Biosimilars of Monoclonal Antibodies: A Practical Guide to by Cheng Liu, K. John Morrow Jr.

By Cheng Liu, K. John Morrow Jr.

Addressing an important want through describing the technological know-how and strategy concerned to advance biosimilars of monoclonal antibody (mAb) medicinal drugs, this e-book covers all facets of biosimilar improvement: preclinical, medical, regulatory, manufacturing.

• Guides readers in the course of the complicated panorama concerned with constructing biosimilar models of monoclonal antibody (mAb) drugs
• Features move charts, tables, and figures that truly illustrate strategies and makes the booklet understandable and accessible
• Includes a evaluation of FDA-approved mAb medicinal drugs as a short connection with evidence and worthy information
• Examines new applied sciences and methods for bettering biosimilar mAbs

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

Sample text

From Columbia Law School. K. John Morrow, Jr. A molecular biologist, K. John Morrow, Jr. is president of Newport Biotechnology Consultants. He specializes in writing and consulting in the area of immunology, with a focus on antibody technology. D. from the University of Washington and did postdoctoral studies in Italy at the Università degli Studi di Pavia and at the Fox Chase Cancer Center in Philadelphia. He has been employed at several universities as a faculty member including Texas Tech and Kansas University and has also worked in the private sector.

In Chapter 16, Rafiq Islam reviews the development of bioanalytical tests of biosimilar antibodies, including glycosylation pattern, ADCC/CDC activity, and FcγR binding profile. Critical features of such characterizations are the test results required to demonstrate similarity to the original product, as stated in the regulatory guidelines issued by the FDA and EMEA. Drs. João Fonseca and João Gonçalves cover preclinical and clinical development of biosimilar antibodies in Chapter 17. They touch on a recurrent theme in this book: that biosimilars offer a highly attractive strategy for reducing medical costs and increasing accessibility to targeted biologic therapies.

Projan joined Wyeth in 1993 as a group leader in anti‐infectives research. He became an associate director of Bacterial Genetics in January of 1997 and then director of Antibacterial Research in June of 1998. In May of 2003 he was appointed assistant vice president of Protein Technologies, and in September 2004 he was promoted to vice president and head of the newly created Department of Biological Technologies which was responsible for delivery of novel biologics to development (this group is now part of Pfizer).

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