Process for preparing human immunoglobulin formulation for intravenous injection

WO2025241860A1PCT designated stage Publication Date: 2025-11-27SHANDONG BAIYI PHARMA
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Patent Information

Application Number
PCT/CN2025/092192
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-05-20
Filing Date
2025-04-29
Publication Date
2025-11-27

AI Technical Summary

Technical Problem

Existing processes for preparing intravenous human immunoglobulin have drawbacks, including low product purity, high polymer content, and a tendency to cause adverse infusion reactions. Furthermore, the traditional three-stage low-temperature ethanol method is complex, energy-intensive, and the ethanol solvent is flammable and explosive, affecting the structure and function of IgG.

Method used

The precipitate of components II+III was dissolved in a precipitating solution containing 0.8%-1.2% sodium dihydrogen phosphate and 0.66%-1.0% sodium citrate. After adding low-temperature ethanol, a filter aid powder was added and the mixture was filtered under pressure. The solution was purified by chromatography using a DEAE-Sepharose FF column. Finally, maltose was added as a protective agent to prepare the human immunoglobulin preparation for intravenous injection.

Benefits of technology

The prepared intravenous immunoglobulin preparation has an anticomplement activity of less than 7%, a purity of 99.3%-100%, good thermal stability, and reduces the risk of infusion reactions.

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Patent Text Reader

Abstract

The present invention belongs to the technical field of protein production. Provided is a process for preparing a human immunoglobulin formulation for intravenous injection. The preparation process provided in the present invention comprises: dissolving precipitates of components II + III with a dissolution solution containing 0.8%-1.2% of sodium dihydrogen phosphate and 0.66%-1.0% of sodium citrate, adding low-temperature ethanol, and then adding filter-aid mixed powder for pressure filtration, wherein the weight ratio of diatomite, cellulose and silicon dioxide in the filter-aid mixed powder is 4-5 : 2-3 : 1-1.5. The human immunoglobulin formulation for intravenous injection prepared in the present invention exhibits an anti-complement activity of only 5%-7%, has a relatively good thermal stability, and achieves a purity level of 99.3%-100%.
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Citation Information

Patent Citations

  • Productive technology of intravenous injection human immunoglobulin

    CN102552906A

  • Preparation method for human immunoglobulin for intravenous injection

    CN103554253A

  • Fraction I-IV-1 precipitation of immunoglobins from plasma

    CN104245730A

  • Method for preparing intravenous immunoglobulin

    CN104479011A

  • Production process of human immune globulin

    CN116731162A