Granted Patent
B2
US 12,378,282 · App. 18/893,058 · Granted Aug 5, 2025
Process of purification of protein
Inventors:
Om Narayan (Ahmedabad, IN); Tarun Kumar Gupta (Ahmedabad, IN); Mayankkumar Thakkar (Ahmedabad, IN)
Assignee:
Kashiv BioSciences, LLC
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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 (8)
1. A pharmaceutical composition comprising omalizumab and one or more low molecular weight (LMW) variants selected from LC, HC, HH, and 2H1L, wherein one or more low molecular weight (LMW) variants are present in an amount of about 3% of total amount of the one or more LMW variants, as analyzed by CE-SDS; and wherein the pharmaceutical composition has omalizumab purity of at least 90%.
2. The pharmaceutical composition according to claim 1 , wherein one or more low molecular weight (LMW) variants are present in an amount of about 2.6% of total amount of the one or more LMW variants, as analyzed by CE-SDS.
3. The pharmaceutical composition according to claim 2 , wherein one or more low molecular weight (LMW) variants are present in an amount of about 2.3% or less of total amount of the one or more LMW variants, as analyzed by CE-SDS.
4. The pharmaceutical composition of claim 1 , wherein the omalizumab purity is more than 99% as measured by size exclusion high performance liquid chromatography (SE-HPLC).
5. The pharmaceutical composition of claim 1 , wherein the omalizumab purity is more than 70% as measured by CEX-HPLC.
6. A pharmaceutical composition comprising omalizumab and one or more low molecular weight (LMW) variants selected from LC, HC, HH, and 2H1L, wherein when the pharmaceutical composition comprises LC, the LC is present in an amount of about 0.5% or less of total amount of the one or more LMW variants, as analyzed by CE-SDS; wherein when the pharmaceutical composition comprises HH, the HH is present in an amount of about 0.2% or less of total amount of the one or more LMW variants, as analyzed by CE-SDS; wherein when the pharmaceutical composition comprises HC, the HC is present in an amount of about 0.4% or less of total amount of the one or more LMW variants, as analyzed by CE-SDS; wherein when the pharmaceutical composition comprises 2H1L, the 2H1L is present in an amount of about 3% or less of total amount of the one or more LMW variants, as analyzed by CE-SDS; and wherein the pharmaceutical composition has omalizumab purity of at least 90%.
7. The pharmaceutical composition of claim 6 , wherein the omalizumab purity is more than 92% as measured by size exclusion high performance liquid chromatography (SE-HPLC).
8. The pharmaceutical composition of claim 7 , wherein the omalizumab purity is more than 95% as measured by size exclusion high performance liquid chromatography (SE-HPLC).
Assignments (3)
SHORT FORM TERM LOAN INTELLECTUAL PROPERTY SECURITY AGREEMENT
Recorded Jul 3, 2025
From: KASHIV BIOSCIENCES, LLC
To: ACQUIOM AGENCY SERVICES, AS COLLATERAL AGENT
Reel/Frame 071824/0222 →
SHORT FORM TERM LOAN INTELLECTUAL PROPERTY ASSIGNMENT
Recorded May 1, 2025
From: KASHIV BIOSCIENCES, LLC
To: ACQUIOM AGENCY SERVICES LLC, AS COLLATERAL AGENT
Reel/Frame 071150/0372 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 28, 2025
From: NARAYAN, OM; GUPTA, TARUN KUMAR; THAKKAR, MAYANKKUMAR
To: KASHIV BIOSCIENCES, LLC
Reel/Frame 070038/0987 →
Priority Claims (3)
IN 202021018714
· May 1, 2020
· national
IN 202021018731
· May 1, 2020
· national
IN 202021018735
· May 1, 2020
· national
Continuity (3)
Continuation
17922729
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