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

小溪

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

optic-nerve

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

小争吵

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

侵蚀

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

Aromatic

来自于

认为

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

Minutes

locus-ceruleus

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

Amylase

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