Skip to main content
SpringerLink
Log in
Book cover

Development and Manufacture of Protein Pharmaceuticals

  • Book
  • © 2002

Overview

Editors:
  1. Steve L. Nail

    1. Purdue University, West Lafayette, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  2. Michael J. Akers

    1. Baxter Pharmaceutical Solutions LLC, Bloomington, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

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

This is a preview of subscription content, log in via an institution to check access.

Access this book

Log in via an institution
eBook USD 169.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book USD 219.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book USD 219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access

Licence this eBook for your library

Institutional subscriptions

Table of contents (8 chapters)

  1. Front Matter

    Pages i-xx
    Download chapter PDF

  2. Preformulation Studies as an Essential Guide to Formulation Development and Manufacture of Protein Pharmaceuticals

    • David B. Volkin, Gautam Sanyal, Carl J. Burke, C. Russell Middaugh
    Pages 1-46

  3. Formulation Development of Protein Dosage Forms

    • Michael J. Akers, Vasu Vasudevan, Mary Stickelmeyer
    Pages 47-127

  4. Aseptic Processing of Protein Pharmaceuticals

    • Michael Townsend
    Pages 129-189

  5. Fundamentals of Thermal Sterilization Processes

    • Richard T. Wood
    Pages 191-212

  6. Membrane Filtration

    • Daniel J. Brose, Michael Dosmar, Maik W. Jornitz
    Pages 213-279

  7. Fundamentals of Freeze-Drying

    • Steven L. Nail, Shan Jiang, Suchart Chongprasert, Shawn A. Knopp
    Pages 281-360

  8. Quality Assurance and Quality Control for Biopharmaceutical Products

    • John Geigert
    Pages 361-404

  9. Regulatory Considerations in the Development of Protein Pharmaceuticals

    • Michael G. Beatrice
    Pages 405-456

  10. Back Matter

    Pages 457-462
    Download chapter PDF
Back to top

Keywords

About this book

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.

Editors and Affiliations

  • Purdue University, West Lafayette, USA

    Steve L. Nail

  • Baxter Pharmaceutical Solutions LLC, Bloomington, USA

    Michael J. Akers

Bibliographic Information

Publish with us

Policies and ethics

Back to top

Search

Navigation