Abstract: 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.
Type:
Grant
Filed:
August 22, 2018
Date of Patent:
April 9, 2024
Assignee:
SCIENTIFIC PROTEIN LABORATORIES, LLC
Inventors:
Kenneth S. Manning, Yan Wang, Dustin Nielsen, Ryan Ruf, Colin Crowley, Jon Restivo, Dana Spangenberg, Karla Anhalt, Mark Romich, Anisha Akula, Carmen Fritz
Abstract: 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.
Type:
Application
Filed:
August 22, 2018
Publication date:
December 20, 2018
Applicant:
Scientific Protein Laboratories, LLC
Inventors:
Kenneth S. Manning, Yan Wang, Dustin Nielsen, Ryan Ruf, Colin Crowley, Jon Restivo, Dana Spangenberg, Karla Anhalt, Mark Romich, Anisha Akula, Carmen Fritz
Abstract: 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.
Type:
Grant
Filed:
May 19, 2016
Date of Patent:
October 9, 2018
Assignee:
Scientific Protein Laboratories, LLC
Inventors:
Kenneth S. Manning, Yan Wang, Dustin Nielsen, Ryan Ruf, Colin Crowley, Jon Restivo, Dana Spangenberg, Karla Anhalt, Mark Romich, Anisha Akula, Carmen Fritz
Abstract: Disclosed is a reverse-phase high-performance liquid chromatography based method for evaluating degradation pathways for panctreatin active pharmaceutical ingredients.
Abstract: 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.
Type:
Application
Filed:
May 19, 2016
Publication date:
February 9, 2017
Applicant:
Scientific Protein Laboratories, LLC
Inventors:
Kenneth S. Manning, Yan Wang, Dustin Nielsen, Ryan Ruf, Colin Crowley, Jon Restivo, Dana Spangenberg, Karla Anhalt, Mark Romich, Anisha Akula, Carmen Fritz
Abstract: Disclosed is a method for the separation, identification and quantification of multiple proteins in pancreatin active pharmaceutical ingredient samples.
Type:
Grant
Filed:
August 29, 2012
Date of Patent:
March 22, 2016
Assignee:
Scientific Protein Laboratories, LLC
Inventors:
Rachel Wezeman, Lin Rao, Kirk Cryer, Yan Wang
Abstract: Disclosed is a method for the determination of the absence or presence of bacillus cereus enterotoxin in a protein sample via a western blot.
Type:
Grant
Filed:
October 17, 2012
Date of Patent:
June 23, 2015
Assignee:
Scientific Protein Laboratories, LLC
Inventors:
Dustin Nielsen, Rachel Wezeman, Matthew Bristol, Mark Eifler, Lisa Petersen, Erik Walke, Lin Rao
Abstract: 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.