Biosimilars of Monoclonal Antibodies : A Practical Guide to Manufacturing, Preclinical, and Clinical Development

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