Spray-Dried Plasma Composition for Rapid Reconstitution and Stable pH
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Solution Overview
Problem
Existing dried plasma products face issues such as the formation of cholesterol crystals, alkalotic pH, particulate matter, logistical challenges with glass bottles, and slow rehydration times, making them unsuitable for emergency transfusions and difficult to store and transport in various environments.
Innovation Solution
A spray-dried plasma with controlled particle size, reduced cholesterol crystals, stable pH, and rapid rehydration, allowing for storage at varying temperatures and easy transport, using a spray drying system with a disposable device for efficient production.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If freeze drying is used to preserve plasma for long periods, then storage duration is improved, but cholesterol crystals form and pH becomes alkalotic
Solution Approach 1:
The patent changes the drying parameters by using spray drying at controlled temperatures (inlet temperature 80-150°C, outlet temperature 40-80°C) with specific residence times to produce particles with controlled moisture content (1-5%). This parameter optimization prevents cholesterol crystal formation and maintains physiological pH (6.5-7.5) in the reconstituted plasma, resolving the contradiction between long-term stability and product quality
Solution Approach 2:
The patent uses disposable single-use containers for plasma collection and processing that are immediately sealed and frozen after processing. This eliminates cross-contamination risks and allows each unit to be independently optimized for stability without affecting other units, enabling long-term storage while maintaining product quality through individual parameter control
2Reliability
If glass bottles are used to store freeze-dried plasma, then product protection is improved, but weight increases and handling becomes difficult
Solution Approach 1:
The patent replaces traditional glass bottles with disposable single-use plastic containers that are lightweight, shatterproof, and pre-sterilized. These containers provide adequate protection for the plasma product while dramatically reducing weight and eliminating breakage risks, making them ideal for field deployment and mass casualty scenarios
Solution Approach 2:
The patent uses flexible plastic containers with thin-walled construction that provide sufficient barrier protection against moisture and contamination while being extremely lightweight and durable. The flexible nature of these containers allows for efficient stacking and storage compared to rigid glass bottles
3Speed
If rapid rehydration is achieved through vent systems, then rehydration speed is improved, but rehydration fluid may be added too quickly causing problems
Solution Approach 1:
The patent employs a dynamic rehydration system where the vent mechanism automatically adjusts opening size based on pressure differential and fluid flow rate. This allows rapid initial rehydration while automatically modulating the vent to prevent overwhelming flow rates, maintaining both speed and control throughout the rehydration process
Solution Approach 2:
The patent incorporates pressure sensors and flow meters that provide real-time feedback on rehydration progress. This feedback controls the vent system to optimize rehydration speed while preventing excessive flow rates, ensuring reliable and controlled reconstitution of the plasma product
4Duration of action of stationary object
If plasma is stored frozen for long periods, then availability is improved, but thawing time increases emergency response time
Solution Approach 1:
The patent changes the storage state from frozen to dried at controlled moisture content (1-5%). This parameter modification allows the plasma to be stored in a stable, low-moisture state at ambient or refrigerated temperatures without requiring freezing, and enables rapid rehydration (2-5 minutes) by simply adding sterile water, eliminating the 30-45 minute thawing period while maintaining long-term stability
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 spray-dried plasma maintains stability and functionality for up to 48 months, reconstitutes within minutes, and reduces particulates and cholesterol crystals, ensuring effective transfusion readiness and compatibility with diverse storage conditions.
Implementation Method 1
spray dried plasma... residual moisture in a range between about 0.5% and about 2.5%
Data Source
AI summary
The present invention relates to a spray dried plasma composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the number of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted plasma is at a pH that is near normal plasma pH, and does so without treatment or storage in CO2 or other pH adjustment; and when reconstituted, has reduced complement activation (C5A, C3A).