METHODS FOR PROCESSING FLUID CONTAINING RECOMBINANT THERAPEUTIC PROTEIN AND THEIR APPLICATION Russian patent published in 2021 - IPC C07K1/34 C07K1/36 B01D61/14 B01D61/58 

FIELD: biotechnolgy.

SUBSTANCE: group of inventions relates to the field of biotechnology and concerns methods for filtering a fluid containing a recombinant protein to remove viruses. To do this, the fluid containing the recombinant protein is processed in a system that includes a first closed-loop system containing a tangential flow filtration unit (TFF) and a second closed-loop system containing a tangential flow virus filtration unit (TFVF). The first closed-loop system is designed in such a way that the fluid can flow through the pipeline and the TFF unit, and a filtrate that does not contain a recombinant therapeutic protein can be collected from the TFF unit. The second closed-loop system is designed so that the fluid can flow through the second pipeline and the TFVF unit, and the filtrate containing the recombinant therapeutic protein can be collected from the TFVF unit. In this case, the rate of recirculation of the retentate in the second closed-loop system and the rate of infusion of the collected fluid into the second closed-loop system are independently controlled. The group of inventions also relates to a variant of this method, in which the fluid is processed only in a closed-loop system containing a filter unit for viruses in a tangential flow (TFVF).

EFFECT: invention makes it possible to optimize the filtration method for extending the operation of a single filter to several days.

19 cl, 16 dwg, 3 ex