| 书目名称 | Challenges in Protein Product Development |
| 编辑 | Nicholas W. Warne,Hanns-Christian Mahler |
| 视频video | |
| 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 |
| 丛书名称 | AAPS Advances in the Pharmaceutical Sciences Series |
| 图书封面 |  |
| 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 |
| 关键词 | ADCs; Mabs; biologics; formulation; lyophilization; therapeutic proteins; HC Protein formulations; containe |
| 版次 | 1 |
| doi | https://doi.org/10.1007/978-3-319-90603-4 |
| isbn_softcover | 978-3-030-08052-5 |
| isbn_ebook | 978-3-319-90603-4Series ISSN 2210-7371 Series E-ISSN 2210-738X |
| issn_series | 2210-7371 |
| copyright | American Association of Pharmaceutical Scientists 2018 |
发表于 2025-3-21 20:03:20
