Innovating Manufacturing: Navigating The Nuances Of Process And Analytical Development For Decentralized Production

In this panel, Josh Ludwig (Global Commercial Director, ScaleReady) and Stuart Curbishley (Chief Manufacturing & Development Officer, Adthera Bio) explore the intricate challenges in transitioning cell therapy processes from research to Good Manufacturing Practice (GMP) compliance. Themes such as tool selection, scalability, digital solutions, supply chain logistics, regulatory compliance, raw materials, equipment standardization, and innovative training methods are discussed. Stressing the significance of early validation, adherence to regulatory standards, and process optimization, the dialogue provides insights into the complexities of achieving GMP compliance in decentralized manufacturing settings for cell therapies.