Animal Tissue Enzyme Preparation Using E-Beam Decontamination
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Solution Overview
Problem
Existing methods for inactivating viruses and spore-forming bacteria in enzyme preparations derived from animal tissue, such as pancreatic enzymes, often compromise the enzyme activity, and there is a need for a robust method that maintains enzyme potency while achieving significant viral and microbial reduction.
Innovation Solution
Subjecting animal tissue to electron beam radiation to reduce viral and microbial contamination by at least three log10, followed by isolating enzymes, which maintains at least 50% of the biological activity, particularly lipase activity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If heat treatment or solvent/detergent treatment is applied to inactivate viruses and spore-forming bacteria, then viral and microbial contamination is reduced, but enzyme activity is compromised
Solution Approach 1:
The patent changes the physical parameter from thermal/chemical treatment to ionizing radiation treatment. Electron beam radiation uses high-energy electrons to inactivate viruses and bacteria through direct energy deposition and free radical formation, bypassing the need for heat or chemicals that would denature enzymes. This parameter change enables simultaneous achievement of viral inactivation and enzyme preservation.
Solution Approach 2:
The patent replaces the mechanical/thermal system (heat treatment, solvent treatment) with a radiation-based system. Electron beam radiation delivers energy through electromagnetic interaction, causing ionization and excitation that inactivates biological contaminants without the mechanical stress of heat or the chemical denaturation of solvents, thereby preserving enzyme structure and function.
2Reliability
If extended dry heat treatment is applied to inactivate highly resistant viruses, then viral inactivation is achieved, but moisture content control and treatment time are significantly increased
Solution Approach 1:
The patent uses electron beam radiation to rapidly inactivate viruses by delivering high-energy electrons that directly damage viral genetic material and proteins. This radiation-based approach skips the extended time periods required by dry heat treatment, achieving viral inactivation in a fraction of the time without the need for prolonged exposure or strict moisture monitoring.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Achieves a high log10 reduction in viral and microbial contaminants while preserving at least 50% of the biological activity of enzymes, addressing the challenge of maintaining enzyme efficacy during processing.
Implementation Method 1
Subjects the animal tissue to electron beam radiation to reduce the viral and microbial contamination
Data Source
AI summary
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.