Plasma Protein Stabilization via Acidic pH Adjustment During Spray Drying
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Solution Overview
Problem
Current methods for storing and transporting blood plasma, such as Fresh-Frozen Plasma, require temperature-controlled environments to prevent degradation, which is costly and logistically challenging, and involve delays due to thawing requirements before use.
Innovation Solution
The use of novel formulations with citric acid or similar spray dry stable acidic substances (SDSAS) to maintain plasma pH during spray drying, reducing stress and improving recovery and stability of active proteins, allowing for easier rehydration with water and extended storage stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If Fresh-Frozen Plasma is stored using conventional freezing methods, then protein degradation is prevented, but storage cost and logistical complexity increase due to temperature-controlled requirements
Solution Approach 1:
The invention changes the pH parameter of the plasma to an acidic range (pH 3-6) using citric acid or similar acids, which fundamentally alters the stability characteristics of plasma proteins. This parameter change allows proteins to remain stable at higher temperatures without freezing, eliminating the need for complex temperature-controlled storage systems while maintaining protein integrity.
Solution Approach 2:
Citric acid or similar acids serve as an intermediary substance that mediates between the plasma proteins and the storage environment. The acid creates a protective acidic environment that prevents protein degradation and aggregation, allowing stable storage without freezing while maintaining protein functionality.
2Reliability
If Fresh-Frozen Plasma is stored at low temperatures, then protein degradation is prevented, but thawing time delays usage
Solution Approach 1:
By changing the pH to an acidic range and removing the need for freezing, the invention eliminates the phase change from frozen to thawed state. Plasma can be stored at refrigerated or ambient temperatures and is ready for immediate use without time-consuming thawing procedures, reducing loss of time while maintaining protein stability.
3Ease of operation
If plasma is spray dried to eliminate freezing requirements, then storage convenience improves, but protein degradation occurs due to shear stress, thermal stress, and pH changes
Solution Approach 1:
The invention applies preliminary action by adjusting the pH to an acidic range and adding protective agents before the spray drying process. This pre-treatment prepares the plasma to withstand the stresses of spray drying, preventing protein degradation while maintaining the convenience of dried powder storage and rapid reconstitution.
Solution Approach 2:
Protective agents and acidic pH conditions serve as beforehand cushioning that protects plasma proteins from the harmful effects of spray drying stresses. The acidic environment and protective substances cushion against shear stress, thermal stress, and pH changes during drying, ensuring protein stability while enabling convenient dried storage.
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
This approach enhances the recovery and stability of clotting factors like von Willebrand factor, enabling more convenient and cost-effective storage and rapid reconstitution of blood plasma, reducing the need for refrigeration and freezing, and improving the ease of rehydration with sterile water.
Implementation Method 1
The use of novel formulations with citric acid or similar spray dry stable acidic substances (SDSAS) to maintain plasma pH during spray drying
Implementation Method 2
During spray drying, some blood plasma proteins degrade to some extent, due to shear stress, surface stress (e.g., air-liquid interfacial stress), exposure to extreme pH, thermal stress, dehydration stress
Data Source
AI summary
A method of treatment of plasma with a physiologically compatible spray dry stable acidic substance (SDSAS) prior to or contemporaneously with spray drying of the plasma that results in greater recovery and greater long-term stabilization of the dried plasma proteins as compared to spray dried plasma that has not be subject to the formulation method of the present invention, as well as compositions related to plasma dried by the methods of the present invention.