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Development and Manufacture of Protein Pharmaceuticals

  • Steve L. Nail
  • Michael J. Akers

Part of the Pharmaceutical Biotechnology book series (PBIO, volume 14)

Table of contents

  1. Front Matter
    Pages i-xx
  2. David B. Volkin, Gautam Sanyal, Carl J. Burke, C. Russell Middaugh
    Pages 1-46
  3. Michael J. Akers, Vasu Vasudevan, Mary Stickelmeyer
    Pages 47-127
  4. Michael Townsend
    Pages 129-189
  5. Richard T. Wood
    Pages 191-212
  6. Daniel J. Brose, Michael Dosmar, Maik W. Jornitz
    Pages 213-279
  7. Steven L. Nail, Shan Jiang, Suchart Chongprasert, Shawn A. Knopp
    Pages 281-360
  8. Back Matter
    Pages 457-462

About this book

Introduction

In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop­ ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.

Keywords

Filtration development manufacturing pharmaceutical protein research

Editors and affiliations

  • Steve L. Nail
    • 1
  • Michael J. Akers
    • 2
  1. 1.Purdue UniversityWest LafayetteUSA
  2. 2.Baxter Pharmaceutical Solutions LLCBloomingtonUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-1-4615-0549-5
  • Copyright Information Kluwer Academic/Plenum Publishers 2002
  • Publisher Name Springer, Boston, MA
  • eBook Packages Springer Book Archive
  • Print ISBN 978-1-4613-5127-6
  • Online ISBN 978-1-4615-0549-5
  • Series Print ISSN 1078-0467
  • Buy this book on publisher's site