1.) Course Description
In this workshop, the use of the Alkalizator, an in-line lysis system that offers efficient mixing, resulting in a highly controlled and scalable process, will be demonstrated. This leads to excellent cell debris separation and lower contaminant levels, including gDNA, RNA, and OC pDNA. Due to high regulatory requirements for the purity of the final product, the majority of plasmid DNA downstream processes are based on chromatography. Discover how Convective Interaction Media (CIM) monoliths offer several advantages for large molecules such as pDNA, thanks to their large channels, high surface accessibility, and low shear forces.
The physical and chemical properties of mRNA, along with production processes and purity requirements for clinical material, present significant challenges for both upstream and downstream development. This workshop will demonstrate the use of a chromatographic assay with CIMac PrimaS for in vitro transcription (IVT) optimization and downstream monitoring. It will introduce different CIM monolithic chromatographic media for the purification of mRNA, describe techniques for the management of dsRNA, and methods to improve process robustness during scale-up.
2.) Who Should Attend?
◾︎Process development scientist
◾︎Purification development scientist
◾︎DSP scientist
◾︎Process engineer
◾︎Analytical scientist
3.) Key Learnings
◾︎Learn about in-line lysis with Alkalizator, for a highly controlled and scalable process of pDNA extraction from bacterial cells.
◾︎Learn how to use different chromatographic approaches for the capture and polish of pDNA in order to reach high purity of supercoiled DNA plasmids that can be also used for linearization.
◾︎Learn how to implement CIMac PrimaS as an analytical tool for IVT process optimization and downstream process monitoring.
◾︎Learn about affinity and multi-modal purification of mRNA from IVT reactions.
◾︎Learn about different chromatographic approaches for removal of dsRNA from mRNA samples.