Development of Biopharmaceutical Drug-Device Products

  • Feroz Jameel
  • John W. Skoug
  • Robert R. Nesbitt

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)

Table of contents

  1. Front Matter
    Pages i-xviii
  2. Drug Product Development

    1. Front Matter
      Pages 1-1
    2. Feroz Jameel, Brittney J. Mills, Ehab M. Moussa, Vikram Sisodiya, Tony Cano, Anthony R. Haight
      Pages 27-48
    3. Peter M. Ihnat, Jun Zhang, Jianwen Xu, Kan Wu, Ralf Joe Carrillo
      Pages 117-138
    4. Yangjie Wei, Sangeeta B. Joshi, Akhilesh Bhambhani, Yuhong Zeng, Nicholas R. Larson, Gang Hu et al.
      Pages 139-185
    5. Yangjie Wei, Nicholas R. Larson, Gang Hu, Prashant Kumar, C. Russell Middaugh
      Pages 187-213
    6. Lisa Connell-Crowley, Bruce Kerwin, Randal Ketchem, Jeff McGrew, Richard S. Rogers
      Pages 215-231
    7. Stephanie Fischmann, Julie L. Heflin, Joseph Eschweiler, Beijing Huang, Maike Eisenkolb, Stephanie Katzenbach et al.
      Pages 233-250
    8. Steven Messick, Miguel Saggu, Anacelia Ríos Quiroz
      Pages 251-264
    9. Feroz Jameel, Ehab M. Moussa, Brittney J. Mills, Peter M. Ihnat
      Pages 265-297
    10. Michael Siedler, Sabine Eichling, Martin Huelsmeyer, Jonas Angstenberger
      Pages 299-341
    11. Qingyan Hu, Bowen Jiang, Dingjiang (Dean) Liu, Xiaolin (Charlie) Tang, Thomas Daly, Mohammed Shameem
      Pages 343-372
    12. Supriya Gupta, Amr Alaarg, Zhen Wu, Xiaofeng Lu, VivekKumar Garripelli, Hanmin Dong et al.
      Pages 431-459
    13. Feroz Jameel, Tong Zhu, Brittney J. Mills
      Pages 461-486
    14. Alina A. Alexeenko, Laura Mozdzen, Sherwin Shang, Michelle A. Long, Grace Kim, Margaret Musser
      Pages 487-498
    15. Feroz Jameel, Tong Zhu, Ehab M. Moussa, Brittney J. Mills
      Pages 499-537
    16. Feroz Jameel, Ann M. Czyzewski, Tong Zhu, Kushal Sinha, Nandkishor K. Nere
      Pages 539-565
  3. Drug-Device Combination Products

    1. Front Matter
      Pages 639-639
    2. Harold K. Yeager, Mary Roesner Brokovich, Michael J. Roe, Paul E. Jansen
      Pages 641-655
    3. Suzette M. Roan, Bonnie Scott, James Boiani
      Pages 657-693
    4. Harold K. Yeager, Mary Roesner Brokovich, Beat U. Steffen, Michael J. Roe
      Pages 713-727
    5. Robert R. Nesbitt, Harold K. Yeager, Michael J. Roe, Niels Hansen
      Pages 729-739
    6. David A. Post, Sherwin Shang, Shweta A. Raina, William Szechinski
      Pages 831-854
  4. Back Matter
    Pages 867-893

About this book


The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies.
With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products.  It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them.  It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).
Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device.  Finally, case studies are provided throughout.
The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field. 


engineered anitbodies drug discovery combination drug-device products New modalities, mAbs, ADC, Bites, CAR-T, DVD, Dualbodies, mRNA Molecular assessment and preformulation Monoclonal antibodies Multi-attribute Method (MAM) Biotherapeutics Therapeutic Antibody Discovery Bispecfic Antibodies Combination Drug product Protein Therapeutics Screening Excipients

Editors and affiliations

  • Feroz Jameel
    • 1
  • John W. Skoug
    • 2
  • Robert R. Nesbitt
    • 3
  1. 1.Formulation Development New Biological EntitiesAbbVie (United States)North ChicagoUSA
  2. 2.Drug Product Development (Retired)AbbVie (United States)North ChicagoUSA
  3. 3.Combination Product DevelopmentAbbVie, Inc.North ChicagoUSA

Bibliographic information

  • DOI
  • Copyright Information American Association of Pharmaceutical Scientists 2020
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-3-030-31414-9
  • Online ISBN 978-3-030-31415-6
  • Series Print ISSN 2210-7371
  • Series Online ISSN 2210-738X
  • Buy this book on publisher's site