Alternate detergents for viral inactivation
Detergents for use to inactivate enveloped viruses, including detergents that are considered eco-friendly that can be used in biomanufacturing operations.
1 . A method for inactivating envelope virus in a fluid known or suspected to contain at least one enveloped virus, comprising
obtaining a fluid known or suspected to contain at least one enveloped virus;
exposing the fluid to a detergent having a CAS registry number of CAS 3055-99-0, CAS 9043-30-5, CAS 181135-58-0, CAS 181135-57-9, CAS 250692-65-0, CAS 228579-27-9, CAS 349477-49-2, CAS 70504-28-8, CAS 59080-45-4, CAS 69984-73-2, CAS 148616-91-5, CAS 148565-55-3, CAS 82494-09-5, CAS 253678-67-0, CAS 106402-05-5, or CAS 93911-12-7;
at a detergent concentration that is 2.5× to 10× of its Critical Micelle Concentration (CMC) and time sufficient to cause viral inactivation.
2 . The method according to claim 1 wherein the fluid is exposed to the detergent for at least 30 seconds to at least 60 minutes or longer.
3 . The method according to claim 2 wherein the fluid is exposed to the detergent for at least 10 minutes.
4 . The method according to claim 1 , wherein the detergent concentration is at least 5× of its CMC.
5 . The method according to claim 1 , wherein exposure of the fluid to the detergent occurs at a temperature of at least 5° C. to 22° C.
6 . The method according to claim 5 , wherein exposure of the fluid to the detergent occurs at a temperature of at least 15° C.
7 . The method according to claim 1 , wherein the detergent concentration is 5× of its CMC and the time is at least 10 minutes.
8 . The method according to claim 1 , wherein the fluid comprises a recombinant protein of interest.
9 . The method according to claim 1 , wherein the fluid is harvested host cell culture fluid.
10 . The method according to claim 1 , wherein the fluid is from an effluent stream, eluate, pool, storage or hold from a unit operation comprising a harvest step, a filtration step or a chromatography step.
11 . The method according to claim 10 , wherein the fluid is
(i) eluate collected from depth filtration, microfiltration, affinity chromatography, ion exchange chromatography, multimodal chromatography, hydrophobic interaction chromatography or hydroxyapatite chromatography; or
(ii) a pool containing harvested cell culture fluid, eluate from depth filtration, eluate from microfiltration, eluate from affinity chromatography, eluate from ion exchange chromatography, eluate from multimodal chromatography, eluate from hydrophobic interaction chromatography, or eluate from hydroxyapatite chromatography.
12 . The method according to claim 11 , wherein the affinity chromatography is Protein A, Protein G, Protein A/G, or Protein L chromatography.
13 . A method for inactivating enveloped viruses during purification of a recombinant protein of interest comprising
obtaining a fluid comprising the recombinant protein of interest which is known or suspected to contain at least one virus;
subjecting the fluid to at least one detergent, wherein the detergent has a CAS registry number of CAS 3055-99-0, CAS 9043-30-5, CAS 181135-58-0, CAS 181135-57-9, CAS 250692-65-0, CAS 228579-27-9, CAS 349477-49-2, CAS 70504-28-8, CAS 59080-45-4, CAS 69984-73-2, CAS 148616-91-5, CAS 148565-55-3, CAS 82494-09-5, CAS 253678-67-0, CAS 106402-05-5, or CAS 93911 12-7 at a detergent concentration that is 5× of its Critical Micelle Concentration (CMC) and for at least 10 minutes to cause inactivation of enveloped viruses in the fluid; and
subjecting the viral inactivated fluid to at least one unit operation which includes at least a filtration step or a chromatography step.
14 . The method according to claim 13 , wherein the chromatography is selected from affinity chromatography, Protein A chromatography, ion exchange chromatography, anion exchange chromatography, cation exchange chromatography; hydrophobic interaction chromatography; mixed modal or multimodal chromatography, or hydroxyapatite chromatography.
15 . The method according to claim 13 , wherein:
(i) the fluid is harvested host cell culture fluid and the unit operation includes depth filtration;
(ii) the fluid is harvested host cell culture fluid and the unit operation includes microfiltration;
(iii) the fluid is harvested host cell culture fluid and the unit operation includes Protein A affinity chromatography; or
(iv) the fluid is Protein A eluant and the unit operation includes depth filtration.
16 . The method according to claim 13 , wherein the unit operation includes depth filtration or microfiltration.
17 . The method of claim 1 , wherein the detergent has a CAS registry number of CAS 3055-99-0 or CAS 9043-30-5.
18 . The method of claim 13 , wherein the detergent has a CAS registry number of CAS 3055-99-0 or CAS 9043-30-5.
19 . The method of claim 17 , wherein the detergent has a CAS registry number of CAS 3055-99-0.
20 . The method of claim 17 , wherein the detergent has a CAS registry number of CAS 9043-30-5.
21 . The method of claim 18 , wherein the detergent has a CAS registry number of CAS 3055-99-0.
22 . The method of claim 18 , wherein the detergent has a CAS registry number of CAS 9043-30-5.
23 . A method for inactivating envelope virus in a fluid known or suspected to contain at least one enveloped virus, comprising
obtaining a fluid known or suspected to contain at least one enveloped virus;
exposing the fluid to a detergent which is TDA-9, at a detergent concentration that is 2.5X to 10X of its Critical Micelle Concentration (CMC) and time sufficient to cause viral inactivation.