Fc FUSION HIGH AFFINITY IgE RECEPTOR ALPHA-CHAIN

a high affinity, ige receptor technology, applied in the direction of immunoglobulins, peptides/protein ingredients, peptides against animals/humans, etc., can solve the problems of reduced purification efficiency or production amount in the production of protein pharmaceutical products, poor stability of proteins at low ph, and high cost, and achieve excellent stability and neutralizing activity against ige

Inactive Publication Date: 2018-11-01
KISSEI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The protein described in this patent is stable at low pH and can neutralize a specific protein (IgE) associated with allergic diseases. This makes it a promising choice for creating medicine to treat such illnesses.

Problems solved by technology

On the other hand, it may cause a problem specific to the protein pharmaceutical product in the production process thereof.
A protein, which is poor in stability at low pH, easily forms aggregates.
If the ratio of aggregates is high, a reduction in purification efficiency or production amount occurs in the production of protein pharmaceutical products.
In addition, an immune response is provoked by mixing aggregates into pharmaceutical products, and as a result, serious side effects, such as anaphylaxis, are likely to occur.
As such, the instability of a protein of interest at low pH may be problematic in the production of protein pharmaceutical products.
However, this publication does not specifically describe a fused protein of a high affinity IgE receptor and an immunoglobulin.

Method used

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  • Fc FUSION HIGH AFFINITY IgE RECEPTOR ALPHA-CHAIN

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example 1

Expression and Preparation of Protein 1

(1) Preparation of Protein 1 Expression Vector

[0068]cDNA encoding the amino acid sequence shown in SEQ ID NO: 3 was incorporated into a mammalian expression plasmid vector to prepare a Protein 1 expression plasmid.

(2) Preparation of Protein 1-Expressing Cells

[0069]The Protein 1 expression plasmid was introduced into Chinese hamster ovary cells (CHO) to establish a Protein 1 stable expression cell line. Secretion of Protein 1 into a culture supernatant was confirmed by SDS-PAGE.

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Abstract

Provided is an Fc fusion high affinity IgE receptor α-chain having excellent stability at low pH. An Fc fusion protein comprising:(i) a high affinity IgE receptor α-chain; and(ii) an Fc region of IgG1, whereina linker fragment region between the (i) and the (ii) is the amino acid sequence shown in SEQ ID NO: 2.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a Continuation of U.S. application Ser. No. 15 / 552,065, which is a National Stage application of PCT / JP2016 / 054854, filed Feb. 19, 2016, which claims priority from Japanese application nos. JP 2015-032231, filed Feb. 20, 2015, and JP 2015-252231, filed Dec. 24, 2015.[0002]The instant application contains a Sequence Listing which has been submitted in ASCII format via EFS-WEB and is hereby incorporated by reference in its entirety. Said ASCII copy, created on Jul. 10, 2018, is named sequence.txt and is 10 KB.TECHNICAL FIELD[0003]The present invention relates to an Fc fusion high affinity IgE receptor α-chain that is useful as a pharmaceutical product.[0004]More specifically, the present invention relates to an Fc fusion high affinity IgE receptor α-chain having excellent stability at low pH, and a medicinal use thereof.BACKGROUND ART[0005]Immunoglobulin E (IgE) is one of an immunoglobulin group, which plays a role in al...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C07K14/735C12N15/09A61K38/16C07K16/18C07K14/705C07K19/00
CPCC07K2319/30C07K14/70535C12N15/09A61K38/16C07K16/18C07K14/705C07K19/00A61K38/00A61K47/68
Inventor SAKAMOTO, TAKASHIINADA, YOICHIYOKOYAMA, KAZUMASA
Owner KISSEI PHARMA
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