KBI Biologics Capacity Update October 2024: ADC

This presentation explores the critical aspects of late-stage characterization for antibody-drug conjugates (ADCs) and its integral role in a robust analytical control strategy, which is essential for successful marketing applications. We will begin by explaining the importance of product characterization and its necessity, followed by an outline of how it integrates into the control strategy. This includes a focus on its role throughout the entire process, from preclinical development to commercial production.

Key Topics Include:

1. Product Characterization:

   • Importance, steps, and their impact on safety, efficacy, stability, and overall performance.

2. Control Strategy Integration:

   • How characterization supports the Quality Target Product Profile (QTPP) and defines critical quality attributes (CQAs).

3. Case Study:

   • An in-depth examination of an ADC characterization project at KBI Biopharma, highlighting methodologies, challenges faced, and data analysis.

Review the essential role of comprehensive characterization in ensuring that ADCs not only meet regulatory standards but also achieve therapeutic goals for patients with critical needs by watching the video below.