ADC End-to-End (E2E) Development & Control Strategy to Enable Best Process at Launch (BPAL)
Time: 9:00 am
day: Pre-Conference Workshop Day
Details:
ADC is a complex modality that is rapidly growing in the last 5 years, but there is no regulatory guidance to industry specific to ADC development. When upscaling and speeding up your processes, your control strategy and tolerance for risk are crucial in creating a roadmap for success. Challenges including understanding the necessary equipment, technologies and conditions required ahead of time can prove incomparable in streamlining your upscaling process.
Join this workshop to explore the industry practices on the following topics:
• Science- and Risk-based Approach for DS and DP development
• End-to-End Control Strategy (including ATS, specification)
• Production and Process Development Facility (including lab design, equipment)
• Regulatory and Dossier Strategy
