Composition of fully in vitro transcribed RNA available by a process for the production and purification of RNA with at least one step with tangential flow filtration

摘要

Composition of fully in vitro transcribed RNA available by a procedure including the steps:A) providing DNA coding for the RNA;B) In vitro transcription of DNA to obtain a solution that includes transcribed RNA; andC) Diafiltration and/or concentration and/or purification of the solution containing transcribed RNA by one or more tangential flow filtration (TFF) steps; where the procedure in step C) includes at least one diafiltration step using TFF; comprising at least one diafiltration step using TFF in step C) diafiltration with an aqueous salt solution; where the aqueous saline solution contains approximately 0,1 M alkali metal halide up to about 1 M alkali metal halide; where the procedure in step C) includes at least one further cleaning procedure before or after one or more TFF steps;where at least one further cleaning process is a reverse phase chromatography process; where the reverse phase chromatography process uses a stationary reverse phase and a mixture of an aqueous and an organic solvent as a mobile phase for the elution of the RNA; and comprising at least one or more TFF steps the use of a TFF membrane set.