Proven Control Strategies for ADC/mAb Potency and HCP Analysis

Tuesday, November 11, 2025

11:15 AM - 12:00 PM CT

Location:Spotlight Stage B, Aisle 2500, Exhibit Hall

Sponsored By

Manufacturing and Analytical Characterization

Partner Presentation-Manufacturing & Bioprocessing

Chalk Talk Presenter(s)

Jessica Weaver, MRes (she/her/hers)

Scientific Officer
BioAgilytix Labs
Benson, North Carolina
Reema Davis, PhD

Manager, CMC Bioanalytical Operations
BioAgilytix
Durham, North Carolina

Potency and host cell protein (HCP) assays are critical for the characterization and control of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). This session will outline FDA and EMA expectations, highlight common assay development challenges, and share case studies with practical solutions. Attendees will gain insights into integrating potency and HCP analytics into robust ADC control strategies that support regulatory success.

Learning Objectives:

Interpret phase-appropriate regulatory requirements for potency and HCP testing.
Apply case study learnings to overcome common assay development and validation challenges.
Integrate potency and HCP analytics into ADC control strategies for regulatory compliance.