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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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Formulation Development of Protein Dosage Forms,enges in protein formulation development are typically enormous. The instability of these reactive and complex molecules must be considered not only in the . process, but also in development of the . and the . process. These three areas are intimately and inseparably connected.
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Fundamentals of Thermal Sterilization Processes,versible. However, as currently defined in the pharmaceutical industry, the effectiveness of a sterilization process is determined by the statistical probability of a non-sterile unit (PNSU) in a lot or batch of product.
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https://doi.org/10.1007/978-3-319-44394-2cation of biological systems to technical and industrial processes” (Bonk, 1987). However, as applied to production of pharmaceutical products, it was a new technology for products intended to diagnose and treat diseases or conditions in humans.
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Book 2002ny 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 mo
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Fundamentals of Freeze-Drying,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 which is optimized.
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