Methods for screening pancrelipase for RNA virus contamination comprise removing free viral RNA from the pancrelipase, denaturing any viruses in the pancrelipase to release encapsidated RNA into the pancrelipase milieu, and detecting this released RNA. Removal of free viral RNA may comprise treating pancrelipase with RNase and DNase or precipitating the protein fraction of pancrelipase with a salt that precipitates the protein fraction while leaving nucleic acids such as RNA in solution. Pancrelipase substantially devoid of free nucleic acid is also provided.

Methods for screening pancrelipase for RNA virus contamination comprise removing free viral RNA from the pancrelipase, denaturing any viruses in the pancrelipase to release encapsidated RNA into the pancrelipase milieu, and detecting this released RNA. Removal of free viral RNA may comprise treating pancrelipase with RNase and DNase or precipitating the protein fraction of pancrelipase with a salt that precipitates the protein fraction while leaving nucleic acids such as RNA in solution. Pancrelipase substantially devoid of free nucleic acid is also provided.

A pancreatin preparation having reduced viral infectivity includes one or more pancreatin enzymes and peracetic acid (PAA). At least one pancreatin enzyme may be derived from an animal source such as a porcine pancreas gland. In a particular embodiment, the one or more pancreatin enzymes are selected from the group consisting of lipases, proteases, and amylases.

A pancreatin preparation having reduced viral infectivity includes one or more pancreatin enzymes and peracetic acid (PAA). At least one pancreatin enzyme may be derived from an animal source such as a porcine pancreas gland. In a particular embodiment, the one or more pancreatin enzymes are selected from the group consisting of lipases, proteases, and amylases.

Processes for separating an infectious viral load from a pancreatin sample and for quantitatively determining the viral load in a pancreatin sample are described herein.

Processes for separating an infectious viral load from a pancreatin sample and for quantitatively determining the viral load in a pancreatin sample are described herein.

A method for the reduction or inactivation of viral and microbial content in the manufacturing of pancreatin API is disclosed. The method includes treating animal-derived tissue with peracetic acid to reduce viral activity and bacterial load prior to processing. In particular, the method includes treating porcine pancreas glands with peracteic acid prior to extracting a pancreatin API from the treated glandular tissue.

A method for the reduction or inactivation of viral and microbial content in the manufacturing of pancreatin API is disclosed. The method includes treating animal-derived tissue with peracetic acid to reduce viral activity and bacterial load prior to processing. In particular, the method includes treating porcine pancreas glands with peracteic acid prior to extracting a pancreatin API from the treated glandular tissue.

Processes for separating an infectious viral load from a pancreatin sample and for quantitatively determining the viral load in a pancreatin sample are described herein.

Processes for separating an infectious viral load from a pancreatin sample and for quantitatively determining the viral load in a pancreatin sample are described herein.