Conference Highlights Session 8 – Strategic Insights into CMC Program Design: Pioneering Biologics Development Excellence For the luncheon Session 8, entitled "Strategic Insights into CMC Program Design: Pioneering Biologics Development Excellence", four biologics manufacturing experts were invited to share their insights on Chemistry, Manufacturing, and Controls (CMC). Friedmund Bachman, Vice President of OncoOne Research & Development, Germany, outlined the numerous details to consider in CMC process development during biologics R&D. Hsing-Mao Chu, CEO of T-E Meds, discussed how his company develops complex next-generation antibody-drug conjugates (ADCs) through innovative multi-arm linker and proprietary drug bundle technologies. GeneQuantum Healthcare Chief Scientist Paul Song shared the development story of his company’s ADC technology and the manufacturing advantages brought by its unique antibody drug conjugation technology. Taron Solutions CEO Alan Chang shared global trends and observations in drug CMC design, pointing out that failed drugs are often due to design issues. Therefore, the earlier problems in drug development are identified and resolved, the higher the success rate of the drugs.
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