Methods for purifying, detecting, and quantifying residual PEI-based transfection reagents

An acidic hydrolysis method effectively degrades viral vectors while preserving PEI-based transfection reagents, enabling precise detection and quantification in complex mixtures, ensuring patient safety in viral vector production.

JP7789941B2Active Publication Date: 2025-12-22ザルトリウス ポリプラス
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Patent Information

Application Number
JP2024548750
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2022-02-25
Filing Date
2023-02-24
Publication Date
2025-12-22
Estimated Expiration
2043-02-24

AI Technical Summary

Technical Problem

Current methods are inadequate for detecting and quantifying residual PEI-based transfection reagents in complex liquid mixtures containing biological matrices, which are essential for ensuring patient safety in viral vector production.

Method used

A method involving acidic hydrolysis is developed to degrade amide functional groups in viral vectors while preserving PEI-based transfection reagents, followed by purification and quantification of PEI-based transfection reagents, which are essential for ensuring patient safety in viral vector production.

Benefits of technology

The method allows for specific, sensitive, and robust detection and quantification of PEI-based transfection reagents, independent of the biological matrix composition, applicable to various virus types, and meets Good Manufacturing Practice (GMP) standards.

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Abstract

The present invention relates to a method for purifying, detecting and quantifying residual PEI-based transfection reagents.The present invention is directed to a method for performing an acidic hydrolysis of a liquid mixture comprising a biological matrix and a polyethylenimine (PEI)-based transfection reagent of general formula (I) as described herein, wherein the biological matrix comprises a recombinant virus or virus-like particle produced using the PEI-based transfection reagent, and wherein said acidic hydrolysis does not degrade the PEI-based transfection reagent.The present invention also relates to a method for purifying, detecting and / or quantifying the PEI-based transfection reagent of general formula (I) as described herein.
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Citation Information

Patent Citations

  • JP1700349

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  • Compositions for transfecting a nucleic acid molecule into a cell comprising triazole compounds grafted to a cationic polymer, and their applications

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