Challenges in Protein Product Development

  • Nicholas W. Warne
  • Hanns-Christian Mahler

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 38)

Table of contents

  1. Front Matter
    Pages i-xvi
  2. Formulation Development of Biologics

    1. Front Matter
      Pages 1-1
    2. Daniel Weinbuch, Andrea Hawe, Wim Jiskoot, Wolfgang Friess
      Pages 3-22
  3. Challenges with Excipients

    1. Front Matter
      Pages 23-23
    2. Kishore S. K. Ravuri
      Pages 25-62
  4. High Concentration Proteins

    1. Front Matter
      Pages 97-97
    2. Wei Wang, Arun Alphonse Ignatius, Satoshi Ohtake, Teng-Chieh Yang
      Pages 99-123
    3. Hanns-Christian Mahler, Anja Matter
      Pages 125-137
    4. Andrea Allmendinger, Stefan Fischer, Robert Mueller
      Pages 139-161
    5. Deirdre Murphy Piedmonte, Jian Hua Gu, Stephen R. Brych, Monica M. Goss
      Pages 163-187
  5. Container-Closure Systems

    1. Front Matter
      Pages 189-189
    2. Roman Mathaes, Alexander Streubel
      Pages 191-202
    3. Mariana N. Dimitrova, Jared S. Bee, Ling Lu, Jason E. Fernandez
      Pages 203-224
    4. Dirk Gläser, Jürg Liniger, Daniel Peter
      Pages 235-256
    5. Holger Roehl, Philippe Lam, Dominique Ditter
      Pages 291-304
    6. Holger Roehl, Philippe Lam, Dominique Ditter
      Pages 305-309
  6. Processing Considerations

    1. Front Matter
      Pages 311-311
    2. Daniel Dixon, Anthony Gudinas
      Pages 353-383
    3. Ulla Grauschopf, Katherine Thomas, Joerg Luemkemann, Sebastian Schneider, Ada Hui, Y. John Wang et al.
      Pages 385-406
    4. Daniel Dixon, Serguei Tchessalov, Bakul Bhatnagar
      Pages 407-439
  7. Novel Constructs

    1. Front Matter
      Pages 495-495
    2. Susanne Joerg, Kapil Gupta, Margarida Rodrigues
      Pages 497-526
    3. Jeonghoon Sun, Mark Michaels
      Pages 527-544
    4. Carole Heath, Dean Pettit
      Pages 545-558
  8. Lifecycle Management

    1. Front Matter
      Pages 559-559
    2. Nicholas Warne, Bryan Balthazor, William Parr
      Pages 561-578
  9. Back Matter
    Pages 591-599

About this book


In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.


ADCs Mabs biologics formulation lyophilization therapeutic proteins HC Protein formulations container closure formulations parenteral products bulk protein solution lyophilization fusion proteins biotherapeutic dosage forms novel constructs

Editors and affiliations

  • Nicholas W. Warne
    • 1
  • Hanns-Christian Mahler
    • 2
  1. 1.BioTherapeutics Research and Development Pharmaceutics Research and DevelopmentPfizer Inc.AndoverUSA
  2. 2.Lonza AGDrug Product ServicesBaselSwitzerland

Bibliographic information

  • DOI
  • Copyright Information American Association of Pharmaceutical Scientists 2018
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-3-319-90601-0
  • Online ISBN 978-3-319-90603-4
  • Series Print ISSN 2210-7371
  • Series Online ISSN 2210-738X
  • Buy this book on publisher's site