4th Edition

Process Validation in Manufacturing of Biopharmaceuticals

Edited By Anurag Singh Rathore, Hal Baseman, Scott Rudge Copyright 2024
    410 Pages 55 Color & 50 B/W Illustrations
    by CRC Press

    410 Pages 55 Color & 50 B/W Illustrations
    by CRC Press

    The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA.

    Key Features:

    • Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals.
    • Includes case studies from the various industry leaders that demonstrate application of these concepts.
    • Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise.
    • Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples.

    Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.

    1. The Evolution of Modern Process Validation: Commentary on the U.S. Food and Drug Administration’s 2011 Guidance for Industry, Process Validation Principles and Practices
    2. Hal Baseman

    3. Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes
    4. Robert J. Seely and John Haury

    5. Process Characterization
    6. James E. Seely

    7. Scale-Down Models for Microbial and Mammalian Cell Culture Processes: Approaches and Applications
    8. Ravali Raju et al.

    9. Scale-Down Models for Purification Processes: Approaches and Application
    10. Arch Creasy et al.

    11. Principles of Quality Risk Management for Validation
    12. Tiffany Baker and Patrick Mains

    13. Lifespan Studies for Chromatography and Filtration Media
    14. Anurag S. Rathore and Gail Sofer

    15. Analytical Test Methods for Well-Characterized Biological and Biotechnological Products
    16. Nadine Ritter and John McEntire

    17. Adventitious Agents: Concerns and Testing for Biopharmaceuticals
    18. Raymond W. Nims et al.

    19. Biotech Facility Design for Validation
    20. Phil DeSantis

    21. Process Validation at Contract Manufacturing Organizations: Approaches, Incentives, Benefits, and Risks
    22. Maria Wik and Scott Rudge

    23. Validation of a Filtration Step
    24. Jennifer Campbell et al.

    25. Validation of Continuous Bioprocesses
    26. Marc Bisschops and Mark Schofield

    27. Role of Multivariate Analysis in Process Validation
    28. Anurag S. Rathore and Vishwanath Hebbi

    29. Process Development for Plasmid DNA Production
    30. Frank Agbogdo et al.


    ANURAG S. RATHORE is an Institute Chair Professor at the Department of Chemical Engineering, Indian Institute of Technology, Delhi, India. He is also the Coordinator for the DBT COE for Biopharmaceutical Technology. His areas of interest include process development, scale-up, technology transfer, process validation, biosimilars, continuous processing, medical image analysis, process analytical technology and quality by design. He is presently serving as the Editor-in-Chief of Preparative Biochemistry and Biotechnology and Associate Editor for Journal of Chemical Technology and Biotechnology. He also serves on the Editorial Advisory Boards for Biotechnology Progress, Biotechnology Journal, Electrophoresis, BioPharm International, Journal of Chromatography B, Journal of Chromatography Open, Pharmaceutical Technology Europe, and Separation and Purification Reviews. Dr. Rathore has edited books titled Preparative Chromatography for Separation of Proteins and Peptides (2017), Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Elements of Biopharmaceutical Production (2007), Process Validation (2005), Electrokinetic Phenomena (2004), and Scale-up and Optimization in Preparative Chromatography (2003). He has a Ph.D. in Chemical Engineering from Yale University.

    HAL BASEMAN is the Chief Operating Officer at ValSource Inc., a consulting services firm.  Hal has held various positions in the biopharmaceutical manufacturing and consulting industry and has been involved in sterile product manufacturing for over 45 years.  He is the past Chair of the PDA Board of Directors, the past Co-chair of PDA Science Advisory Board, past Chair or Lead on several PDA groups and efforts, including the PDA Process Validation Interest Group, the task forces for PDA Technical Reports on Process Validation, Aseptic Process Simulation, and Quality Risk Management, and the PDA Aseptic Processing Points to Consider.   He is currently a member of the PDA TRI (Training and Research Institute faculty, Co-lead for the Kilmer Conference Regulatory Innovation Collaboration team, Chair of the SfSAP (Society for Sterility Assurance Professionals) Aseptic Processing Team, and Co-chair of the PDA Annex 1 revision response team.  Hal has presented and published numerous articles and book chapters on topics related to sterile product manufacturing, risk management, and validation. He has edited books on Process Validation and Quality Risk Management. Hal holds a Bachelor of Science Degree in Biology from Ursinus College and a Master of Business Administration in Management from La Salle University.

    Dr. Scott Rudge is a Principal Consultant and a member of the Syner-G team since January 2023. He is an experienced pharmaceutical professional with 33 years of progressive experience directing Process Engineering, Process Development, Product Development and overall Pharmaceutical Operations. Scott was a co-founder of RMC Pharmaceutical Solutions in 2004, which was acquired by SynerG Biopharma Group in January, 2023. Scott has built and led several organizations in the biopharmaceutical industry, including process engineering, process development and product development teams at Synergen, Amylin Pharmaceuticals and FeRx, where he reported to the CEO. Ultimately, Scott formed his own consulting company, RMC Pharmaceutical Solutions with the vision to provide product development services to biotech and pharmaceutical companies of all sizes and all stages of development. Scott has remained active as a thought leader and innovator in biotechnology and pharmaceutical development. Scott is a co-author on the award winning textbook "Bioseparation Science and Engineering", co-author on the new chapter in Perry’s "Chemical Engineering Handbook" on Biotechnology, co-editor on the CRC "Process Validation in Manufacturing of Biopharmaceuticals", and has been a reviewer for the National Academy of Science’s ten year strategic goals for separation sciences in 2020, in addition to many publications and patents. Scott earned his B.S. in Chemical Engineering from Worcester Polytechnic Institute and his M.S. and Ph.D in Chemical Engineering from Purdue University.