Chapter 6: Immunogenicity assessment for biosimilars: assay development, validation and interpretation

Doi: 10.4155/FSEB2013.14.303 Authors James Munday* Study Director Covance Camille Dycke Associate Director, Biological Assays, MMTech, Global Biologics QC Genentech *Corresponding Author e-mail: [email protected] About the Authors James Munday James Munday gained his D.Phil at the University of Oxford working in the field of cellular and molecular immunology. He then went onto to do his postdoctoral studies at the Mount Sinai School of Medicine in New York where he published his work on transcription factor regulation of hematopoiesis and vasculogenesis. Following on from his academic career he moved into industry posts at Celltech, UCB and Quotient Bioresearch. His current role is...