In-vitro method for determining fate of polypeptide variant
AssigneeDr. Reddy's Laboratories, Inc.
InventorsRajesh MEDISETTY, Lella RAVI KUMAR, Sridevi KHAMBHAMPATY
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Abstract
The present invention discloses an in-vitro method for determining the fate of protein variants upon administration to a subject. Also provided is a means for establishing comparability between two or more distinct therapeutically effective preparations of the same therapeutic protein.
Claims5
A Method of determining polypeptide variants of a polypeptide preparation administered to a subject, comprising;
- a) isolating serum or plasma from a subject
- b) depleting immunoglobulin from the said serum or plasma,
- c) spiking the immunoglobulin depleted serum or plasma with the therapeutically effective polypeptide preparation
- d) incubating the spiked serum or plasma of step c for a period of time
- e) isolating the polypeptide and variants thereof from the spiked serum or plasma of step d, and
- f) quantifying the polypeptide and polypeptide variants isolated in step e.
2). The polypeptide preparation as in claim 1, is a therapeutic polypeptide preparation.
3). The therapeutic polypeptide preparation as in claim 2, includes immunoglobulin and non-immunoglobulin preparation.
4). The polypeptide variants as in claim 1, are selected from the variants group consisting of charge variants and glycovariants
5). An in-vitro method for demonstration of clinical significance of a polypeptide variant of administered polypeptide variants, comprising;
- a) Isolating serum or plasma from a subject
- b) depleting immunoglobulin from the said serum or plasma
- c) spiking the immunoglobulin depleted serum or plasma with the therapeutically effective polypeptide preparation
- d) incubating the spiked serum or plasma of step c for a period of time
- e) isolating the polypeptide and variants thereof from the spiked serum or plasma of step d, and
- f) quantifying the polypeptide and polypeptide variants isolated in step e.
Dependencies are inferred from the claim text.