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US 12,760,062 B2Granted
Process of storing and preparing the protein
AssigneeKashiv Biosciences, LLC
InventorsOm Narayan, Tarun Kumar Gupta, Mayankkumar Thakkar, Kishor Galani
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Abstract
The present invention provides a method for reducing the protein aggregation by adjusting the pH below 6.0 of liquid formulation comprising the antibody or fusion protein. The present invention also provides methods for storing the pre-formulation for longer period without using any sugar or additives which can be utilized for preparation of liquid or lyophilized formulation.
Claims22
A process for the preparation of a stable formulation comprising:
- (a) a pre-formulation capable to formulate in a lyophilized or a liquid formulation comprising:
- (i) an antibody of interest,
- (ii) a buffer,
- (iii) a pH;
- (b) adjusting the pH of the pre-formulation to about pH 5.0 to about 5.9;
- (c) optionally performing ultrafiltration;
- (d) storing the pre-formulation at a freezing temperature for a period of time;
- (e) performing a freeze thaw cycle of the pre-formulation;
- (f) mixing suitable excipients in the pre-formulation to formulate a final formulation;
- wherein the pre-formulation comprises low aggregates or high molecular weight impurities after storing at the freezing temperature.
7 more elements
Dependencies are inferred from the claim text.