Notes on mRNA manufacturing quality, regulation and the cold chain.https://nucleynbiotech.com/enhttps://nucleynbiotech.com/insights/ema-2025-mrna-quality-guidance/https://nucleynbiotech.com/insights/ema-2025-mrna-quality-guidance/In 2025 the European Medicines Agency published a draft guideline on the quality of mRNA vaccines. Here is what it says about RNA integrity, and why that matters for testing during production.Thu, 01 Oct 2026 00:00:00 GMTSamkit Shahhttps://nucleynbiotech.com/insights/hidden-cost-mrna-cold-chain/https://nucleynbiotech.com/insights/hidden-cost-mrna-cold-chain/The first mRNA vaccines had to be kept frozen, one of them far colder than an ordinary freezer can go. Here is what that means for cost, for logistics and for who can be reached.Thu, 01 Oct 2026 00:00:00 GMTSamkit Shahhttps://nucleynbiotech.com/insights/mrna-qc-central-lab/https://nucleynbiotech.com/insights/mrna-qc-central-lab/The methods named in regulatory guidance for mRNA quality control are powerful, and they live in specialised labs. Here is what they involve, and why that creates a bottleneck between production steps.Thu, 01 Oct 2026 00:00:00 GMTSamkit Shah