Development and Manufacture of Protein Pharmaceuticals (Pharmaceutical Biotechnology) (Pharmaceutical Biotechnology (closed))

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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.

Development and Manufacture of Protein Pharmaceuticals (Pharmaceutical Biotechnology) (Pharmaceutical Biotechnology (closed)) Review

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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