Human recombinant hyposialic acid-added erythropoietin, its purification method, and treatment applications.

A novel production process for rhEPO isoforms with a specific glycosylation pattern enhances neuroprotective and neurorepair efficacy by combining stirred tank fermentation and chromatography, addressing the limitations of existing rhEPO formulations.

JP7883949B2Active Publication Date: 2026-07-02CENT DE INMUNOLOGIA MOLECULAR CENT DE INMUNOLO
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Patent Information

Application Number
JP2022514643
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2019-09-05
Filing Date
2020-02-19
Publication Date
2026-07-02
Estimated Expiration
2040-02-19

AI Technical Summary

Technical Problem

Existing recombinant human erythropoietin (rhEPO) formulations, such as AsialoEPO and CEPO, suffer from limited neuroprotective effects due to short plasma half-life and adverse hematopoietic effects, while NeuroEPO formulations face challenges in achieving consistent neuroprotective efficacy in clinical trials.

Method used

A production process combining stirred tank fermentation and chromatography using an integrated column with a quaternary ammonium ligand to produce rhEPO isoforms with a specific isoelectric point range of 4.25 to 5.85, featuring a unique glycosylation pattern with mono- to tetrasialic acid residues, enhancing neuroprotective and neurorepair mechanisms.

Benefits of technology

The resulting rhEPO isoforms exhibit higher efficacy in both in vitro and in vivo neuroprotection and nerve repair, offering improved clinical outcomes for neurological disorders without adverse hematopoietic effects.

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Abstract

The present invention relates to the fields of biotechnology and medicine and describes pharmaceutical compositions of recombinant human erythropoietin characterized by a microheterogeneity of fucosylated N-glycans formed by di-, tri-, and tetra-antennary structures with mono- and bi-sialylated sialic acid residues representing 40-60% of total glycans, tri-sialylated sialic acid residues representing 40-43% of total glycans, and tetra-sialylated sialic acid residues representing 10-13% of total glycans. This glycosylation pattern confers properties that allow the composition to be used in disorders of the nervous system. Methods for obtaining the pharmaceutical compositions described herein are also described.
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