Insights
Regulation, quality control and the cold chain, explained plainly for the people who make mRNA medicines.
3 min read
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.
3 min read
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.
3 min read
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.
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