8:15 am Check-In & Coffee
9:10 am Chair’s Opening Remarks
Ensuring High & Consistent Drug Substance Quality to Adhere to ADC Regulatory Control Strategies
9:15 am Considerations for Critical Quality Attributes and Control Strategy for Site Specific Antibody Drug Conjugates
Synopsis
- Overview of the critical quality attributes (CQAs) specific to Antibody-Drug Conjugates (ADCs)
- Identification of appropriate control points for monitoring ADC CQAs
- Exploration of control strategies for ADCs, including setting appropriate control limits
9:45 am Establishing Comparability for Antibody Drug Conjugates – A Regulatory Perspective
Synopsis
- Understand the regulatory landscape for ADCs
- Assess challenges in establishing comparability in ADCs
- Case study – how to establish comparability in ADCs based on mechanism of action
10:15 am Morning Break & Speed Networking
Synopsis
This informal session will provide the process development community valuable networking time, enabling you to forge new and lasting connections to plot paths to see future successes within the field.
11:15 am CMC Regulatory Considerations for Setting Small Molecule Impurity & Control Strategies
Synopsis
- Understanding the regulatory frameworks for an ADC to reflect the production processes and the combined approach to quality
- Justifying the specification setting for small molecule impurity limits
- Regulatory benchmarking of critical quality attributes and control strategies for marketed ADC products
11:45 am Roundtable Discussion – Setting Optimal CQAs to Ensure Appropriate Impurity Removal & Achieve Regulatory Approval
Synopsis
- Discussing standardized general control strategy for ADCs
- Understanding what the “must-do” aspects of process development are, and what can be deferred for IND approval, in order to improve cost and speed
12:30 pm Networking Lunch
Maximizing ADC Process Efficiency Through Unlocking Maximum Conjugation Yield
1:30 pm Technical Challenges & Opportunities in Early-Stage ADC Process Development & Manufacturing
Synopsis
- Evaluating challenges specific to early-stage ADC process development and manufacturing
- Highlighting strategies across drug-linker, mAb, DS, and DP
- Ensuring effective clinical supply for early-stage manufacturing
2:00 pm Panel Discussion – Optimizing Conjugation Processes to Decrease Heterogeneity & Prepare for Scale-Up
Synopsis
- Understanding the quantity of mAb fragments which must be removed and what can be dosed in small amounts
- Considering the conjugation technology and conditions used as well as their upscale applications
- Creating a platform to increase conjugation yield
2:45 pm Afternoon Networking Break
Anticipating Specific Strategies to Onboard Your Drug Product Development Decrease Costs & Improve Timelines
3:15 pm Safety Challenges and Hierarchy of Controls to Ensure Employee Wellbeing During ADC Production
Synopsis
- General ADC production outline
- Challenges we face in ADC production during clinical ADC production
- Hierarchy of controls we employ to deal with SAFETY and wellbeing of employees while managing production challenges, including: PPE & admin controls, engineering controls, substitutions & elimination of risks & opportunities in ADC production
3:45 pm Chair’s Closing Remarks
4:00 pm Networking Drinks Reception
Synopsis
A great opportunity to build relationships in a relaxed setting, expand your network, share insights, and discover business opportunities.