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Thursday, June 6 and Friday, June 7
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The physical and chemical properties of mRNA and pDNA, production process, and purity requirements for clinical material present significant challenges both for UPS and DSP development. In this workshop, Sartorius BIA Separations’ analytical scientists will demonstrate the use of PATfix® analytics with CIMac pDNA for cell lysis step and PrimaS for use in IVT optimization and DSP monitoring. For DSP scientists, the workshop will introduce different CIM® monolithic chromatographic media for the purification of mRNA and pDNA, describe techniques for the management of dsRNA and methods to improve process robustness during scale-up.
You will learn:
• How to implement PATfix analytics for cell lysis and IVT process optimization and process monitoring
• About affinity purification of mRNA from IVT
• About reversed-phase chromatography for analytics and removal of dsRNA from mRNA
• How to use selective hydrophobic interaction chromatography for reaching high purity of supercoiled pDNA to be used for linearization
• About continuous in-line lysis and its benefits:
• Alkaline lysis in typical pDNA purification is usually done in batch mode with challenges like controlling large volumes, NaOH exposure time and neutralizing step. Our in-line lysis system resolves this challenge, with addition to improve robustness and contaminant profile like genomic DNA and isoform homogeneity.
Who should attend?
• Process development scientist
• Purification development scientist
• DSP scientist
• Process engineer
• Analytical scientist