Plasmid DNA: How Good is Good Enough for mRNA Production?
Time: 10:00 am
day: Day Two
Details:
- Supercoiled DNA percentage is a key in-process control of linear DNA template for mRNA drug substance manufacturing
- Open circular DNA in plasmids caused by nicks, though won’t be reflected by the linear DNA purity, will directly impact mRNA major CQA as well as key process yield
- Four different processes, covering enzymatic capping and co-transcriptional capping, as well as non-affinity purification and affinity purification have been investigated
- The findings contribute insights into in-process control strategy for linear DNA template production and the determination of suitable processes for mRNA manufacturing
