Confirming Gene Modifications on Release Using Flow Cytometry Assays

• Measuring knock out knock in or knockdown expression as a functional way of confirming whether the gene modification occurred.

• Using PCR-based methods to assess genomic knock out or knock-in efficiency as an orthogonal measure on characterization.

• Reducing measurement of redundant attributes on release to prevent assay deviations in QC

Presented by Akshata Ijantkar, Sr Principal Scientist at Bristol Myers Squibb.

Akshata Ijantkar is a Sr Principal Scientist at Bristol Myers Squibb, Seattle. She is the Analytical CMC lead for Autologous and Allogenic gene-edited programs. Her areas of expertise include statistics, assay design, analytical strategy, cell, and gene therapy. She was part of the product development team that led Breyanzi from process lock, IND, INDa, BLA, and post BLA/ commercial activities. Akshata has ten years of experience in cell therapy and twelve years of experience in analytical development. Before joining Juno Therapeutics (later acquired by Celgene + Bristol Myers Squibb), Akshata worked as a Flow Cytometry Scientist at Pfizer, Dept of Vaccine Therapeutics.