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【JW Forum】Answers to Biologics Process Quality Control — The 2nd ADC & Novel Antibody Drug Process Quality Control Summit Concludes Perfectly!

Time2026-03-31
Views25

Today, the "2nd ADC & Novel Antibody Drug Process Quality Control Summit," hosted by Medispace, concluded successfully in Suzhou! With the core theme of "Smart Manufacturing · Quality Control · Breakthrough" for the first time, the summit brought together 408 pharmaceutical companies from across the country, 1,069 industry elites, experts, and pharmaceutical professionals, with 82 experts and pharmaceutical executives sharing insights across 7 professional and forward-looking thematic forums. In-depth exchanges were conducted on key areas such as process development, quality control, and analytical strategies for ADCs and complex multi-antibody drugs, delivering a thought feast that combined forward-looking vision with practical value.

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Against the backdrop of frequent successes in innovative drug global expansion and the rapid growth of novel antibody drugs at globally leading rates (ADC 79.4%, bispecific antibodies 54.3%), this summit precisely addressed a critical juncture in industry development. Attendees broadly agreed that breaking through process bottlenecks and strengthening quality control have become the core elements in driving China's transition from a "major pharmaceutical producer" to a "pharmaceutical powerhouse" and in completing the "last mile" of industrialization.

 

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During the conference, You Jiali, Technical Director of Jiangsu JV Bio-Equipment Co., Ltd., delivered a presentation titled "Integrating the 'Quality by Design' Concept into Biopharmaceutical Tank and Piping Systems," sharing cutting-edge practices and systematic solutions. Targeting common industry pain points such as low CIP cleaning efficiency and difficult microbial control, the core of her proposed approach is: define critical process parameters through precise engineering calculations, and continuously optimize sanitary design, dead-leg control, and fluid dynamics performance based on risk assessment—thereby building a robust and efficient production system within the design space, ultimately achieving an organic unity of product quality and production efficiency.

 

This approach of systematically solving quality control issues from the design source provides a clear and actionable direction for the industry. The on-site exchange atmosphere was lively, with engaging speeches and interactive sessions that effectively stimulated in-depth thinking among attendees on the evolution of biologics process technology and future industry development.9-6.jpeg

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Though the summit has come to a close, the new journey of China's novel antibody drugs into the hundred-billion-yuan market has only just set sail. We firmly believe that with continuous innovation in process smart manufacturing as the engine, and rigorous and reliable quality control as the cornerstone, through collaborative breakthroughs across the entire industry, China's innovative drugs will surely step onto the global stage with more steady and confident strides.

 

We extend our gratitude to all participating guests and partners for your active involvement and strong support. We look forward to reuniting and joining hands again to witness the next brilliant chapter of China's pharmaceutical innovation!