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

• Advantage of applying Ambrx technology to make ADCs
• ARX788 development and manufacturing strategy
• ARX788 comparability strategy and study results addressing process changes

Ying Buechler, Vice President, Development, Ambrx

9.40 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

Daniel Milano, Senior Engineer, Conjugation Process Development, ImmunoGen

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

Solving Formulation & Fill Finish Challenges

12.00 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

12.30 Lunch & Networking

Case Studies: Sharing Insights for Overcoming Manufacturing Roadblocks

1.30 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

2.00 Challenges & Lessons Learned in ADC CMC Development & Outsourcing

• Buy vs. make: considerations and critical success factors
• Scale-up and site transfer of a conjugation process with impact on key product quality attributes: a case study
• Analytical transfers: considerations & lessons learned from a challenging assay transfers

Jens Lohrmann, Head of Disease Area, Oncology & Technical Development Novel Biologic Entities, Senior Manager - Global Program & Translational, Novartis

2.30 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, Head of Disease Area, Oncology & Technical Development Novel Biologic Entities, Senior Manager - Global Program & Translational, Novartis

3.00 Afternoon Break & Networking

Analytical Lessons Learned from Commercial Manufacturing for FDA Approved ADCs

4.00 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

4.30 Lessons Learned from “Back-to-Back” Regulatory Submissions for Two ADC Products

• Learn how to streamline the processes
• Planning ahead – process validation and control strategy
• Effectively and efficiently prepare for PAI

Katherine Mikulka, Manager Technical Services, Oncology Operations, Pfizer

5.00 Chair’s Closing Remarks

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