Development and Manufacture of Protein Pharmaceuticals

1. Front Matter

   Pages i-xx

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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

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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.

• Filtration
• development
• manufacturing
• pharmaceutical
• protein
• research

• Purdue University, West Lafayette, USA

  Steve L. Nail

• Baxter Pharmaceutical Solutions LLC, Bloomington, USA

  Michael J. Akers

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