We All Have Baggage: A Deep Dive Into the Characterization of a Complex cIEF Electropherogram From an Antibody-Drug Conjugate Using a Novel Integrated icIEF-UV/MS System

Gain multiple pieces of critical data on complex biotherapeutics up front. Join the discussion about a novel platform for intact protein analysis and charge variant identification when working with ADCs using the Intabio ZT system.

Register Free: https://www.biopharminternational.com/bp_w/characterization

Event Overview:

Charge heterogeneity is present in most biopharmaceutical protein products. For antibody-drug conjugates (ADCs) the antibody, the linker, and the payload all contribute to the heterogeneity, which adds complexity to the charge variant profiles. Isolation and identification of charge variants is important in product characterization and manufacturing control strategy development.
Capillary isoelectric focusing (cIEF) is a popular technique for monitoring protein charge heterogeneity. However, direct peak identification from electropherograms often requires extensive lab work, including orthogonal LC method development, fractionation, offline MS characterization, and multiple cIEF re-analysis.

This webinar discusses the evaluation of a novel integrated icIEF-UV/MS system to identify and monitor the charged modifications on the ADC payloads in near real-time and disentangle the contribution of the payload from the antibody modifications.

• Reduce charge heterogeneity analysis workflow from weeks to minutes.
• Elucidate critical post-translational modifications (PTMs), including glycosylation, deamidation, and payload modifications.
• Enable mass characterization of charge variants and payload modifications of intact ADCs.
• Monitor charged modifications on ADC payload in near real-time with the Intabio ZT system.

Key Learning Objectives

• The importance of monitoring charge modifications during drug development
• The use of icIEF-UV/MS to accelerate intact protein analysis
• Recommendations to accelerate development timelines with an icIEF-UV/MS workflow

Who Should Attend

• Biotherapeutics Development scientists
• Cell Line Development scientists
• Process Development scientists

Speaker:

Kristin Schultz-Kuszak
Astra Zeneca

Kristin Schultz-Kuszak loves applying analytical chemistry methods to study biological systems. She received her Bachelor of Arts degree from Lawrence University and then traveled East to pursue a Ph D (University of Michigan). Her previous work focused on utilizing Capillary Electrophoresis (CE) to study neurotransmitter release to elucidate the mechanism behind sex differences in drug addiction. After graduation, she worked a postdoctoral position at the National Institute on Drug Abuse in Tony Shippenberg’s lab. Kristin quickly realized that she found more joy in helping others run the CE instrument than executing the in vivo studies. She then took a position at the Center for Biologics Evaluation and Research at the FDA as a Commissioner’s Fellow. After reading one too many generic drug applications, she realized that she wanted to return to the lab. Kristin then accepted a job at Medimmune (now AstraZeneca) in the Physical-chemical Methods Development group, where she learned all the electro methods. Capillary Isoelectric Focusing (cIEF) became her favorite method and she quickly became the go-to person for all things related to cIEF. Currently, she is the Lead Electrophoresis Subject Matter Expert with AstraZeneca. She also serves as the Analytical Representative on several chemistry, manufacturing, and control teams. Kristin is an active contributor to CASSS, serving as a committee member for the CE Pharm Conference and the DC Area Discussion Group.

Register Free: https://www.biopharminternational.com/bp_w/characterization