Ebook: Development and Manufacture of Protein Pharmaceuticals

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.

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This text focuses on development, manufacture, and commercialization of pharmaceutical protein dosage forms. The text envelops and emphasizes GMP attributes of quality, safety, purity, and strength. Each author provides practical, proven approaches and methods to achieve quality protein dosage forms on a commercial scale. No other book on protein goes into such practical detail on the requirements, and how to meet them, for developing, manufacturing, and gaining regulatory approval of protein dosage forms.

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This text focuses on development, manufacture, and commercialization of pharmaceutical protein dosage forms. The text envelops and emphasizes GMP attributes of quality, safety, purity, and strength. Each author provides practical, proven approaches and methods to achieve quality protein dosage forms on a commercial scale. No other book on protein goes into such practical detail on the requirements, and how to meet them, for developing, manufacturing, and gaining regulatory approval of protein dosage forms.
Content:
Front Matter....Pages i-xx
Preformulation Studies as an Essential Guide to Formulation Development and Manufacture of Protein Pharmaceuticals....Pages 1-46
Formulation Development of Protein Dosage Forms....Pages 47-127
Aseptic Processing of Protein Pharmaceuticals....Pages 129-189
Fundamentals of Thermal Sterilization Processes....Pages 191-212
Membrane Filtration....Pages 213-279
Fundamentals of Freeze-Drying....Pages 281-360
Quality Assurance and Quality Control for Biopharmaceutical Products....Pages 361-404
Regulatory Considerations in the Development of Protein Pharmaceuticals....Pages 405-456
Back Matter....Pages 457-462

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This text focuses on development, manufacture, and commercialization of pharmaceutical protein dosage forms. The text envelops and emphasizes GMP attributes of quality, safety, purity, and strength. Each author provides practical, proven approaches and methods to achieve quality protein dosage forms on a commercial scale. No other book on protein goes into such practical detail on the requirements, and how to meet them, for developing, manufacturing, and gaining regulatory approval of protein dosage forms.
Content:
Front Matter....Pages i-xx
Preformulation Studies as an Essential Guide to Formulation Development and Manufacture of Protein Pharmaceuticals....Pages 1-46
Formulation Development of Protein Dosage Forms....Pages 47-127
Aseptic Processing of Protein Pharmaceuticals....Pages 129-189
Fundamentals of Thermal Sterilization Processes....Pages 191-212
Membrane Filtration....Pages 213-279
Fundamentals of Freeze-Drying....Pages 281-360
Quality Assurance and Quality Control for Biopharmaceutical Products....Pages 361-404
Regulatory Considerations in the Development of Protein Pharmaceuticals....Pages 405-456
Back Matter....Pages 457-462
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