Improving mRNA Batch Production & Maximising Biocomparability to Meet Global Market Demands

Time: 1:15 pm
day: Pre-Conference Workshop Day


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.

Topics include:

  • 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