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Continuous fractionation of human plasma.

G Mitra, J Lundblad

Biotechnology and Bioengineering

|July 1, 1978

Summary

Continuous processing of human plasma fractionation using the cold ethanol method achieved precise control over pH, flow, and temperature. This optimized process resulted in a 6-11% higher yield of plasma protein fractions and albumin compared to traditional batch methods.

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Area of Science:

Biochemical Engineering
Process Chemistry
Pharmaceutical Manufacturing

Background:

Traditional batch processing of human plasma fractionation is labor-intensive and can be inefficient.
The cold ethanol process is a standard method for separating plasma proteins but requires precise control.
Optimizing continuous processing offers potential for improved yield and consistency in plasma fractionation.

Purpose of the Study:

To implement and optimize a continuous processing system for human plasma fractionation via the cold ethanol method.
To achieve high-precision on-line control of critical process parameters.
To compare the yield of plasma protein fractions and albumin with traditional batch processing.

Main Methods:

Development and application of a continuous flow system for human plasma fractionation.
Implementation of on-line control systems for pH (+/- 0.05 units), flow (+/- 1%), and temperature (+/- 0.5°C).
Optimization of precipitation pH levels for target protein fractions, including albumin.
Investigation of the impact of pH overshoots during precipitation.

Main Results:

High-precision process control was successfully achieved for pH, flow rate, and temperature.
The irreversible nature of pH overshoots during precipitation was confirmed.
Continuous processing demonstrated a significant yield increase of 6-11% for plasma protein fractions and albumin compared to batch processing.

Conclusions:

Continuous processing of human plasma fractionation is feasible and offers superior control over critical parameters.
The optimized continuous method significantly enhances the yield of valuable plasma proteins.
This approach represents a substantial improvement over conventional batch processing for plasma fractionation.

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