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.
Claims18
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 filter aid and a polyacrylic fiber pulp;
- and
- (ii) cellulose fibers, diatomaceous earth, and perlite,
- wherein the depth filter comprising the cellulose fibers, diatomaceous earth, and perlite comprises two layers, wherein each layer comprises a cellular filter matrix impregnated with a filter aid comprising one or more of diatomaceous earth or perlite, and wherein each layer further comprises a resin binder,
- 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.
Dependencies are inferred from the claim text.