeringRisk analysis (engineering)Production (economics)Stromal cellComputer scienceMedicineBusinessProcess managementEngineeringOperations managementCancer researchPathologyMaterials scienceMacroeconomicsEconomicsFamily medicineMathematicsEpistemologyOperating systemComposite materialGeometryRegulatory affairsPhilosophyMesenchymal stem cell researchTissue Engineering and Regenerative MedicineCancer Cells and Metastasis