PROCESSES FOR SEPARATING AGGREGATED PROTEINS FROM MONOMERIC PROTEINS IN A BIOLOGICAL SOLUTION
A process for separating aggregated proteins from monomeric proteins in a biological solution, the process including: providing at least one filter element having a contacting surface, wherein the filter element comprises filter media comprising: a porous substrate; and disposed on the porous substrate, a polymer comprising a hydrocarbon backbone and a plurality of pendant groups attached to the hydrocarbon backbone, wherein each of a first plurality of pendant groups comprises: (1) at least one acidic group or salt thereof; and (2) a spacer group that directly links the at least one acidic group or salt thereof to the hydrocarbon backbone by a chain of at least 6 catenated atoms; and allowing an initial biological solution to contact the contacting surface of the filter element N under conditions effective to separate the aggregated proteins from the monomeric proteins such that a final biological solution includes purified monomeric proteins.
1 . A process for separating aggregated proteins from monomeric proteins in a biological solution, the process comprising:
providing at least one filter element having a contacting surface, wherein the filter element comprises filter media comprising:
a porous substrate; and
disposed on the porous substrate, a polymer comprising a hydrocarbon backbone and a plurality of pendant groups attached to the hydrocarbon backbone, wherein each of a first plurality of pendant groups comprises:
(1) at least one acidic group or salt thereof; and
(2) a spacer group that directly links the at least one acidic group or salt thereof to the hydrocarbon backbone by a chain of at least 6 catenated atoms; and
allowing an initial biological solution to contact the contacting surface of the filter element under conditions effective to separate the aggregated proteins from the monomeric proteins such that a final biological solution includes purified monomeric proteins.
2 . The process of claim 1 wherein the polymer comprises interpolymerized units of at least one monomer comprising:
(1) at least one ethylenically unsaturated group;
(2) at least one acidic group or salt thereof; and
(3) a spacer group that directly links the at least one ethylenically unsaturated group and the at least one acidic group or salt thereof by a chain of at least 6 catenated atoms.
3 . The process of claim 1 further comprising recovering the monomeric proteins without eluting.
4 . The process of claim 1 wherein the conditions are effective to recover, in the final solution, at least 70% of the monomeric proteins present in the initial biological solution.
5 . The process of claim 1 wherein the conditions are effective to remove at least 10% of the aggregated proteins from the initial biological solution.
6 . The process of claim 1 wherein the proteins comprise antibodies, enzymes, or hormones.
7 . The process of claim 6 wherein the proteins comprise antibodies.
8 . The process of claim 1 wherein the conditions comprise a pH of the biological solution of below 9.
9 . The process of claim 1 wherein the conditions comprise a conductivity of the biological solution of at least 1 mS/cm.
10 . The process of claim 1 wherein the at least one acidic group or salt thereof of the polymer disposed on the porous substrate is present at a density of at least 0.02 mmole/gram of filter media.
11 . The process of claim 2 wherein the at least one ethylenically unsaturated group is selected from an ethenyl group, a 1-alkylethenyl group, and a combination thereof.
12 . The process of claim 1 wherein the chain of the spacer group has at least 8 catenated atoms.
13 . The process of claim 1 wherein the at least one acidic group or salt thereof is selected from a carboxy group, a phosphono group, a phosphato group, a sulfono group, a sulfato group, a boronato group, and a combination thereof.
14 . The process of claim 1 wherein the spacer group is a catenated heteroatom-containing hydrocarbon group.
15 . The process of claim 1 wherein the spacer group comprises at least one hydrogen bonding moiety.