Speaker:
Aleš Štrancar, Managing Director, Sartorius BIA Separations
Abstract:
A new purification approach starting from E.Coli all through to mRNA production is presented here. This new approach integrates a pDNA linearisation step before polishing (removal of linear and open circular isoforms) of plasmid DNA. The polishing step, placed after enzymatic linearisation, purifies linear pDNA from enzyme and other unwanted process impurities. The linearised plasmid DNA is then used in IVT for production of mRNA. Fast in-process analytics allows for transcription number well above 100 in reproducible manner.
This approach further introduces mRNA purification tools for improved contaminant removal. The altered sequence of purification and linearisation reduces the overall number of purification steps required, improves recoveries, while the complete process results in extra low protein impurity and very efficient dsRNA removal.
The participants would get insight into the mRNA production steps, their optimisation and tools to allow for robust process. The analytical tools to allow for safe product will be highlighted, too.
