Methods, apparatuses, and systems for continuously inactivating a virus during manufacture of a biological product
US-11725191-B2 · Aug 15, 2023 · US
US12435303B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-12435303-B2 |
| Application number | US-201917283281-A |
| Country | US |
| Kind code | B2 |
| Filing date | Oct 7, 2019 |
| Priority date | Oct 8, 2018 |
| Publication date | Oct 7, 2025 |
| Grant date | Oct 7, 2025 |
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A viral inactivation device including at least one continuous viral inactivation reactor having an inlet, an outlet, and a tubular flow path. The tubular flow path includes a set of alternating turns that form a serpentine pattern between the inlet and the outlet.
Opening claim text (preview).
We claim: 1. A viral inactivation device comprising: at least one continuous viral inactivation reactor including an inlet, an outlet, and a tubular flow path comprising a set of alternating turns that form a serpentine pattern between the inlet and the outlet; wherein the tubular flow path includes a diameter of from 0.6 cm to 0.7 cm; and wherein the set of alternating turns are segmented vertically into at least two stacked layers, wherein each of the at least two stacked layers include a thickness of from 0.7 cm to 1.2 cm. 2. The device of claim 1 , wherein the at least one continuous viral inactivation reactor is an in-line tubular continuous viral inactivation reactor. 3. The device of claim 1 , wherein the set of alternating turns comprises at least two alternating turns having an angle of from 270° to 280°. 4. The device of claim 1 , wherein the set of alternating turns comprises from 2 to 325 or more alternating turns having an angle of from 270° to 280°. 5. The device of claim 1 , wherein each of the at least two stacked layers comprises 12.5 alternating turns in a single plane, wherein each of the alternating turns includes an angle of from 270° to 280°. 6. The device of claim 1 , wherein each of the at least two stacked layers is connected to one another via a 180° turn of the tubular flow path. 7. The device of claim 6 , wherein the at least two stacked layers are 26 layers connected to one another via 25 180° turns of the tubular flow path. 8. The device of claim 1 , wherein the at least one continuous viral inactivation reactor comprises from 2 to 6 viral inactivation reactors connected in series. 9. The device of claim 1 , wherein the set of alternating turns is arranged to generate a vortex to induce mixing a product stream having a laminar flow with a Reynolds Number of from 187.7 to 375.5. 10. The device of claim 1 , wherein the tubular flow path includes dimensions such that a product stream is in the continuous viral inactivation reactor for at least 30 minutes.
Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) · CPC title
Purification (C12M47/04 takes precedence) · CPC title
Means for mixing, agitating or circulating fluids in the vessel (by introduction of gas C12M29/06, C12M29/14, mixing in general or mixers per se B01F; mixing in apparatus for chemical or physical processes B01J) · CPC title
Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass (filters in general B01D24/00 - B01D41/00) · CPC title
Tubular (C12M23/08, C12M23/16 take precedence) · CPC title
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