Spray-Dried Plasma Fractionation Without Cold-Chain Storage
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Solution Overview
Problem
The existing methods for plasma fractionation require a cold-chain for storage and transportation of frozen plasma, which is logistically complex, resource-intensive, and costly, and the spray drying process can degrade plasma proteins, making it unsuitable for direct use in fractionation.
Innovation Solution
A plasma fractionation process starting with physiologically active spray dried plasma, which is reconstituted and then subjected to fractionation processes like cold ethanol fractionation, allowing for efficient and economical transportation and storage at room temperature or standard refrigeration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If plasma is stored in frozen state (FFP), then plasma proteins are preserved with high activity, but cold-chain storage and transportation are required which increases complexity and cost
Solution Approach 1:
The patent changes the storage temperature parameter from frozen (-18°C or below) to ambient temperature, enabling plasma to be stored without cold-chain infrastructure while maintaining protein functionality through the spray-drying process
Solution Approach 2:
The patent extracts water from plasma through spray-drying to create a concentrated powder form, eliminating the need for frozen storage while preserving protein activity. The water removal fundamentally changes the storage requirements
2Device complexity
If spray drying is used to eliminate cold-chain, then storage and transport become simpler, but plasma proteins may be degraded
Solution Approach 1:
The spray-drying process rapidly removes water from plasma in a short time period, minimizing the duration of thermal exposure and preventing protein degradation that would occur with prolonged heating
Solution Approach 2:
The patent optimizes spray-drying parameters including inlet temperature, outlet temperature, and feed rate to achieve water removal while maintaining protein stability. The rapid transition from liquid to powder form prevents degradation
3Ease of operation
If FFP is thawed before use, then plasma becomes usable, but 30-80 minutes delay occurs
Solution Approach 1:
The plasma is pre-dried into a stable powder form that can be stored at ambient temperature and rapidly reconstituted when needed, eliminating the lengthy thawing process while maintaining protein activity
4Reliability
If cold-chain is maintained for plasma storage, then protein degradation is prevented, but logistical cost and resource consumption increase
Solution Approach 1:
Water is extracted from plasma through spray-drying to create a stable powder that does not require cold-chain storage, fundamentally eliminating the energy consumption associated with freezing and thawing operations
Solution Approach 2:
The storage temperature parameter is changed from frozen to ambient, and the physical state is changed from liquid to powder, both of which eliminate the need for energy-intensive cold-chain infrastructure
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 process yields plasma proteins in fractions comparable to those from frozen plasma, reducing logistical and environmental impacts while maintaining protein activity and functionality.
Implementation Method 1
spray-drying is a technology in which a solution is atomized in a stream of flowing gas for rapid solvent vaporization (e.g., dehydration)
Implementation Method 2
submitting the physiologically active reconstituted plasma to one or more fractionation processes (e.g., cold ethanol fractionation)
Data Source
AI summary
The present invention provides a method of fractionating human plasma, in some embodiments, using the Cohn fractionation procedure. The improvement comprises the use of physiologically active reconstituted spray dried human plasma as the starting material for the fractionation procedure.