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

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發(fā)表于 2025-3-21 20:03:20 | 只看該作者 |倒序瀏覽 |閱讀模式
書目名稱Challenges in Protein Product Development
編輯Nicholas W. Warne,Hanns-Christian Mahler
視頻videohttp://file.papertrans.cn/224/223486/223486.mp4
概述Discusses 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
叢書名稱AAPS Advances in the Pharmaceutical Sciences Series
圖書封面Titlebook: Challenges in Protein Product Development; Nicholas W. Warne,Hanns-Christian Mahler Book 2018 American Association of Pharmaceutical Scien
描述In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration,solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal o
出版日期Book 2018
關(guān)鍵詞ADCs; Mabs; biologics; formulation; lyophilization; therapeutic proteins; HC Protein formulations; containe
版次1
doihttps://doi.org/10.1007/978-3-319-90603-4
isbn_softcover978-3-030-08052-5
isbn_ebook978-3-319-90603-4Series ISSN 2210-7371 Series E-ISSN 2210-738X
issn_series 2210-7371
copyrightAmerican Association of Pharmaceutical Scientists 2018
The information of publication is updating

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The third stage and fetal adaptationts can relate to concentration, type of formulation, but also process- or product-related degradants or contaminants. Solution viscosity is of utmost importance for manufacturing as well as administration of biologics at higher concentration. Finally, aggregates and particles can arise as a result o
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Aspects of monitoring in normal labourracterization are discussed in detail and practical recommendation is given. Different common techniques to measure viscosity are described including dependencies on protein concentration, temperature, and shear stress. Structural characterization of highly concentrated protein formulations requires
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Charles Yuen Yung Loh,N. S. Niranjan are microbial challenge test, liquid tracer leak test, vacuum decay leak test, electrical conductivity leak test, tracer gas leak test, and headspace gas analyzer. Finally, the development, qualification, and validation of a method to be used are discussed. Each CCI test method has its advantages a
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Ahmed A. Kamel,John V. Breakwellare discussed in detail as well as analytical techniques suited to investigate the impact on the properties of the primary packaging containers. The combination of the knowledge about the underlying root cause and the respective analytical tools to characterize the vial internal surfaces will help b
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Solubility, Opalescence, and Particulate Matterts can relate to concentration, type of formulation, but also process- or product-related degradants or contaminants. Solution viscosity is of utmost importance for manufacturing as well as administration of biologics at higher concentration. Finally, aggregates and particles can arise as a result o
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