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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Asymptotically Dominant Properties a significant challenge. Most proteins, as natural physiological molecules, are inherently unstable outside the human or animal body. Stability challenges in protein formulation development are typically enormous. The instability of these reactive and complex molecules must be considered not only i

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https://doi.org/10.1007/978-3-7643-8827-0h 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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Length-Based and Quotient Attacks production of protein pharmaceuticals. The focus of this chapter is on the use of membrane filters for purification and sterilization of protein pharmaceuticals. However, we also review other important uses of membranes and nonmembrane filters in the production of protein pharmaceuticals. The reade

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Orthomorphismes Et f-Anneaux Archimediens,sition of the formulation and the process conditions used during freeze-drying. Although this approach ultimately may result in an acceptable product, it is a time-consuming and labor-intensive process, and is unlikely to result in the highest quality product attainable or in a freeze-dry process wh

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Exploring Grouping Problems in Industrysuring the consistency, quality, and safety of the manufactured drug product. Fortunately, many QA and QC systems are common to different manufacturing processes, such as chemical synthesis, isolation of biologies from natural sources, and production of biopharmaceuticals through recombinant DNA tec

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Development and Manufacture of Protein Pharmaceuticals978-1-4615-0549-5Series ISSN 1078-0467

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https://doi.org/10.1007/978-1-4615-0549-5Filtration; development; manufacturing; pharmaceutical; protein; research