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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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

collateral

向外

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

向外

Aesthete

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

entreat

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