Pre-Conference Workshop Day
Tuesday, September 20
8:00 | Morning Networking Coffee
9:00 - 12:00
Defining mRNA Drug Substance Quality Control Attributes for mRNA Drug Product
mRNA technology now enables rapid development of vaccines and novel therapeutics. Likewise, quality control and assurance for manufacturing processes and lot release of mRNA are undergoing accelerated evolution. This workshop aims to determine strategies and methods for mRNA quality control and provide a better understanding of the quality requirements for process monitoring and lot release of mRNA-based vaccine and therapeutic products.
- What are key quality attributes and decisions for mRNA drug substance process?
- How to better understand and plan for regulatory expectations in terms of drug substance quality and process?
- How to define a quality control roadmap for effective process scale up and manufacturing?
Senior Director – Quality
Professor – Vaccine Design & Delivery
University of Copenhagen
12:00 - 1:00 | Networking Lunch Break
1:00 - 4:00
Addressing Regulatory Perspectives on Requirements for Effective mRNA Process Scale Up, Comparability & Analytics
With increasing investment in mRNA technology platforms and robust regulatory-specific frameworks for mRNA drug substance and product quality, it is now critical to streamline processes and provide greater clarity and guidance for this developing industry. This workshop aims to define the increasing requirements for process development, scale-up, comparability and analytics to ensure the identity, purity, potency, and safety of the product are not impacted by CMC changes
- Regulatory strategy for process development of a pandemic response
- How are the comparability regulatory requirements different for the various mRNA products – vaccines vs therapeutic drugs; rare disease mRNA drugs vs non-rare diseases; prophylactic vs treatment vaccines; COVID vaccines vs other infectious agent vaccines, etc.?
- What are the major hurdles in demonstrating comparability in different CMC changes (process improvement, process scale-up, formulation/excipient changes, CCS changes, etc) based on the participants’ experience?
- The integral role of analytics in mRNA process development and product release
Senior Director – Global Regulatory Affairs CMC
Director – Regulatory Affairs CMC
Vaccine Analytics LLC.
Professor - Sustainable Manufacturing Systems
King’s College London
Philippe Alexandre Gilbert
Senior Program Officer - CMC
Bill & Melinda Gates Foundation