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

Solving Formulation & Fill Finish Challenges

11.30 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

12.00 Panel Discussion: ADC Formulation/Fill Finish Development readying for Commercial Scale Manufacturing

Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtables, they will present back to the entire delegation as part of a panel discussion for an interactive debate and discussion

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 Title TBC

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