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Opening Address & Keynote Presentation: Dynamic Process and Analytical Control Strategy for Pharmaceutical Manufacturing and Control Through Evolving Automation, Digitalization/AI and Risk Based Approaches
Outcome‑driven manufacturing control strategies are rapidly evolving—shifting from static, end‑product testing to dynamic, data‑driven lifecycle management across biologics and cell therapies.
This session will explore how patient‑centric controls, operational risk management, advanced technologies, automation, PAT, and digitalization can be integrated to strengthen quality, stabilize supply, and accelerate decision‑making across complex manufacturing environments.
Through real‑world examples, the session will highlight practical approaches that enable more reliable, scalable, and resilient manufacturing systems—supporting the future of biologics and cell therapy production.
This session will explore how patient‑centric controls, operational risk management, advanced technologies, automation, PAT, and digitalization can be integrated to strengthen quality, stabilize supply, and accelerate decision‑making across complex manufacturing environments.
Through real‑world examples, the session will highlight practical approaches that enable more reliable, scalable, and resilient manufacturing systems—supporting the future of biologics and cell therapy production.
