Monoclonal antibody therapeutics : structure, function, and regulatory space
著者
書誌事項
Monoclonal antibody therapeutics : structure, function, and regulatory space
（ACS symposium series, 1176 . State-of-the-art and emerging technologies for therapeutic monoclonal antibody characterization ; 1）
American Chemical Society , Distributed in print by Oxford University Press, c2014
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注記
Includes bibliographical references and index
収録内容
- volume 1. Monoclonal antibody therapeutics : structure, function, and regulatory space
内容説明・目次
内容説明
Monoclonal antibodies (mAbs) are an important class of therapeutic that has greatly expanded our ability to treat a variety of indications, including cancer, autoimmune disorders, and infectious diseases. The cost of developing these molecules and ensuring that they are fit for purpose is much higher than for small-molecule drugs. Although some of these costs are due in part to the nature of production, a major cost is incurred because of the complexity of the
molecule itself. Extensive analytical testing regimes are needed for in-depth characterization and to ensure product stability, proper in-process controls, safety, and efficacy. The next generation of product understanding will require highly complex, orthogonal technologies to elucidate interdependent
structure-function relationships.
The ACS' focus on this field of research represents a defining moment in the development of technologies for characterizing mAbs. A multitude of experts in the field have come together around a single molecule for the first time to demonstrate both current and future practices involved in the characterization of a biotherapeutic. The current series presents an open discussion of current best practices, a multitude of intuitive research, and a collaborative philosophy on where the field needs to
move to satisfy future scientific and regulatory needs. Throughout this effort, a first-of-a-kind repository of regulatory considerations, experimental methods, and data-as well as a widely available "reference"-are now available to industry, academia, regulatory personnel, and instrument
manufacturers.
目次
1. Monoclonal Antibody Therapeutics: The Need for Biopharmaceutical Reference Materials
2. Monoclonal Antibodies: Mechanisms of Action
3. Heterogeneity of IgGs: Role of Production, Processing, and Storage on Structure and Function
4. Perspectives on Well-Characterized Biological Proteins
5. Using Quality by Design Principles in Setting a Control Strategy for Product Quality Attributes
Appendix
Editors' Biographies
Indexes
Author Index
Subject Index
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