Thursday, 5th March


Analysing the Lessons Learned to Improve Scale Up

8:50 am Chairs Opening Remarks

  • Alain Beck Senior Director, Biologics CMC & developability, Pierre Fabre

9:00 am Product Understanding : The Challenge for Stochastic Conjugates to Prepare Charge Variants & Assess their Impacts on Critical Quality Attributes


  • Understand the requirement behind the Product Understanding & related challenges for charge variants issued from stochastic conjugates
  • Delve into the purification path to deliver charge variants
  • Share impact on Critical Quality -Attributes of these charge variants

10:00 am Fine-Tuning Process Development, Scale-up & GMP Manufacturing of a Novel ADC Technology Platform

  • Dan Custar Associate Director - Drug Substance CMC, Mersana


  • Overview of complex supply chain architecture for ADC manufacturing • Evaluating a QbD-based strategy to process validation of key process parameters
  • Analysing process scale-up case studies

10:00 am Speed Networking

10:50 am Morning Refreshments

Analytical Lessons Learned from Commercial Manufacturing for ADCs

11:30 am ADC CMC & Developability: Input of State-of-the-Art Analytical Methods

  • Alain Beck Senior Director, Biologics CMC & developability, Pierre Fabre


  • Demonstrating Quality Target Product Profile and Critical Quality Attributes
  • Reviewing multilevel and multidimensional analytical methods
  • Discussing structure assessment and quality control

12:00 pm Lessons Learned During Drug Product Development of ADCs


  •  Tackling stability and formulation challenges
  • Exploring new processes and establishing external partnerships
  • Addressing issues during clinical administration
  • Assessing ADC lyophilization cycle development

12:30 pm Lunch & Networking

1:00 pm Mastermind Session: ADC Formulation/Fill Finish Development readying for Commercial Scale Manufacturing


  • More practical and highly interactive breakout roundtables where attendees can crowd-source 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
  • Discussing solutions to overcome aggregation challenges
  • Case studies on progressive formulation and fill finish methods

2:00 pm ADCs Developability Assessment: from Research to Development of New Candidates

  • Pierre Guibal Deputy Head, Analytical Development, BioAnalytics, Sanofi


  • Evaluation of new candidates for a given target based on limited characterization data
  • Early stability assessment by means of short-term stress study
  • Criteria for selection of best candidates for development

2:30 pm From Research to Commercial: A Conjugation Scale-up Primer

  • Rich Reynolds Principal Scientist, Conjugation Process Development, Seattle Genetics


  • What is involved in scale-up beyond volume
  • What are the challenges from development to Phase I and beyond
  • Managing expectations in moving to GMP manufacturing


3:00 pm Panel Discussion: Simplifying Your Global Manufacturing Supply Chain


  • What went wrong? Discussing lessons learned from managing late stage manufacturing supply chains
  • Effectively managing complex global supply chains
  • Exploring opportunities to work with partners in emerging ADC geos such as Asia

3:30 pm Chairs Closing Remarks

  • Alain Beck Senior Director, Biologics CMC & developability, Pierre Fabre