Alternate detergents for viral inactivation
AssigneeAmgen Inc.
InventorsGabriella Perell, Rosa Daneshvar, Martina Kopp
Life of this patent
Estimating the term…
Abstract
Detergents for use to inactivate enveloped viruses, including detergents that are considered eco-friendly that can be used in biomanufacturing operations.
Claims55
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 from Table 1;
- at a concentration and for a time sufficient to cause viral inactivation.
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 3055-98-9, CAS 9043-30-5, CAS 85618-20-8, 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 69227-93-6, CAS 82494-09-5, CAS 253678-67-0, CAS 106402-05-5, or CAS 93911-12-7 at a concentration and for a time sufficient 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.
A method for producing an isolated, purified, recombinant protein of interest comprising
- establishing a cell culture in a bioreactor with a host cell expressing a recombinant protein and culturing the cells to express the recombinant protein of interest;
- harvesting cell culture fluid containing the recombinant protein of interest;
- subjecting the harvested fluid containing the recombinant protein of interest to a detergent having a CAS registry number of CAS 3055-99-0, CAS 3055-98-9, CAS 9043-30-5, CAS 85618-20-8, 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 69227-93-6, CAS 82494-09-5, CAS 253678-67-0, CAS 106402-05-5, or CAS 93911-12-7, at a detergent concentration and for a time sufficient to cause inactivation of enveloped virus;
- processing the viral inactivated fluid containing the recombinant protein of interest through at least two additional unit operations;
- and
- obtaining an isolated, purified, recombinant protein of interest.
A method for producing an isolated, purified, recombinant protein of interest comprising establishing a cell culture in a bioreactor with a host cell expressing a recombinant protein and culturing the cells to express the recombinant protein of interest;
- harvesting cell culture fluid containing the recombinant protein of interest;
- processing the fluid containing the recombinant protein of interest through at least two unit operations, wherein during at least one unit operation there is a step where the fluid containing the recombinant protein of interest is combined with a detergent having a CAS registry number of CAS 3055-99-0, CAS 3055-98-9, CAS 9043-30-5, CAS 85618-20-8, 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 69227-93-6, CAS 82494-09-5, CAS 253678-67-0, CAS 106402-05-5, or CAS 93911-12-7, at a detergent concentration and for a time sufficient to cause inactivation of enveloped virus;
- and
- obtaining an isolated, purified, recombinant protein of interest.
Dependencies are inferred from the claim text.