Pre-Conference Workshop Day
Tuesday | September 17 2024
8:00 am Coffee & Morning Check-In
Workshop A
9:00 am ADC End-to-End (E2E) Development & Control Strategy to Enable Best Process at Launch (BPAL)
Synopsis
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
12:00 pm Lunch Break & Networking
Workshop B
1:00 pm Transforming Conjugation Processes to Optimize ADC Homogeneity
Synopsis
The conjugation process is one of the key determinants in ensuring the homogeneity and stability of your ADC throughout its process development journey. With the ADC world ever-expanding, technologies that ensure a robust conjugation process with a high yield are of utmost importance.
Considering the increasing competition to get ADCs into the clinic, creating a conjugation process that can effectively deliver to timeframes and CQAs is crucial. Through presentations and roundtable discussions, you will learn how to optimize your ADC homogeneity efficiently, within increasing time constraints.
Join this workshop to:
- Explore site-specific conjugation methods for achieving uniform DAR
- Utilize advanced purification methods for isolating homogeneous ADCs from impurities
- Consider optimal conjugation parameters to enhance product yield, quality, and homogeneity