Bioanalysis of ADCs is challenging and requires the quantitation of multiple analytes using LBA, LC–MS and hybrid LBA/LC–MS assays. This presentation provided technical guidance for scientists conducting hybrid assays for ADC bioanalysis. The presentation also discussed current hot topics in ADC bioanalysis, including: assay format; DAR sensitivity; PK modeling; as well as the correlation between hybrid assays and LBAs. Hybrid assays are complementary or viable alternatives to LBA for ADC bioanalysis and PK/PD modeling. The fit-for-purpose choice of analytes, assays and platforms and an integrated strategy from discovery to development for ADC PK and bioanalysis are recommended.
What will you learn?
- Technical guidance for hybrid ligand binding and LC–MS assays in ADC bioanalysis
- Correlation between hybrid assays and LBAs from case studies
- Fit-for-purpose discovery and development integrated ADC bioanalytical strategy
Who may this interest?
- CROs, Pharma and Biotech companies using both LBA and LC–MS for quantitative bioanalysis in developing ADCs and other large molecule drugs
- Bioanalytical scientists with LC–MS or LBA training as well as health authority representatives
- Academicians and students interested in ADCs and other large molecules bioanalysis
Dr Wang received his PhD in analytical chemistry at Michigan State University in 1994. Following postdoctoral training at the National Institutes of Health, he joined GSK in 1996 and then Bristol-Myers Squibb in 1997. Dr Wang has 20 years of experience in bioanalysis in pharmaceutical industry. In recent years, Dr Wang has been leading a group of scientists in developing hybrid ligand binding and LC–MS assays for ADC bioanalysis in an LBA and LC–MS integrated approach. Currently, Dr Wang serves as the coordinator of Regulated Bioanalysis Interest Group at ASMS and a sub-team lead of AAPS ADC bioanalysis committee.