9ee701d550ee4140fc382e7cc64d4c85 pmc_9265754.pdf bbfd6ecfa0fb948f90f227f47316e7cd724b68c3 pmc_9265754.pdf 2faca73dafd3769ca3bdcd634476fc9cadcb238a5378d7305bab9bf9e21ffa27 pmc_9265754.pdf Title: The Quality Management Ecosystem in Cell Therapy in Catalonia (Spain): An Opportunity for Integrating Standards and Streamlining Quality Compliance Subject: 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. Keywords: cell therapy; quality standards; quality compliance; JACIE; GMP; ISO9001; FACT; NetCord; AABB; integrated management system Author: Joaquim Vives, Maria Glòria Sòria, Eoin McGrath and Mara Magri Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Tue Jul 5 05:00:34 2022 CEST ModDate: Fri Jul 8 09:52:25 2022 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 10 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 266266 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- HOVDKQ+URWPalladioL-Bold Type 1 Custom yes yes no 10 0 LYVDPP+URWPalladioL-Roma Type 1 Custom yes yes no 15 0 PMNUYY+URWPalladioL-Ital Type 1 Custom yes yes no 19 0 PHHTYQ+VnURWPalladioL Type 1 Custom yes yes no 23 0 WLFTRW+VnURWPalladioL-Bold Type 1 Custom yes yes no 28 0 PFKOHU+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 46 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2024-05-17 03:29:45 CEST RepresentationInformation: pmc_9265754.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2024-05-17 02:37:59 CEST Size: 266266 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 176 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Quality Standards in Cell Therapy Destination: section.2 Item: Title: The Concept of the Ecosystem of Quality Standards Destination: section.3 Item: Title: The Quality Management Ecosystem of Cellular Immunotherapy Destination: section.4 Item: Title: Case Study Destination: section.5 Children: Item: Title: Pioneers and Primary Succession Destination: subsection.5.1 Item: Title: Secondary Succession Destination: subsection.5.2 Item: Title: Outlook Destination: section.6 Item: Title: References Destination: section.6 Info: Title: The Quality Management Ecosystem in Cell Therapy in Catalonia (Spain): An Opportunity for Integrating Standards and Streamlining Quality Compliance Author: Joaquim Vives, Maria Glòria Sòria, Eoin McGrath and Mara Magri Subject: 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. 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