Integrated Bioanalytical Platform Accelerates ADC IND Filing

FDA has approved a dozen of antibody-drug conjugates (ADCs) to date, and 6 of them were approved since 2019, making it one of the fastest-growing classes of new drugs. 

The complex nature of ADC requires comprehensive bioanalytical strategies. ADCs are heterogeneous mixtures of multiple species that can exist in various forms in vivo: free payload, unconjugated antibody, varying levels of conjugation, payload related species, etc. Each of these forms can have its distinct impact on the drug's safety, or pharmacokinetics. 

WuXi AppTec DMPK has well-established LC-MS and LBA platforms for the bioanalysis of in vitro and in vivo structural variation of ADCs, to facilitate understanding of ADCs, and accelerate the drug development process.