Bioanalytical Community

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 coveredd.

§  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.

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Xiaohui Xu Ph.D.
Director
Daiichi Sankyo
Basking Ridge NJ
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Attachment(s)

validated_DAR_quantification in PK samples by IP_LC-MS201...pdf   731 KB 1 version

PK assay group meeting minutes_Feb2024.docx   20 KB 1 version

ADC bioanalytical strategy case study_BMS_Bioanalysis2015...pdf   1.29 MB 1 version