Pre-Conference Workshop Day

Tuesday | September 17 2024

8:00 am Coffee & Morning Check-In

Workshop A

9:00 am Transforming Conjugation Processes to Optimize ADC Homogeneity

  • Nimish Gupta Senior Staff Engineer, Regeneron Pharmaceuticals Inc
  • Eric Lacoste Head of ADC Conjugation Development/Global CMC Development, Sanofi

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

12:00 pm Lunch Break & Networking

Workshop B

1:00 pm Setting Your Specifications & Level of Risk Appropriately to Enable Seamless Upscaling

  • Hong Shen Principal Scientist, Johnson & Johnson Services, Inc

Synopsis

When upscaling and speeding up your processes, your specifications and tolerance for risk are crucial in creating a roadmap for success. Without outlining necessary specifications, there is risk of batch failure and slower timeframes. Challenges include understanding the necessary equipment, technologies and conditions required ahead of time, which can prove incomparable in streamlining your upscaling process.

Join this workshop to:

  • Design your lab to be more representative to full-scale processes to streamline upscaling
  • Understand how narrow to set your specifications to achieve low-risk but high reward results larger scale
  • Prioritize and prepare for when to outsource from your CDMO to improve time frames

4:00 pm End of Pre-Conference Workshop Day