# US 12,600,747 B2 · Process of purification of protein > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,600,747 B2 - Document ID: US12600747B2 - Status: Granted - Kind: B2 - Application number: 19/092,641 - Filed: 2025-03-27 - Published: 2025-09-11 - Granted: 2026-04-14 - Earliest claimed: 2020-05-01 - Assignees: Kashiv Biosciences, LLC - Applicants: Kashiv BioSciences, LLC - Inventors: Om Narayan; Tarun Kumar Gupta; Mayankkumar Thakkar - Web page: https://patentgrep.com/patent/US12600747B2 ## CPC - C07K 1/16: by chromatography - C07K 16/065: {Purification, fragmentation} - C07K 16/4291: {against IgE} - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) ## Abstract The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities. ## Claims ### Claim 1 A pharmaceutical composition comprising omalizumab and an acidic species or variant thereof, wherein the pharmaceutical composition comprises the acidic species or variant thereof in an amount of 11% or less as measured by cation exchange high performance liquid chromatography analysis; and wherein the pharmaceutical composition has omalizumab purity of at least 90%. ### Claim 2 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition has omalizumab purity of more than 90%. ### Claim 3 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition has omalizumab purity of more than 95%. ### Claim 4 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition has omalizumab purity of more than 96%. ### Claim 5 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition has omalizumab purity of more than 97%. ### Claim 6 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition has omalizumab purity of more than 98%. ### Claim 7 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition has omalizumab purity of more than 99%. ### Claim 8 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition comprises the acidic species or variant thereof in an amount of 10% or less as measured by cation exchange high performance liquid chromatography analysis. ### Claim 9 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition has omalizumab purity of at least 90% as measured by size exclusion high performance liquid chromatography. ### Claim 10 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition is prepared at 50 L scale. ### Claim 11 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition is prepared at 200 L scale. ### Claim 12 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition comprises the acidic species or variant thereof in an amount of 9% or less as measured by cation exchange high performance liquid chromatography analysis. ### Claim 13 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition comprises the acidic species or variant thereof in an amount of 8.5% or less as measured by cation exchange high performance liquid chromatography analysis. ### Claim 14 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition comprises the acidic species or variant thereof in an amount of 8% or less as measured by cation exchange high performance liquid chromatography analysis. ### Claim 15 (depends on 1) The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition maintains omalizumab quality at scale of 5 L, 50 L, and 200 L.