Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information Examines new technologies and strategies for improving biosimilar mAbs
Publisher: John Wiley & Sons Inc ISBN: 9781118662311 Number of pages: 704 Weight: 1146 g Dimensions: 242 x 166 x 37 mm
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