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1st CMC Day
Wednesday October, 9

9.00 Chair’s Opening Remarks

Michael Kaufman, Senior Vice President - Chemistry, Manufacturing & Controls, Mersana

9.10 Keynote: Considerations for Scaling Up Your Manufacturing Operations from Phase II & Beyond

  • CMC strategic considerations for advancing ADC to late phase development
  • An example of process changes and demonstration of comparability

Ying Buechler, Vice President, Development, Ambrx

9.40 PROVEO: Fast Track Your End to End Solution for Antibody Drug Conjugates

  • The PROVEO™ Alliance combines the strengths and expertise of industry leaders into one solution
  • From Antibody Production, trough conjugation and Fill & Finish to Labeling and Packaging, PROVEO delivers a streamlined solution tailored to your ADC needs

Matteo Piazza, Business Development Manager, Cerbios

10.10 Speed Networking

10.40 Morning Break

11.30 Process Development & Comparison of Analytical Approaches for a Novel Chemical Site-Specific

• Overview of the site-selective conjugation of antibodies through the use of a novel class of IgG Fc-affinity peptide reagents to install payload-compatible linkers to well-defined amino acid residues
• Process development for scale-up ADC preparation suitable for GLP toxicological studies
• Comparison of six different analytical techniques to measure DAR and Proof of site-selectivity using peptide mapping

 

Yutaka Matsuda, ADC Researcher, Ajinomoto Bio-Pharma Services

12.00 Using Conjugation Process Purification Capabilities to Support Small-molecule & Bulk Drug Substance Specifications

• Immunogen’s approach of using fate/purge studies performed around the conjugation purification process to support small-molecule specification justifications will be discussed
• An overview of worst-case conjugation studies performed to characterize the clearance capacity of the purification process of individual process-related impurities will be given
• A case study for an early stage and late stage program will be presented

Scott Hilderbrand, Senior Scientist Conjugation Process Development, ImmunoGen

Solving Formulation & Fill Finish Challenges

12.30 HPAPIs & ADCs – A Journey Through High Potency

  • CASE STUDY: the development, rapid scaling and commercial production of HPAPI drug substance
  • Integrated containment requirements for particle engineering and drug products
  • Advantages of seamless integration of HPAPI and ADC operations
  • Impact of supporting integrated service-offerings on expansion strategies

David Lyon, Senior Fellow, Research Lonza Pharma & Biotech, Lonza

1.00 Lunch & Networking

Case Studies: Sharing Insights for Overcoming Manufacturing Roadblocks

2.00 Strategies for Late-stage ADC Product Characterization

  • Product characterization: actionable information to enable QBD
  • Strategies to address the challenges of ADC charge-variant characterization
  • A look to the future: the role of attribute-specific product and process characterization

Scott Henry, Principal Scientist - Analytical Sciences, Seattle Genetics

2.30 Fine-Tuning Process Development, Scale-up & GMP Manufacturing of a Novel ADC Technology Platform

• Overview of complex supply chain architecture for ADC manufacturing
• QbD-based strategy to process validation of key process intermediates
• Process scale-up Case Studies

Engin Ayturk, Director, CMC Process Engineering & BioConjugation, Mersana

3.00 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

Jens Lohrmann, Ying Buechler, Michael Sun 

3.30 Chair’s Closing Remarks

Michael Kaufman, Senior Vice President - Chemistry, Manufacturing & Controls, Mersana