Conference Day Two

Thursday 21st September 2023

8:50 Chair’s Opening Remarks

Transforming Conjugation Processes to Ensure High Conjugation Yield

9:00 am Considerations for Conjugation Process Characterization Before PPQ

Synopsis

• Understanding the framework for the development and characterization of a manufacturing process

• Delving into learnings from process characterization

• Analyzing metrics of process readiness for PPQ and their application

9:30 am Understanding Challenges to Large Scale Conjugation Manufacturing

  • Megan Long Manufacturing Purification Manager, Seagen

Synopsis

• Highlighting challenges faced bringing drug linker solubilization process step in house

• Highlighting challenges faced scaling up conjugation process to large scale commercial manufacturing

• Overcoming complexity with conjugation to accelerate process development

10:00 am Roundtable Discussion – Harnessing Developments in Conjugation Tools & Equipment to Optimize ADC Process Development

  • Christian Lutz Director - Project Management CMC, Heidelberg Pharma Research

Synopsis

• Highlighting the need for standardized tools

• Matchmaking the correct tools and equipment to the ADC that you are manufacturing

• Stating and highlighting the importance of selecting the right equipment for your process

10:45 Morning Break & Networking

Optimizing Approaches to Creating a High Quality Drug Product

11:45 am Phase Appropriate Platform Approach for Drug Product Process Development from IND to BLA

Synopsis

  • Introduction of ADC Therapeutics 
  • Process Development roadmap of Zynlonta
  • Platform approach from early phase to commercialization – advantages and points to consider
  • Management/Collaboration of Contract Manufacturing partners 

12:15 pm Advancing AstraZeneca’s Antibody Drug Conjugate Pipeline – Building Internal Capabilities

Synopsis

• ADC process development

• ADC manufacturing processes

• Safety considerations for ADC manufacturing processes

12:45 Networking Lunch

1:45 pm Roundtable Discussion – Evaluating the Future of Drug Product Design to Understand the Direction in Which to Formulate Your ADCs

Synopsis

• Understanding where drug product design is heading

• Comparing and contrasting the process behind creating different forms of drug product

• Exploring the advantages and challenges of novel drug product designs

2:15 pm Process development considerations for an ADC with a cleavable drug linker

Synopsis

• Why inherently unstable linkers may be an important tool for next generation ADC's

• Developing efficient purification techniques for free drug related impurities that generate in real time

• Maintaining effective and transparent communication with CMO network to optimize tech transfer

2:45 pm Drug-To-Antibody Determination for an Antibody-Drug-Conjugate Utilizing Cathepsin B Digestion Coupled with Reversed-Phase High-Pressure Liquid Chromatography Analysis

Synopsis

• Analytical challenges for random conjugation ADCs

• Developing a novel method for determining drug-to-antibody ratio

• Understanding method performance and critical conditions

Highlighting Novel Formulations to Understand Their Advantages Over Traditional Ones

3:15 pm Panel Discussion – Lyophilization vs Liquid Formulations- Discussing the Benefits & Drawbacks of Both

Synopsis

• Analyzing the advantages of both formulations 

• Comparing both to understand when one should be used over the other

• Selecting the best use case for each formulation

4:00 Chair’s Closing Remarks

4:15 End of Conference