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 Optimizing the Post-Conjugation TFF Process to Improve Impurity Clearance & Increase Process Robustness
Synopsis
- Developing robust ADC manufacturing process
- Optimizing removal of drug-linker related impurities
- Improving the performance of TFF processes to reduce processing time
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 Panel 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 Afternoon Break
3:00 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.
Considering Process Characterization to Ensure the Robustness of Your Process Development to Reduce Risk of Batch Failure
3:30 pm Developing a Cell Based Assay for Evaluating the Potency of Engineered Monoclonal Antibodies to Improve Timings & Gain Regulatory Approval
Synopsis
- Discussing ways to improve timelines for cell-based assays with minimal costs
- Considering alternatives to cell-based assays and ion exchange chromatography to achieve regulatory approval
- Controlling antibody oscillation frequency through changes in cell culture