Quality by Design for Biopharmaceutical Drug Product Development

  • Feroz Jameel
  • Susan Hershenson
  • Mansoor A. Khan
  • Sheryl Martin-Moe

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 18)

Table of contents

  1. Front Matter
    Pages i-xx
  2. Cyrus Agarabi, Mansoor A. Khan, Rakhi B. Shah
    Pages 1-15
  3. Ron Taticek, Jun Liu
    Pages 31-46
  4. Sheryl Martin-Moe, Carol Nast
    Pages 47-59
  5. Michael Siedler, Vineet Kumar, Ravi Chari, Sonal Saluja, Wolfgang Fraunhofer
    Pages 61-85
  6. Bernardo Perez-Ramírez, Nicholas Guziewicz, Robert Simler, Alavattam Sreedhara
    Pages 87-114
  7. Alavattam Sreedhara, Rita L. Wong, Yvonne Lentz, Karin Schoenhammer, Christoph Stark
    Pages 115-135
  8. Ambarish Shah, Feroz Jameel, Sajal M. Patel
    Pages 137-158
  9. Philippe Lam, Fredric J. Lim, Samir U. Sane
    Pages 159-189
  10. Feroz Jameel, Sonja Wolfrum
    Pages 211-236
  11. Feroz Jameel, Cenk Undey, Paul M. Kovach, Jart Tanglertpaibul
    Pages 265-302
  12. Sajal M. Patel, Feroz Jameel, Samir U. Sane, Madhav Kamat
    Pages 303-329
  13. Fran DeGrazio, Lionel Vedrine
    Pages 365-401
  14. Rey T. Chern, Jeffrey C. Givand, Robin Hwang, Thomas J. Nikolai
    Pages 403-435
  15. Liuquan (Lucy) Chang, Jeffrey T. Blue, Joseph Schaller, Lynn Phelan, Lakshmi Khandke, Bruce A. Green
    Pages 437-473
  16. Vladimir Razinkov, Jerry Becker, Cenk Undey, Erwin Freund, Feroz Jameel
    Pages 475-510
  17. Timothy Schofield, David Robbins, Guillermo Miró-Quesada
    Pages 511-535
  18. Davide Fissore, Roberto Pisano, Antonello A. Barresi
    Pages 565-593
  19. Feroz Jameel, William J. Kessler, Stefan Schneid
    Pages 605-647
  20. Fredric J. Lim, Jagannathan Sundaram, Alavattam Sreedhara
    Pages 661-692
  21. Back Matter
    Pages 707-710

About this book


This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling.


Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.


Design Drug Jameel Product Quality

Editors and affiliations

  • Feroz Jameel
    • 1
  • Susan Hershenson
    • 2
  • Mansoor A. Khan
    • 3
  • Sheryl Martin-Moe
    • 4
  1. 1.Parenteral Product and Process DevelopmentAmgen Inc.Thousand OaksUSA
  2. 2.Bill and Melinda Gates Foundation, Chemistry, Manufacturing and ControlsSeattleUSA
  3. 3.Division of Product Quality ResearchFood and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research and Office of Pharmaceutical SciencesSilver SpringUSA
  4. 4.Enterprise Catalyst Group Inc.Palo AltoUSA

Bibliographic information

  • DOI
  • Copyright Information Springer Science+Business Media, LLC 2015
  • Publisher Name Springer, New York, NY
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-1-4939-2315-1
  • Online ISBN 978-1-4939-2316-8
  • Series Print ISSN 2210-7371
  • Series Online ISSN 2210-738X
  • Buy this book on publisher's site