Pre-Conference Workshop Day
Tuesday 18th April 2023
Workshop A 9:00
Achieving Regulatory Compliance with Best Practices of Potency Assay Integration into mRNA Manufacturing Processes
- Anna Särnefält CMC Lead, Coalition for Epidemic Preparedness Innovations
- Camilla Foged Professor, University of Copenhagen
Potency assays are a key aspect of bringing a vaccine or therapeutic from bench to bedside but uncertainty exists about how they should be integrated into the manufacturing process to achieve regulatory compliance without compromising process efficiency.
Join this workshop to better understand this challenge and visualise the future of potency assays that are fully integrated into the manufacturing process.
- Determining potency in the context of mRNA vaccines and therapeutics to guide potency assay selection
- Exploring the most promising potency assays for integration into a streamlined manufacturing process
- Analysing the cost/benefit of integrating potency assays into the manufacturing process
Networking Break & Refreshments 12:00
Workshop B 13:00
Improving mRNA Batch Production & Maximising Biocomparability to Meet Global Market Demands
- Elaine Peters Director - Analytical, Individualized Cell & Gene Therapies, Genentech
- Roland Pach Global Expert - Cell Gene Therapy, Analytics Chemistry, Manufacturing & Controls, Roche
Batch production of mRNA therapeutics and vaccines introduces batch-tobatch variability which makes it challenging to claim biocomparability. This becomes an especially pressing issue when scaling up the manufacturing process to meet the demands of the global market while satisfying regulatory guidance.
Join this discussion to identify the key process steps that introduce batch-to-batch variability, how to measure this, and uncover the process development considerations to overcome these issues at scale.
- Determining the critical process steps that introduce batch-to-batchbvariability and the best analytical assays to measure these
- Controlling the manufacturing environment to minimise variability between batches and allow biocomparability
- Evaluating the extent of the impact of batch-to-batch variability on product quality