8:30 am Check-In & Coffee

9:20 am Chair’s Opening Remarks

Optimizing Purification Strategies to Tackle Free Payload Impurities & Decrease Unit Operations

9:30 am Development of a Membrane-Based Hydrophobic-Interaction Purification Step for a Lysine-Conjugated ADC

  • Nimish Gupta Senior Staff Engineer, Regeneron Pharmaceuticals

Synopsis

  • Performing resin screening to determine preferred purification media
  • Understanding process levers that impact impurity clearance
  • Building predictive models to determine preferred conditions for operation

10:00 am Developing a Novel Non-Chromatographic Purification for ADCs: Moving Beyond UF/DF

  • Brandon Coyle Associate Director & Senior Research Scientist, Gilead Sciences

Synopsis

  • Surveying alternative purification strategies
  • Developing novel purification of CL2A-SN38 impurities
  • Evaluating characterization strategies for new purification technologies

10:30 am Morning Break & Speed Networking

Synopsis

This is an informal session to help you connect with your peers in a relaxed atmosphere and forge new and beneficial relationships. With an audience of experts in toxicology eager to discuss shared challenges, you will have the opportunity to display a poster presenting your own work. Additionally, you will have the chance to review others’ posters.

To submit a poster, please contact info@hansonwade.com

Considering Process Characterization to Ensure the Robustness of Your Process Development to Reduce Risk of Batch Failure

11:30 am Process and Analytical Development of Drug-Fc Conjugates (DFCs)

  • Robert Hughes Senior Director, Pharmaceutical Sciences, Cidara Therapeutics Inc.

Synopsis

  • Evaluate Cidara Therapeutics’ DFCs developments to address serious diseases
  • Compare and expand upon the strengths of small molecules and antibody therapeutics using the uniquely tunable DFCs platform
  • Address the unique challenges associated with each DFCs product development, considering disease area, dose regimen, and properties

12:00 pm Evaluating the Correct Timings to Introduce Process Characterization to Assess the Robustness of Your ADC Process Development

Synopsis

  • Reviewing considerations in FIH and commercial process development and their impact in process characterization strategy
  • Deciding when to start your process characterization experiments dependent on your timelines
  • Discussing advances in analytical techniques for the characterization of a manufacturing process

12:30 pm Networking Lunch

Handling Deviations & Safety Challenges When Manufacturing ADCs Ensure Employee Wellbeing

1:30 pm Roundtable Discussion – Accelerating Process Development Scale-Up to Manufacturing for ADCs

  • Dharti Kothari Senior Scientist - Downstream Process Development, Exelixis

Synopsis

  • Addressing the largest challenges posed to both process development scientists and manufacturers when accelerating scale-up processes
  • Considering potential solutions for a more streamlined scale-up process through inter-departmental collaboration
  • Delving into how service providers can aid with scale-up of ADC process development

2:15 pm Creating a Corrective & Preventative Action Framework for Overcoming Deviation Challenges in ADC Manufacturing

Synopsis

  • Identifying and investigating deviations, and implementing corrective actions
  • Preventive actions, documentation, and ongoing monitoring
  • Ensuring compliance with regulatory standards and guidelines

Understanding the Necessary Analytical Approaches to Optimize the Process Development of ADCs

2:45 pm Analytical and Biological Characterization of ADCs to Support Process Development Decisions

Synopsis

  • Discussing the pros and cons of binding vs cell-based potency methods
  • Understanding the differences in assay sensitivities to CQAs and its biological relevance
  • Exploring a case study to support cell culture process development

3:15 pm Chair’s Closing Remarks

3:25 pm End of Conference Day Two