Enzyme compositions with reduced viral and microbial contamination
AssigneeAbbVie Inc.
InventorsMartin Babcock, Cynthia Burnell, Vikram Kalthod, Joerg Breitenbach, Frithjof Sczesny, Frauke-Regina Rueffer, George Shlieout
Life of this patent
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Abstract
The present invention pertains to an enzyme preparation obtained from e-beam irradiated animal tissue, such as porcine pancreas. The present invention also pertains to methods for making such enzyme preparations, pharmaceutical compositions comprising such enzymes preparations, and methods for using such pharmaceutical compositions and enzyme preparations.
Claims35
An enzyme preparation produced by a method comprising the steps of:
- (a) subjecting intact mammalian pancreatic tissue to electron beam radiation to produce irradiated pancreatic tissue, wherein the electron beam radiation is sufficient to produce at least a four log10 reduction in viral load of a model virus compared to a control sample;
- and
- (b) isolating pancreatin from the irradiated pancreatic tissue, wherein a biological activity of the pancreatin obtained in step (b) corresponds to at least 50% of the biological activity of a control enzyme preparation.
An enzyme preparation comprising one or more enzymes isolated from an electron beam irradiated, intact pancreatic tissue, wherein a biological activity of the enzyme preparation corresponds to at least 90% of the biological activity of a control enzyme preparation.
A pancreatin product produced by a method comprising the steps of:
- (a) mechanically processing a frozen, intact pancreas gland or intact lobe thereof to obtain frozen blocks or flakes;
- (b) irradiating the frozen blocks or flakes in a container at a dose sufficient to produce at least a four log10 reduction in viral load of a model virus compared to a control sample, wherein the container is substantially free of flammable solvent;
- and
- (c) processing the irradiated blocks or flakes to obtain pancreatin;
- wherein a biological activity of the pancreatin corresponds to at least 90% of the biological activity of a control enzyme preparation.
A pancreatin product produced by a method comprising the steps of:
- (a) mechanically processing a frozen, intact pancreas gland or intact lobe thereof to obtain frozen blocks or flakes;
- (b) subjecting the frozen blocks or flakes to electron beam irradiation at a dose sufficient to produce at least a four log10 reduction in viral load of a model virus compared to a control sample, wherein the frozen blocks or flakes are irradiated in a container that is substantially free of flammable solvent;
- and
- (c) processing the irradiated blocks or flakes to obtain pancreatin;
- wherein a biological activity of the pancreatin corresponds to at least 90% of the biological activity of a control enzyme preparation.
Dependencies are inferred from the claim text.