Process of purification of protein

{
  "publication_number": "US2026103542A1",
  "country": "US",
  "kind": "A1",
  "title": "Process of purification of protein",
  "abstract": "A process for purification of antibody or fusion protein through anion exchange chromatography to produce an antibody or fusion protein which is substantially free of at least one of the product-related impurities.",
  "claims": [
    "1. A composition comprising omalizumab and product related impurities selected from the group comprising of acidic variants (AV), and high molecular weight (HMW) species; wherein the composition comprising: (a) an average ratio of acidic variants to the main peak of the omalizumab of about 0.16±0.06; and/or (b) an average ratio of HMW species to the monomer (main peak) of the omalizumab of below about 0.0500; wherein, the average ratio is determined from five production batches of omalizumab produced at a 500 L batch scale; wherein, the composition is reproducible; wherein, the composition maintains consistency in the average ratios; and; wherein the average ratio in (a) is measured by CE-HPLC; wherein the average ratio in (b) is measured by SE-HPLC. 2. The composition as claimed in claim 1, wherein the average ratio of acidic variants to main peak is about 0.16±0.05. 3. The composition as claimed in claim 1, wherein the average ratio of acidic variants to main peak is about 0.16±0.04. 4. The composition as claimed in claim 1, wherein the average ratio of acidic variants to main peak is about 0.16±0.03. 5. The composition as claimed in claim 1, wherein the average ratio of acidic variants to main peak is about 0.14±0.01. 6. The composition as claimed in claim 1, wherein the average ratio of HMW species to monomer (main peak) is below about 0.0400. 7. The composition as claimed in claim 1, wherein the average ratio of HMW species to monomer (main peak) is below about 0.0300. 8. The composition as claimed in claim 1, wherein the average ratio of HMW species to monomer (main peak) is below about 0.0100. 9. The composition as claimed in claim 1, wherein the average ratio of HMW species to monomer (main peak) is below about 0.0050. 10. The composition as claimed in claim 1, wherein the main peak of the omalizumab has purity of at least about 90% and HMW of below about 5% as analysed by SE-HPLC. 11. The composition as claimed in claim 1, wherein the main peak of the omalizumab has purity of at least about 95% and HMW of below about 3% as analysed by SE-HPLC. 12. The composition as claimed in claim 1, wherein the main peak of the omalizumab has purity of at least about 98% and HMW of below about 1% as analysed by SE-HPLC. 13. The composition as claimed in claim 1, wherein the main peak of the omalizumab has purity of at least about 98% and HMW of below about 0.5% as analysed by SE-HPLC. 14. The composition as claimed in claim 1, wherein the main peak of the omalizumab has purity of at least about 70% and acidic variants of below about 16% as analysed by CE-HPLC. 15. The composition as claimed in claim 1, wherein the main peak of the omalizumab has purity of at least about 72% and acidic variants of below about 15% as analysed by CE-HPLC. 16. The composition as claimed in claim 1, wherein the main peak of the omalizumab has purity of at least about 75% and acidic variants of below about 13% as analysed by CE-HPLC. 17. The composition as claimed in claim 1, wherein the main peak of the omalizumab has purity of at least about 76% and acidic variants of below about 12% as analysed by CE-HPLC. 18. A composition comprising omalizumab and a product related impurities selected from the group comprising of acidic variants (AV), and high molecular weight (HMW) species; wherein the composition comprising: (a) an average ratio of acidic variants to the main peak of the omalizumab of about 0.14±0.01; and/or (b) an average ratio of HMW species to the monomer (main peak) of the omalizumab of below about 0.0050; wherein, the average ratio is determined from five production batches of omalizumab produced at a 500 L batch scale; wherein, the composition is reproducible; wherein, the composition maintains consistency in the average ratios; and; wherein the average ratio in (a) is measured by CE-HPLC; wherein the average ratio in (b) is measured by SE-HPLC. 19. The composition as claimed in claim 18, wherein the average ratio is reproducible in at least five batches; and wherein the composition maintains consistency in the average ratios across the five batches. 20. The composition as claimed in claim 1, wherein the composition is produced by a process performed at large scale; wherein the process comprises: a) culturing the cell capable to express omalizumab; b) harvesting the culture; c) purifying the harvested cell culture; wherein the purification comprises affinity chromatography; wherein the large scale is 500 L batch scale; wherein the process is reproducible; wherein the process provides consistency in maintaining the average ratios of acidic variants to main peak and HMW to main peak; wherein the average ratio is derived from at least 5 batches of 500 L scale. 21. The composition as claimed in claim 19, wherein the purification further comprises low pH viral inactivation followed by neutralization and filtration. 22. The composition as claimed in claim 19, wherein affinity chromatography is Protein A chromatography. 23. The composition as claimed in claim 18, Wherein the composition is produced by a process performed at large scale; wherein the process comprises: a) culturing the cell capable to express omalizumab; b) harvesting the culture; c) purifying the harvested cell culture; wherein the purification comprises: i. affinity chromatography; ii. low pH viral inactivation and neutralization; iii. filtration; iv. Anion exchange chromatography; Wherein the large scale is 500 L batch scale; Wherein the process is reproducible; Wherein the process provides consistency in maintaining: i. the average ratios of acidic variants to main peak; and ii. the average ratio of high molecular weight species to main peak; Wherein the average ratios are derived from at least 5 batches of 500 L scale. 24. The composition as claimed in claim 21, wherein the anion exchange is strong anion exchange. 25. The composition as claimed in claim 22, wherein the anion exchange is POROS 50 HQ."
  ],
  "cpc": [
    "C07K 16/4291",
    "C07K 1/18",
    "C07K 1/22",
    "C07K 1/34",
    "C07K 2317/24"
  ],
  "filing_date": "2025-05-27",
  "publication_date": "2026-04-16",
  "priority_date": "2020-05-01",
  "application_number": "US-202519219429-A"
}