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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

  • Eric Lacoste Head of Bio-Organic Team & Chemistry, Manufacturing, Control & Project Manager, Sanofi

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

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

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 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

12:30 pm Lunch & Networking

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

Synopsis

  • 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 Process Characterization Case Study of a Scale-down Model Qualification & Related Proven Acceptable Range Study

  • Eric Lacoste Head of Bio-Organic Team & Chemistry, Manufacturing, Control & Project Manager, Sanofi

Synopsis

  • Understand the requirement behind the Process Characterization
  • Gain insight on Scale-Down Model (SDM) definition & qualification
  • Share results of the Prove Acceptable Range study for this SDM

2:30 pm Effectively Planning Late Stage Manufacturing Supply Chains to Effectively Meet Timelines

3:00 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

3:30 pm Chairs Closing Remarks

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