Process of purification of protein
AssigneeKashiv Biosciences, LLC
InventorsOm Narayan, Tarun Kumar Gupta, Mayankkumar Thakkar
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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.
Claims15
A pharmaceutical composition comprising biosimilar of 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 biosimilar of omalizumab of at least 90% purity.
Dependencies are inferred from the claim text.