Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production

Feb 2018
PDA Item Number
Hardcover: 17346 | Digital: 18042
Member Price
Nonmember Price

This book provides succinct and practical guidance on how to develop a biological drug product and, at the same time, stay within the regulatory expectations at each phase of the development process!

Within this book, you can find chapters on:

  • Current manufacturing and process development of Regenerative Medicine Advanced Therapy Products (RMATs), or as they are known in the EU, Advanced Therapy Medicinal Products (ATMPs)
  • Quality systems and GMP requirements for Phase 1 to Phase 3 manufacturing
  • The impact of the Clinical Trials Directive on European GMP expectations and the role of the QP
  • The latest USP guidance on the transfer of analytical methods, validation and verification of compendial procedures
  • And, much more

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

  1. Introduction by Trevor Deeks
  2. What is Phase Appropriate GMP? The Regulatory Background and Current Expectations by Trevor Deeks
  3. Impact of the EU Clinical Trials Directive and the Role of the QP by Mark Slattery
  4. Systems and System Integrity in the Analytical Laboratory by Siegfried Schmitt
  5. Phase Appropriate GMP in the Laboratory by John Duguid
  6. Phase-Based Approach to Quality Assurance in Pharmaceutical Manufacturing — Big Pharma Perspective by David Grote
  7. Phase Appropriate cGMPs: The Virtual Company by Paul Steiner and Trevor Deeks
  8. Deviations, Change Control, Process Improvements by Sue Schniepp
  9. Creating a Culture and System for Learning when using a Phase Appropriate Model by James Vesper
  10. Cell Line Characterization by Sandra K. Dusing, Kathy Martin Remington, Marian L. McKee, and Audrey Chang
  11. Considerations for Viral Clearance Studies by Kathryn Martin Remington and Kate Smith
  12. The Impact of Single-use Systems on the Application of Phase Appropriate GMP in Bioprocessing by Trevor Deeks and Jeff Blake
  13. Regenerative Medicine Advanced Therapies: Phase Appropriate Good Manufacturing Practices by Gary C. du Moulin
  14. Microbiological Control and Testing for Phase Appropriate GMP by Tim Sandle
  15. The Evolution of Process Validation by Karen Zink McCullough
  16. Sterility Assurance in Early Phase Development by Tim Sandle

About the Authors

About the Author

Trevor Deeks, Ph.D. has 38 years of experience in pharmaceutical development, manufacturing, quality control and quality assurance. He is registered as an eligible QP under EC Directive and has also practiced as a registered Pharmacist in the UK. He now resides in Maryland and has his own consulting business. He has a Ph.D. in Peptide Chemistry and has extensive expertise in aseptic processing and a wide range of unique and unusual biotechnology processes, including live vaccines, tissue culture products, and cellbased products, working with many of the top 20 Global Pharma and Biopharma companies. He has held a number of senior management positions in Quality and in Process and Analytical Development.

He has practiced as a QP since 1983 and his QP experience includes commercial batch release, investigational medicinal products and "Specials". He has established and operated Quality Systems in compliance with the European Clinical Trials Directive and with global regulatory expectations (FDA, WHO, ANVISA, etc.). He has led scale-up and technology transfer projects for large and small molecules, has managed many projects with contract manufacturing organizations, has undertaken a number of evaluations of new technologies, and has performed due diligence evaluations of such products for acquisition.