From Detection to Mitigation: Managing Sequence Variants in Biotherapeutics

Sequence variants in protein therapeutics can significantly impact the biological activity of a drug. These mutations may alter protein structure, leading to undesirable immune responses in patients, compromising drug stability or reducing therapeutic efficacy. Detecting and controlling sequence variants is a critical regulatory requirement and early detection allows for necessary adjustments in the manufacturing process to ensure batch consistency.

This webinar will explore how to detect challenging sequence variants by applying an icIEF-UV/MS workflow on the Intabio ZT system. Additionally, we will discuss the subsequent characterization using EAD-enabled LC/MS methods on the ZenoTOF 7600 system. We will also explore a case study that highlights how a cell and developability science team identified a previously uncharacterized sequence variant in a CMC program, and utilized novel workflows to develop a mitigation strategy for monitoring this variant in current and future programs.

Key learnings for attendees:

• Impact of variants - Learn how sequence variants affect drug efficacy, stability and immune responses
• Detection methods -  Discover icIEF-UV/MS and EAD-enabled LC/MS techniques for identifying variants
• Case study - Gain insights from a real-world example of identifying and mitigating a sequence variant

Who should attend:

• Principal Scientist
• Senior Scientist
• Analytical Development
• Cell Line Development
• Associate Director