LIU, Shengjiang,TITONG, Allison,WANG, Wensheng,SPADONI, Nicholas
申请号：
USUS2018/050579
公开号：
WO2019/055463A1
申请日:
2018.09.12
申请国别(地区):
US
年份:
2019
代理人:
摘要：
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 biologies, 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).La présente invention concerne des procédés destinés à être utilisés dans l'inactivation de virus. Les procédés d'inactivation de virus avec des N-méthylglucamides sont applicables au procédé de purification de médicaments biologiquement actifs tels que des sous-unités protéiques, des protéines (enzymes, facteurs, etc.), des protéines recombinantes, des anticorps, des vaccins ou des produits thérapeutiques géniques. Les détergents utilisés dans ce procédé sont basés sur de multiples homologues de N-méthylglucamide, constitués d'une fraction de glucose hydrophile et d'une queue d'acide gras hydrophobe, liées par une liaison amide. De plus, ces déter
