Methods of reducing the enzymatic hydrolysis activity rate in a composition obtained from a purification platform
AssigneesGenentech, Inc., Hoffmann-La Roche Inc.
InventorsMichael LEISS, Christian MEYER, Alexandra Thomas MORRIS, Bernhard SPENSBERGER, Yinges YIGZAW, Franziska EDELMANN, Roberto FALKENSTEIN, Tobias GRAF, Jie GU, Jeevan PRABHAKAR
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Abstract
The present disclosure provides purification platforms comprising a depth filter step and/or a hydrophobic interaction chromatography (HIC) step. Also disclosed herein are methods of using the purification platforms described herein and compositions obtained therefrom, such as pharmaceutical compositions.
Claims112
A method of reducing an enzymatic hydrolysis activity rate of a composition obtained from a purification platform, the method comprising subjecting a sample to the purification platform comprising:
- (a) a capture step;
- and
- (b) a depth filtration step,
- thereby reducing the enzymatic hydrolysis activity rate of the composition as compared to purification of the sample using the same purification platform without the depth filtration step.
A method of reducing the level of one or more hydrolytic enzymes in a composition obtained from a purification platform, the method comprising subjecting a sample to the purification platform comprising:
- (a) a capture step;
- and
- (b) a depth filtration step,
- thereby reducing the level of the hydrolytic enzyme in the composition as compared to purification of the sample using the same purification platform without the depth filtration step.
A method for reducing degradation of a polysorbate in a composition obtained from a purification platform, the method comprising subjecting a sample to the purification platform comprising:
- (a) a capture step;
- and
- (b) a depth filtration step,
- thereby reducing degradation of the polysorbate in the composition as compared to purification of the sample using the same purification platform without the depth filtration step.
A method of reducing an enzymatic hydrolysis activity rate of a composition obtained from a purification platform, the method comprising subjecting a sample to the purification platform comprising, in the following order:
- (a) a capture step comprising processing via affinity chromatography;
- (b) a virus inactivation step;
- (c) a second polypeptide purification step;
- (d) a third polypeptide purification step;
- and
- (e) a ultrafiltration/diafiltration (UFDF) step,
- wherein the purification platform further comprises a depth filtration step performed at one or more of the following:
- (i) prior to the capture step;
- (ii) after the capture step and prior to the virus inactivation step;
- (iii) after the virus inactivation step and prior to the second polypeptide purification step;
- (iv) after the second polypeptide purification step and prior to the third polypeptide purification step;
- or
- (v) after the third polypeptide purification step and prior to the ultrafiltration/diafiltration (UFDF) step;
- thereby reducing the enzymatic hydrolysis activity rate of the composition as compared to purification of the sample using the same purification platform without the depth filtration step.
A formulated antibody moiety composition comprising an antibody moiety and a polysorbate wherein the composition has a reduced polysorbate hydrolysis activity rate, wherein the shelf-life of the composition is more than 24 months.
A formulated antibody moiety composition comprising an antibody moiety and a polysorbate, wherein the composition has a reduced polysorbate hydrolysis activity rate, wherein the shelf-life of the composition is extended compared to the shelf-life indicated in documents filed with a health authority related to the formulated antibody moiety composition, wherein the shelf-life is extended by at least 6 months compared to the shelf-life indicated in said documents.
A formulated antibody moiety composition comprising an antibody moiety, wherein the formulated antibody moiety composition has a reduced degradation of polysorbate, wherein the degradation is reduced by at least about 20% compared to the degradation indicated in documents filed with a health authority related to the formulated antibody moiety composition.
A formulated antibody moiety composition comprising an antibody moiety and a polysorbate, wherein the polysorbate is degraded during storage of the liquid composition by 20% or less per year.
A method of reducing an enzymatic hydrolysis activity rate of a composition obtained from a purification platform, the method comprising subjecting a sample to the purification platform comprising, in order:
- (a) a capture step comprising processing via affinity chromatography;
- and
- (b) a purification step comprising processing via a chromatography selected from the group consisting of a HIC, a cation exchange chromatography, and a multimodal chromatography,
- wherein the purification platform further comprises one or more depth filtration steps,
- wherein the one or more depth filtration steps are performed at any one or more of:
- prior to the capture step;
- after the capture step;
- or after the capture step and prior to the purification step,
- wherein each depth filtration step comprises processing via a depth filter, and
- wherein the depth filter comprises materials selected from the group consisting of:
- (i) a silica and a polyacrylic fiber;
- (ii) a hydrogel Q (quaternary amine)-functionalized non-woven media and a multi-zone microporous membrane;
- and
- (iii) cellulose fibers, diatomaceous earth, and perlite,
- thereby reducing the enzymatic hydrolysis activity rate of the composition as compared to purification of the sample using the same purification platform without the one or more depth filtration steps.
A method of reducing the level of one or more hydrolytic enzymes in a composition obtained from a purification platform, the method comprising subjecting a sample to the purification platform comprising, in order:
- (a) a capture step comprising processing via affinity chromatography;
- and
- (b) a purification step comprising processing via a chromatography selected from the group consisting of a HIC, a cation exchange chromatography, and a multimodal chromatography,
- wherein the purification platform further comprises one or more depth filtration steps,
- wherein the one or more depth filtration steps are performed at any one or more of:
- prior to the capture step;
- after the capture step and prior to the purification step;
- or after the purification step,
- wherein each depth filtration step comprises processing via a depth filter, and
- wherein the depth filter comprises materials selected from the group consisting of:
- (i) a silica and a polyacrylic fiber;
- (ii) a hydrogel Q (quaternary amine)-functionalized non-woven media and a multi-zone microporous membrane;
- and
- (iii) cellulose fibers, diatomaceous earth, and perlite,
- thereby reducing the level of one or more hydrolytic enzymes in the composition as compared to purification of the sample using the same purification platform without the one or more depth filtration steps.
A method of reducing degradation of a polysorbate in a composition obtained from a purification platform, the method comprising subjecting a sample to the purification platform comprising, in order:
- (a) a capture step comprising processing via affinity chromatography;
- and
- (b) a purification step comprising processing via a chromatography selected from the group consisting of a HIC, a cation exchange chromatography, and a multimodal chromatography,
- wherein the purification platform further comprises one or more depth filtration steps,
- wherein the one or more depth filtration steps are performed at any one or more of:
- prior to the capture step;
- after the capture step;
- or after the capture step and prior to the purification step,
- wherein each depth filtration step comprises processing via a depth filter, and
- wherein the depth filter comprises materials selected from the group consisting of:
- (i) a silica and a polyacrylic fiber;
- (ii) a hydrogel Q (quaternary amine)-functionalized non-woven media and a multi-zone microporous membrane;
- and
- (iii) cellulose fibers, diatomaceous earth, and perlite,
- thereby reducing degradation of a polysorbate in the composition as compared to purification of the sample using the same purification platform without the one or more depth filtration steps.
Dependencies are inferred from the claim text.