Frozen Platelet Compositions Treated with Electron Beam Radiation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing methods for reducing pathogens in biologic materials like platelet compositions often degrade desired biological activities, necessitating a method that effectively reduces pathogens while maintaining beneficial biological activities.
Innovation Solution
Irradiating a frozen composition comprising a platelet concentrate or platelet lysate with electron beam radiation at doses effective to reduce pathogens by at least a 3-Log reduction, while maintaining substantial levels of bioactive factors such as FGFb, EGF, PDGF-AB, PDGF-BB, and TGF-β.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional pathogen reduction techniques are applied to biologic materials, then pathogen levels are reduced, but desired biological activities are degraded
Solution Approach 1:
The patent applies electron beam irradiation at controlled doses (15-75 kGy) to frozen platelet compositions, changing the physical state (frozen) and energy parameters (e-beam dose) to achieve pathogen reduction while preserving growth factors. This resolves the contradiction by finding optimal parameter ranges that eliminate pathogens without degrading biological activity.
Solution Approach 2:
The patent utilizes the frozen state (phase transition) of the platelet composition during e-beam irradiation. The frozen state protects bioactive factors from radiation-induced degradation while still allowing effective pathogen reduction, thus resolving the contradiction between pathogen elimination and biological activity preservation.
2Reliability
If higher doses of e-beam radiation are applied, then pathogen reduction is improved, but bioactive factor retention deteriorates
Solution Approach 1:
The patent establishes optimal e-beam dose parameters (15-75 kGy, preferably 25-50 kGy) that achieve adequate pathogen reduction (≥3-log reduction) while maintaining growth factor levels above 50% of initial concentrations. This parameter optimization resolves the contradiction by identifying the dosage window where both objectives are achieved.
Solution Approach 2:
The platelet composition is frozen before e-beam irradiation. This preliminary action of freezing protects the growth factors from radiation damage while still allowing effective pathogen reduction at lower doses, thus resolving the contradiction between pathogen elimination and growth factor preservation.
3Object-affected harmful factors
If pathogen reduction is achieved through conventional methods, then safety is improved, but therapeutic efficacy is reduced
Solution Approach 1:
The patent uses e-beam irradiation at 15-75 kGy doses on frozen compositions to achieve ≥3-log pathogen reduction while maintaining ≥50% growth factor activity. This resolves the contradiction by changing the treatment parameters (e-beam dose, frozen state) to simultaneously achieve safety and efficacy.
Solution Approach 2:
The frozen state acts as an intermediary protective medium during e-beam irradiation. It allows the radiation to effectively kill pathogens while shielding the growth factors from damage, thus resolving the contradiction between pathogen elimination and therapeutic activity preservation.
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
The method achieves a significant reduction in pathogens while retaining at least 50% of the initial levels of bioactive growth factors, making it effective for use in cell culture and medical treatments.
Implementation Method 1
irradiating a frozen composition comprising a platelet concentrate or a platelet lysate with electron beam radiation
Implementation Method 2
applying cooling to the frozen composition during the irradiating. The frozen composition can be at a temperature below about −20° C., more preferably below about −40° C., at the commencement of the irradiating, and in some embodiments can be maintained at such temperatures during the irradiating
Data Source
AI summary
Disclosed are methods for treating platelet compositions (e.g. platelet concentrates and/or platelet lysates) with electron beam radiation, where the compositions are in a frozen state during irradiation with the e-beam radiation. The methods can be conducted using e-beam radiation at doses effective to reduce the pathogen content of the compositions while retaining highly beneficial bioactivities of the compositions. Also disclosed are compositions preparable by the methods, and methods and compositions involving the use of the e-beam treated materials.