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Titlebook: Development and Manufacture of Protein Pharmaceuticals; Steve L. Nail,Michael J. Akers Book 2002 Springer Science+Business Media New York

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发表于 2025-3-21 18:01:21 | 显示全部楼层 |阅读模式
书目名称Development and Manufacture of Protein Pharmaceuticals
编辑Steve L. Nail,Michael J. Akers
视频video
丛书名称Pharmaceutical Biotechnology
图书封面Titlebook: Development and Manufacture of Protein Pharmaceuticals;  Steve L. Nail,Michael J. Akers Book 2002 Springer Science+Business Media New York
描述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,
出版日期Book 2002
关键词Filtration; development; manufacturing; pharmaceutical; protein; research
版次1
doihttps://doi.org/10.1007/978-1-4615-0549-5
isbn_softcover978-1-4613-5127-6
isbn_ebook978-1-4615-0549-5Series ISSN 1078-0467
issn_series 1078-0467
copyrightSpringer Science+Business Media New York 2002
The information of publication is updating

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发表于 2025-3-21 20:47:02 | 显示全部楼层
1078-0467 aging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength,978-1-4613-5127-6978-1-4615-0549-5Series ISSN 1078-0467
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Development and Manufacture of Protein Pharmaceuticals
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https://doi.org/10.1007/978-3-642-61275-6ture does not yet permit the more straightforward type of analysis utilized for small molecules to be simply applied. Nevertheless, it is still possible to treat proteins primarily as chemical (rather than biological) entities through an understanding of their structure and stability and use of a mo
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Preformulation Studies as an Essential Guide to Formulation Development and Manufacture of Protein aceutically acceptable drug substance. In the case of conventional, small-molecule (nonmacromolecular) pharmaceuticals, this procedure can usually be accomplished to a high degree of scientific rigor. For example, the atomic level structures of these compounds are usually known from a combination of
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Aseptic Processing of Protein Pharmaceuticals,h clinical supplies and the commercial market, from the perspective of the unique characteristics of protein-containing drug products. The discussion will be restricted to solution, suspension, and lyophilized dosage forms in final containers made of glass or plastic. It will present a conceptual fr
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