Thursday, 5th March

CMC Day

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

Synopsis

  • 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

9:30 am Fine-Tuning Process Development, Scale-up & GMP Manufacturing of a Novel ADC Technology Platform

  • Dan Custar Associate Director - Drug Substance CMC, Mersana

Synopsis

  • 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

Synopsis

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

12:00 pm PROVEO: Complete Service Platform for Antibody Drug Conjugates

Synopsis

  • Simplification and components of ADCs supply chain
  • PROVEO Service platform
  • Integration of development and manufacturing activities
  • The good practice of communication
  • ADCs: Case studies from laboratory to cGMP

12:30 pm Lessons Learned During Drug Product Development of ADCs

Synopsis

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

1:00 pm Lunch & Networking

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

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

Synopsis

  • 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 Panel Discussion: Simplifying Your Global Manufacturing Supply Chain

Synopsis

  • 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

3:00 pm Chairs Closing Remarks

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