Characterization & Control Strategy for an ADC

Originally hosted at BPI East, this presentation highlights the critical aspects of late-stage characterization for antibody-drug conjugates (ADCs) and their role in a robust analytical control strategy essential for successful marketing applications.

Overview

Product characterization is the cornerstone of safe, effective, and compliant biotherapeutic development. In this session, Deanna Hunt, Senior Director of Business Development at KBI Biopharma, unpacks the intricacies of antibody-drug conjugates (ADCs) characterization, exploring how advanced analytics and control strategies pave the way for regulatory success and optimized therapeutic performance.

Key topics:

• Product Characterization: Importance, steps, and impact on safety, efficacy, stability, and performance.
• Control Strategy Integration: How characterization supports the Quality Target Product Profile (QTPP) and defines critical quality attributes (CQAs).
• Case Study: An ADC characterization project at KBI Biopharma, showcasing methodologies, challenges, and data analysis.

Presenter

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