Deamidated interferon-beta
OwnerKenji Furuya, Deborah Johnson-Jackson +1inventors
InventorsKENJI FURUYA, DEBORAH JOHNSON-JACKSON, DIANA TIERRA RUSCIO
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Abstract
Interferon-β protein analogs in which the asparagine at position 25, numbered in accordance with native interferon-β, is deamidated exhibit a biological activity of native human interferon-β at an increased level and do not require HA for protein stabilization. The deamidated product is suitable for large scale manufacturing for incorporation in HA-containing or HA-free therapeutics for treatment of diseases including multiple sclerosis. An endoproteinase-C peptide map technique that produces a fingerprint profile for proteins using an enzymatic digest followed by RP-HPLC is also useful in quality control as an ID and/or quantitative test for the deamidated products.
Claims28
A purified and isolated synthetic human interferon-β protein analog, wherein,
- the asparagine at position 25, numbered in accordance with native interferon-β, is deamidated, and,
- said protein analog exhibits a biological activity of native human interferon-β.
A method of making deamidated INF-β analog, comprising:
- incubating an IFN-β protein under conditions suitable at moderate to high temperature of about 25-60° C.;
- purifying and isolating the deamidated protein analog.
A peptide mapping method, comprising:
- incubating a protein sample in a buffered solution below pH 8 containing a reducing agent;
- digesting the incubated sample with endoproteinase-C;
- and
- resolving the peptide fragments of the digest by liquid chromatography.
Dependencies are inferred from the claim text.