04481nam 2200613 450 991080627100332120200520144314.00-12-803116-6(CKB)3710000000450658(EBL)2110663(SSID)ssj0001562336(PQKBManifestationID)16206104(PQKBTitleCode)TC0001562336(PQKBWorkID)14833755(PQKB)11013178(MiAaPQ)EBC2110663(Au-PeEL)EBL2110663(CaPaEBR)ebr11081656(CaONFJC)MIL822709(OCoLC)915311598(PPN)192176870(EXLCZ)99371000000045065820150804h20162016 uy 0engur|n|---|||||txtccrGuide to cell therapy GxP quality standards in the development of cell-based medicines in non-pharmaceutical environments /Joaquim Vives, Gloria CarmonaAmsterdam, Netherlands :Academic Press,2016.©20161 online resource (279 p.)Description based upon print version of record.0-12-803115-8 Includes bibliographical references at the end of each chapters and index.Front Cover; Guide to Cell Therapy GxP; Copyright; Contents; List of Contributors; Foreword; Preface; 1 - Overview of the Development Program of a Cell-Based Medicine; 1. Introduction; 2. Key Pharmaceutical Factors to Consider in Early Development Stages; 3. TPP: Beginning with the End in Mind; 4. Stages of Drug Development; 5. Considering Stakeholders; 6. Product Lifecycle and Portfolio Management; 7. Performance Management and the Check Point Value; 8. Conclusions; References; Glossary; List of Acronyms and Abbreviations1. Introduction2. Types of Cell-Based Advanced Therapy Medicinal Products and their Safety Considerations; 3. Regulations and Nonclinical Studies; 4. Nonclinical Assessment-The Risk-Based Approach; 5. The Requirement for Good Laboratory Practice; 6. General Study Design Considerations; 7. Specific Nonclinical Safety Considerations; 8. Conclusions; References; Glossary; List of Acronyms and Abbreviations; 4 - Good Manufacturing Practice Compliance in the Manufacture of Cell-Based Medicines; 1. Outline of the Chapter; 2. Quality Management; 3. Documentation; 4. Qualification and Validation5. Premises and Equipment6. Personnel and Hygiene; 7. Manufacturing; 8. Quality Control; 9. Inspections, Audits, Complaints, Recalls, and Returns; 10. Conclusion; Acknowledgment; References; List of Abbreviations; 5 - Good Clinical Practice in Nonprofit Institutions; 1. Introduction; 2. The Elements of GCP Compliance; 3. The Clinical Trial Protocol; 4. The Investigator's Brochure; 5. The Informed Consent; 6. Essential Documents for Clinical Trial; 7. Clinical Trial Files; 8. Sponsor' Study Audit and Inspections; 9. Conclusion; References; Glossary; List of Acronyms and Abbreviations6 - Compatibility of GxP with Existing Cell Therapy Quality Standards1. Quality Standards in Cell Therapy; 2. Adaptation of Existing Standards to GxP; 3. Impact of GxP Implementation; 4. Quality by Design; 5. Recommendations for Optimizing Integration of QA Systems; 6. Conclusions; References; Glossary; List of Abbreviations; Index Guide to Cell Therapy GxP: Quality Standards in the Development of Cell-Based Medicines in Non-Pharmaceutical Environments provides a practical guide to the implementation of quality assurance systems for successful performance of all cell-based clinical trials. The book includes all information that should be used in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond, bridging the gap in knowledge with the inclusion of examples of design of GLP-compliant preclinical studies, design of bioprocesses for autologous/allogeneic theraCellular therapyBloodTransfusion, AutologousTreatmentCellular therapy.BloodTransfusion, AutologousTreatment.616.0277Vives Joaquim1676881Carmona GloriaMiAaPQMiAaPQMiAaPQBOOK9910806271003321Guide to cell therapy GxP4043368UNINA