Altruist Biologics

This session will address the evolving CMC strategies required as the ADC landscape advances toward more potent and precise therapies. As manufacturers face the challenge of keeping pace with these developments, the discussion will explore practical strategies for streamlining manufacturing processes while maintaining product quality, scalability, and regulatory compliance for next-generation ADCs. The session will focus on optimizing bioconjugation techniques for dual-payload ADCs, covering both cysteine conjugation and amino acid incorporation methods for controlled payload attachment. Participants will learn about key manufacturing considerations essential for enabling site-specific conjugation while achieving scalability and consistency in production. Additionally, the presentation will cover the development of robust analytical methods and comprehensive CMC strategies designed to support global regulatory submissions for increasingly complex ADC products.

As biopharma companies increasingly seek to optimize the drug development timeline, China has emerged as a cost-effective biomanufacturing hub for both the rapidly growing Chinese market and the rest of the world. New localization guidelines set by the NMPA’s Center for Drug Evaluation encourage global companies to adopt a “China for China” manufacturing strategy for maximum commercial value creation. Achieving seamless drug production in China requires a strong partnership with an established CDMO who can help navigate China’s complex regulatory landscape and expedite the commercialization process. This session will explore the regulatory guidelines for localization as well as the key attributes global biopharma companies should look for in a reliable partner who can help leverage the opportunities and avoid the pitfalls to deliver quality outcomes.