Scientific Protein Laboratories, LLC

Yan Wang

Anisha Akula

Karla Anhalt

Dustin Nielsen

Mark Romich

Ryan Ruf

Kenneth S Manning

Carmen Fritz

Colin Crowley

Jon Restivo

Dana Spangenberg

Rachel W Wezeman

Lin Rao

Kirk Cryer

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.

Method for reducing or inactivating viral and microbial content in the processes for the manufacture of pancreatin

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.

Disclosed is a reverse-phase high-performance liquid chromatography based method for evaluating degradation pathways for panctreatin active pharmaceutical ingredients.

Method for evaluating degradation pathways for pancreatin active pharmaceutical agents

Disclosed is a method for the separation, identification and quantification of multiple proteins in pancreatin active pharmaceutical ingredient samples.

RP-HPLC method for the analysis and quantification of pancreatin active pharmaceutical agents

A method for determining the amount of colipase in a pancreatin active pharmaceutical ingredient sample is provided, the method being a titrimetric method with a constant pH and temperature.

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Middleton, WI, United States of America

Yan Wang