Luke Bi

Executive Director, Head of China BioA and APAC LCMS
Labcorp
 

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PhD, pharmaceutical science, University of Southern California
 
Joined Labcorp Bioanalytical Services in 2009 and has more than 30 years of pharmaceutical and lab management experience.
 
Previously served as a clinical pharmacology reviewer at the FDA and CDER and has extensive experience as a research scientist for prominent pharmaceutical companies.

Speech title & Synopsis

Regulatory and Scientific Considerations for ADC Bioanalysis

Antibody-drug conjugates (ADCs) are complex therapeutic modalities that require tailored bioanalytical strategies to ensure accurate pharmacokinetic and immunogenicity assessments. The current emergence of ADC with high drug to antibody ratio (DAR) is posing a challenge in the ADC PK assay development, as the ADC PK assay may not be optimized to determine the ADC PK without significant bias as the average DAR value changed due to biotransformation.
 
This presentation shares Labcorp Shanghai experience in ADC bioanalysis and focus on regulatory and scientific considerations.  The presentation will focus on ADC PK method development and evaluation to ensure the ADC PK assay is insensitive to drug-to-antibody ratio (DAR).  While both ligand binding assay (LBA) and hybrid LC/MS assay would work for the analysis of ADC PK in biological specimen; bioanalytical lab will use different DAR reference material to ensure the ADC PK assay does not generate significant bias against various DAR.  A DAR insensitive ADC assay will be critical in characterize the ADC PK, in evaluation of the linker stability and exposure response relationship.   The ADC DAR sensitivity issue could be identified with careful assessment of the total antibody and ADC PK relationship from the early clinical analysis and then be addressed accordingly.  The FDA guidance on ADC also requires determination of soluble target and total biomarker.  An experience bioanalytical lab would provide multiple solutions to characterize the ADC PK and its exposure response relationship and facilitate the clinical drug development.