Download PDF Development and Manufacture of Protein Pharmaceuticals (Pharmaceutical Biotechnology)From Springer
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Development and Manufacture of Protein Pharmaceuticals (Pharmaceutical Biotechnology)From Springer
Download PDF Development and Manufacture of Protein Pharmaceuticals (Pharmaceutical Biotechnology)From Springer
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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.
- Sales Rank: #3147702 in Books
- Published on: 2002-06-30
- Original language: English
- Number of items: 1
- Dimensions: 9.02" h x 1.25" w x 5.98" l, 1.87 pounds
- Binding: Hardcover
- 464 pages
Most helpful customer reviews
2 of 2 people found the following review helpful.
diverse topics
By W Boudville
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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