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Development and Manufacture of Protein Pharmaceuticals (Pharmaceutical Biotechnology) |  | Author: Steve L. Nail
Creator: Steve L. Nail; Michael J. Akers
Publisher: Springer
Category: Book
List Price: $399.00
Buy New: $271.30
as of 7/31/2010 03:00 CDT details
You Save: $127.70 (32%)
New (9) Used (7) from $235.70
Seller: oddesseyy
Rating:  1 reviews
Media: Hardcover
Edition: 1
Pages: 476
Number Of Items: 1
Shipping Weight (lbs): 1.9
Dimensions (in): 9.1 x 6.4 x 1.6
ISBN: 0306467453
Dewey Decimal Number: 615.19
EAN: 9780306467455
Availability: Usually ships in 1-2 business days
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Product Description
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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| Customer Reviews:
diverse topics January 11, 2008
W Boudville (Terra, Sol 3)
2 out of 2 found this review helpful
The book is a collection of research chapters on various aspects of protein pharmaceuticals, contributed by authors who are at firms in this industry. The topics are broad.
One topic is how to thermally sterilise the manufacturing. There's some elementary thermodynamics and kinetics covered here, that centres on killing off microbes. A key idea is that sterility is not an absolute, binary concept, but is modelled by a probability distribution. A pragmatic recognition that absolute assurance is often unnecessary and too expensive.
Typically, the chapters contain a mixture of basic chemistry and biology, along with engineering issues and diagrams that are needed in a production environment.
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