Developing a fit-for-purpose release testing strategy for ADCs

With approximately 20 antibody drug conjugates (ADCs) approved globally and more than 200 in clinical trials, the ADC field is expanding rapidly. This growing pipeline and increasing number of approved products are placing greater emphasis on robust and effective approaches to ADC quality control and drug product release testing.

ADCs present unique challenges for quality control, requiring careful consideration of the monoclonal antibody, linker and payload, as well as the final conjugated product. These complexities also present particular challenges when developing an effective drug product release testing strategy.

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Alongside established testing such as potency and sterility, it is important to assess attributes including drug-to-antibody ratio (DAR), unconjugated antibody and free drug-related impurities (FDRIs), which can have implications for product quality, efficacy and safety.

In this webinar, we will explore the key challenges and pitfalls in developing a fit-for-purpose, cGMP-ready ADC release testing strategy, as well as practical approaches for addressing them.

What you will learn:

• Developing a fit-for-purpose ADC release testing strategy aligned with cGMP requirements
• Understanding the importance of DAR and selecting appropriate analytical methods for its assessment
• Selecting potency and binding assays to demonstrate product quality
• Monitoring unconjugated antibody and free drug-related impurities (FDRIs)
• Integrating safety and sterility testing into the ADC release strategy

Secure your place for this webinar today