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
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
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)
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
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