Development and Manufacture of Protein Pharmaceuticals: 14 (Pharmaceutical Biotechnology) - Hardcover

 
9780306467455: Development and Manufacture of Protein Pharmaceuticals: 14 (Pharmaceutical Biotechnology)
Hardcover
ISBN 10: 0306467453 ISBN 13: 9780306467455
Verlag: Springer, 2002

Inhaltsangabe

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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Reseña del editor

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.

Reseña del editor

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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Verlag
Springer
Erscheinungsdatum
2002
Sprache
Englisch
ISBN 10 
0306467453
ISBN 13 
9780306467455
Einband
Tapa dura
Anzahl der Seiten
492
Herausgeber
Akers Michael J., Nail Steve L.
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
CMN Printpool Inh. Mathis Neumann
https://www.also.com/ec/cms5/en_6000/6000/index.jsp

Friedrich-Karl-Str. 9
Hamburg
Deutschland

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9781461351276: Development and Manufacture of Protein Pharmaceuticals: 14 (Pharmaceutical Biotechnology)

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ISBN 10:  1461351278 ISBN 13:  9781461351276
Verlag: Springer, 2012
Softcover