Guide to Cell Therapy GxP - 1st Edition - ISBN: 9780128031155, 9780128031162

Guide to Cell Therapy GxP

1st Edition

Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments

Authors: Joaquim Vives Gloria Carmona
eBook ISBN: 9780128031162
Paperback ISBN: 9780128031155
Imprint: Academic Press
Published Date: 30th July 2015
Page Count: 266
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Description

Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond.  Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products.

Key Features

  • Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge
  • Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data
  • Includes practical examples of successful implementation of quality standards

Readership

Biomedical researchers; stem cell biologists; regenerative medicine researchers; clinical researchers and students in various medical areas using stem cells in their research

Table of 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
  • 2. European Regulatory Framework for the Development of Cell-Based Medicines
    • 1. Introduction
    • 2. What Cell-Based Products are Considered as Medicinal Products? The Legal Definitions and Main Regulations Applying to Cell-Based Products
    • 3. An Introduction to Cell-Based Medicine Development: Roadmap
    • 4. Regional and National Institutions Supporting Cell Therapy Translational Research
    • 5. European Regulation for Advanced Therapy Medicinal Products Not Intended to be Placed on the Market: Hospital Exemption and Its National Interpretation
    • 6. Conclusions
  • 3. Nonclinical Studies for Cell-Based Medicines
    • 1. Introduction
    • 2. 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
  • 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 Validation
    • 5. Premises and Equipment
    • 6. Personnel and Hygiene
    • 7. Manufacturing
    • 8. Quality Control
    • 9. Inspections, Audits, Complaints, Recalls, and Returns
    • 10. Conclusion
  • 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
  • 6. Compatibility of GxP with Existing Cell Therapy Quality Standards
    • 1. 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
  • Index

Details

No. of pages:
266
Language:
English
Copyright:
© Academic Press 2016
Published:
Imprint:
Academic Press
eBook ISBN:
9780128031162
Paperback ISBN:
9780128031155

About the Author

Joaquim Vives

Dr. Vives has specialties in GLP/GMP implementation, the development of (stem) cell-based products for regenerative medicine, and design, execution and analysis of non-clinical studies. He was a post-doctoral Fellow at University of Edinburgh and moved to Stem Cell Sciences Ltd in the UK where he became Head of Research. Six years ago, he became Head of Preclinical Studies at XCELIA, a biopharmaceutical company formed from The Catalan Blood and Tissue Service (Banc de Sang i Teixits) devoted to the development of advanced therapy medicine. As the Quality manager at XCelia, Dr. Vives secured the facility as the first GLP-compliant laboratory in Spain dedicated to the development of advanced cell therapies. He is now Director of R&D, responsible for technology transfer of innovative experimental bioprocesses into GMP-compliant production environments. He also manages GLP test facilities and relationships with Health Regulatory Agencies among other compliance responsibilities.

Affiliations and Expertise

R&D Director, XCELIA, Banc de Sang I Teixits, Barcelona, Spain

Gloria Carmona

Dr. Carmona is a Pharmacist with experience in management and training. She also holds a Masters Degree in Manufacturing of Advanced Therapy Medicinal Products and has worked across Europe in the biotechnology sector training on quality systems and good manufacturing practices in advanced therapies medicinal products. She has been a Quality Assessment Manager and GMP facilities Manager from the inception of the Andalusian Initiative for Advanced Therapies in October 2008. Previously, she worked worked as Quality Assessment and Accreditation Manager in the Andalusian Program for Cell Therapy and Regenerative Medicine. She has also worked as a Quality Assurance Technician at Cellerix an international biotech headquartered in Belgium, Cambridge, and Madrid and Clinical Documentation Technician in Pfizer.

Affiliations and Expertise

Quality Assessment and GMP facilities Manager, Andalusian Initiative for Advanced Therapies, Consejeria de Salud, Junta de Andalucia, Sevilla, Spain