Abstract

Best Practices in Developing Bioanalytical Assays for Assessment of Antibody-Drug Conjugates

Arumugam Muruganandam, Managing Director & Chief Scientific Officer, Affigenix Biosolutions Pvt Ltd

The presentation will cover approaches needed for successful development of bioanalytical assays for antibody-drug conjugates. ADCs are new class of Bio-Pharma drugs comprising a therapeutic monoclonal antibody and a cytotoxic drug connected by a linker. The nature of the drug make it more complex and there are unique challenges to overcome in developing customized critical reagents for assessing PKPD and immunogenicity and NAbs. Some of the recent recommendations and point to consider in developing ADC will be discussed.