Titlebook: Challenges in Protein Product Development; Nicholas W. Warne,Hanns-Christian Mahler Book 2018 American Association of Pharmaceutical Scien

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Challenges in Protein Product Development978-3-319-90603-4Series ISSN 2210-7371 Series E-ISSN 2210-738X

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Nicholas W. Warne,Hanns-Christian MahlerDiscusses the challenges faced in biotechnology dosage form development.Provides practical and applied guidance in many areas including stability, microbiology and manufacturing, as well as case studi

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AAPS Advances in the Pharmaceutical Sciences Serieshttp://image.papertrans.cn/c/image/223486.jpg

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https://doi.org/10.1007/978-3-319-90603-4ADCs; Mabs; biologics; formulation; lyophilization; therapeutic proteins; HC Protein formulations; containe

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Polysorbate Degradation and Qualityins against interfacial stress. Structural heterogeneity, presence of degradants and other impurities, and tendency for degradation are interrelated features found in commercial PSs with a direct impact on their functional properties in biopharmaceutical products. These pose a challenge for the anal

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Introduction to High-Concentration Proteinsdose required for efficacy and patient-preferred self-administration through subcutaneous injection, which is oftentimes limited by dosing volume. Development of high-concentration protein products, however, has been associated with two major challenges—high solution viscosity and enhanced aggregati

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Solubility, Opalescence, and Particulate Matterng dosage form (liquid, dried), color (coloration of solution, color of cake), cake appearance (in case of a lyophilisate), opalescence, or turbidity, and—in some cases—even visible particles. “Maximum solubility” is a parameter that has been previously evaluated for proteins. But given the nature o