Refrigerated Whole Blood Platelets for Extended HPL Production
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Solution Overview
Problem
The production of platelet lysate is limited by the time constraint of 8 hours from whole blood collection to separation, which is a barrier for producing sufficient quantities needed for cell and gene therapies.
Innovation Solution
Centrifuging whole blood units refrigerated below 15°C, optionally between 0°C to 10°C or 2°C to 8°C, to separate platelets, followed by refrigerated centrifugation at higher RPM to produce platelet concentrate, which can be used to make platelet lysate even after 8 hours post-phlebotomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If whole blood is stored at refrigerated temperature below 15°C for extended periods, then the production time window for platelet lysate is extended beyond 8 hours, but the platelets may suffer from cold storage damage and reduced functionality
Solution Approach 1:
The patent changes the storage temperature parameter to a refrigerated range (2°C to 8°C) that was previously considered too cold for platelet storage. This parameter change extends the storage time from 8 hours to up to 48 hours while maintaining platelet viability for lysate production, resolving the contradiction between storage duration and platelet functionality.
2Productivity
If conventional room temperature storage (20°C to 24°C) is used, then platelet separation must occur within 8 hours, but this limits the production quantity and scalability for cell and gene therapies
Solution Approach 1:
The patent applies preliminary action by refrigerating the whole blood units before platelet separation. This preliminary cooling step enables extended storage and processing time (up to 48 hours) before separation, allowing for larger batch processing and increased production quantity without being constrained by the 8-hour window.
3Duration of action of moving object
If whole blood units are refrigerated below 15°C prior to separation, then the production time window is extended to 48 hours, but this process deviates from FDA approved methods for transfusion-grade platelets
Solution Approach 1:
The patent extracts the platelets from the regulated transfusion pathway by using refrigerated storage conditions that are not FDA approved for transfusion purposes. This extraction allows the use of extended storage times (up to 48 hours) for lysate production specifically, bypassing the 8-hour constraint while maintaining regulatory compliance for the intended application.
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
Enables the production of human platelet lysate from refrigerated whole blood units up to 48 hours after collection, suitable for use in tissue culture and therapeutic applications.
Implementation Method 1
the whole blood undergoes centrifuging in a refrigerated centrifuge unit to thus separate components of the whole blood unit to produce platelet concentrate
Data Source
AI summary
Methods provided for producing human platelet lysates (HPL) typically from expired platelet units that were initially manufactured to be infused into patients. Whole blood units from which platelets will be prepared for transfusion are maintained at a temperature cooling toward room temperature. The platelet lysate produced by the method can be formed from platelets that have been removed from the refrigerated whole blood unit more than 8 hours after phlebotomy.