Patent ID: 7226775

Claim:
A method of removing bacterial endotoxin from a pharmaceutical process solution containing an amphiphilic pharmaceutical drug or vaccine, wherein said method comprises: a) treating the pharmaceutical process solution with a concentration of sodium deoxycholate that is effective to dissociate the endotoxin from the amphiphilic pharmaceutical drug or vaccine in the pharmaceutical process solution without affecting the ability of the drug or vaccine to be retained by a molecular cut-off filter having a pore size effective to retain the amphiphilic pharmaceutical drug or vaccine substance but allow the disassociated bacterial endotoxin to pass through; b) directly thereafter filtering the treated pharmaceutical process solution though a 30 kDa molecular weight cut-off filter; and c) thereafter, subjecting the filtered pharmaceutical process solution to a further process step in which the sodium deoxycholate is removed, wherein after this process step the amount of sodium deoxycholate remaining in the pharmaceutical process solution is less than 0.002%.