4th-6th March 2019

3rd Analytical & Bioanalytical Day

3rd Analytical & Bioanalytical Day | Monday 4th March

08.30   Chair’s Opening Remarks

Alain Beck, Senior Director, Biologics CMC & Developability, Pierre Fabre

08.40 Moving Beyond the Simplistic; Novel Analytical Methods for ADC Characterisation & Assessment

• Discussing evolution of analytical methods for ADC characterisation
• Assessing novel analytical methods for analytical characterisation of next-generation ADCs
• Reviewing application of optimised analytical methods for ADC research

Alain Beck, Senior Director, Biologics CMC & Developability, Pierre Fabre

Integrating a Robust Bioanalytical Support Strategy

09.10 Strategies & Challenges for Developing Total Antibody & Antibody Conjugated Drug 2-in-1 Method for Dolaflexin Antibody Drug Conjugates

• High throughput 96-well sample preparation approach
• Total antibody and antibody conjugated drug in one assay
• Non-clinical and clinical assays

Ling Xu, Principal Scientist, Mersana Therapeutics

09.40 Speed Networking

10.40 Morning Refreshments

11.30 Panel: Predicting Efficacy/Tox Relationships through Modelling of ADC Distribution & Biotransformation

• Quantification and characterisation of intact ADC and intermediates, predicticting toxicities and efficacies
• Process chemistry changes in mAb vs conjugation vs small molecule
• What are the gaps in our analytical capability?

12.00 Think Tank Roundtable Sessions
More practical and highly interactive breakout roundtables where attendees can crowdsource solutions and share opinions around pre-assigned topic areas. A valuable chance for attendees to unite around hot topics and debate best practice. No more sitting quietly, this is a dedicated opportunity for you to voice your experiences and identify unique solutions. There will be two 45 minute sessions with the opportunity to change groups halfway through.

13.00 Lunch & Networking

What Happens When it Gets Tricky?

14.00 Leveraging Prior Knowledge to Gain Efficiencies During Product Characterisation of Antibody Drug Conjugates

• Seattle Genetics has developed a deep product understanding of Antibody Drug Conjugates
• As we continue to build our pipeline, accommodate an ever increasing need for speed to clinic and market, we continue to explore opportunities to gain efficiencies. Leveraging prior knowledge gained from multiple product characterization efforts can help realize some of these efficiencies
• This presentation will show a comparison of size & charge variant characterization results for multiple ADCs to highlight common modifications and structural variants across ADCs. Based on this data we propose a streamlined and targeted approach to product characterization that takes advantage of prior knowledge

Nomalie Jaya, Principal Scientist, Seattle Genetics

14.30 What are the Best Tools to Implement in Robust Characterisation of CQAs

• Developing analytical strategies that account for product variability
• Reviewing how antibody variants can impact the quality attributes of ADCs
• Appropriate analytical strategies are needed to monitor the variants of antibodies and their corresponding immunoconjugates in order to assure consistent product quality

Karan Shah, Development, Analytical Chemistry ImmunoGen

15.00 The Characterisation Strategy in Outsourcing: from Manufacturing to lot Release

• In process testing at each stage in manufacturing and across vendors
• Method validation at various stages in the process
• The product quality assessment: comparability, release and stability testing

Esohe Idusogie, Head, Process Quality & CMC Analytical, ADC Therapeutics

15.30 Chair’s Closing Remarks:

Alain Beck, Senior Director, Biologics CMC & Developability, Pierre Fabre