METHODS OF INACTIVATION OF VIRUSES USING N-METHYLGLUCAMIDE AND ITS DERIVATIVES

    公开(公告)号:US20230143494A1

    公开(公告)日:2023-05-11

    申请号:US17975645

    申请日:2022-10-28

    CPC classification number: A01N37/20 C12N7/00

    Abstract: This disclosure relates to methods for use in inactivating viruses. The methods of inactivating viruses with N-methylglucamides is applicable to the purification process of biologically-active drugs such as protein subunits, proteins (enzymes, factors, etc.), recombinant proteins, antibodies, vaccine or gene therapeutic products. The detergents used in this method are based on multiple N-methylglucamide homologs, consisting of a hydrophilic glucose moiety and hydrophobic fatty acid tail, linked by an amide bond. Additionally, these sugar-based detergents are nonionic by nature, which do not disrupt the drug protein, plasma biologics, non-enveloped viral vaccine or adeno associated viral particles.
    A method of purifying a biological product solution of interest having an unidentified enveloped virus contaminant, including incubating a biological product solution of interest with a standard solution, inactivating any potential enveloped virus contaminant present in the biological product solution of step (a), measuring the inactivated virus present in the final solution of step (b), incubating a separate biological product solution of interest with a N-methylglucamide solution, measuring the inactivated virus present in the final solution of step (d), and comparing the results of the final solutions of step (c) and step (e).

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