Patent ID: 9063034
Filing Date: 2015-06-23
Classification: A61K,C12Q,G01N

Abstract:
1. A method for determining the absence or presence of one or more components of Bacillus Diarrheal Enterotoxin (BDE) in a pancreatin Active Pharmaceutical Ingredient (API) sample comprising separating the one or more components of BDE from the pancreatin API sample by sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), and identifying one or more components of BDE by using at least one probe antibody specific for at least one or more components of BDE; wherein the one or more components of BDE are selected from the group consisting of Hemolysin BL (Hbl), Nonhemolytic Enterotoxin (Nhe), Cytotoxin K (CytK) and Enterotoxin T (BcET).