Date: 16-feb-2024
Attendees: Mark Ma; Tong-Yuan Yang; Dominic Warrino; Eric Wakskhull; Wang Jin, Elisa Cifuentes, Sophia Xu, Shoshana Oberstein, Sasha Fraser; Lakshmi Amaravad; Kelly Colletti; Malone, Katherine Sanjeev Bhardwaj;;Rachel Wang;
Topic: Journal club: An integrated multiplatform bioanalytical strategy for ADC -led by Sasha Fraser.
Presenter: Sasha Fraser.
During the meeting, Sasha Fraser presented the work based on the following paper: Myler (2015) An Integrated multiplatform bioanalytical strategy for ADC: a novel case study
Essentially, the following aspects are covered.
§ Evolved bioanalytical strategies are needed to separately identify, characterize and quantify ADC to provide information about exposure-response relationship
o DAR Definition; and its use to partially understand ADC heterogeneity
o DAR Determination; an integrated approach using conjugated payload (Hybrid LC-MS) and total antibody (LBA)
o Case Study - Highlighting validation data & application of DAR determination using multiplatform approach in IND Enabling TK Study
§ Scientific discussion: Reproducible correlation between LBA and LC-MS Total Ab concentrations could present a viable opportunity for a single core assay (LBA) for Total Ab; and potential for routine DAR determination using integrated multiplatform determination of DAR.