This webcast features: Bingquan (Stuart) Wang, PhD, Senior Director, US-EU CMC Management, WuXi XDC.

Antibody-drug conjugate (ADC), is one of the fastest growing fields in therapy for life-threatening diseases. Its novel mechanism of action, target for unmet serious diseases and significant therapeutic effect has led the expedited development and approval of several new ADC drugs.

However, ADC development presents unique and serious challenges. The combination of a large molecule and a small molecule increases complexity and therefore slows down progress. Producing the native antibody and the drug and linker requires multiple processes, as does drug substance conjugation and drug product manufacturing. Additionally, various assays are essential to support manufacturing, characterization, and release and stability testing. Overcoming these hurdles requires advanced CMC expertise and innovative technology.

Key Takeaways:

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