| State-Of-The-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 1.: Monoclonal Antibody Therapeutics: Structure Contributor(s): Schiel, John E. (Editor), Davis, Darryl L. (Editor), Borisov, Oleg V. (Editor) |
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ISBN: 0841230269 ISBN-13: 9780841230262 Publisher: American Chemical Society OUR PRICE: $231.00 Product Type: Hardcover - Other Formats Published: April 2016 * Not available - Not in print at this time * |
| Additional Information |
| BISAC Categories: - Medical | Immunology - Science | Life Sciences - Biochemistry - Science | Chemistry - Organic |
| Dewey: 616.079 |
| LCCN: 2014040141 |
| Physical Information: 0.6" H x 6" W x 9.1" (0.85 lbs) 184 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: 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. |
