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A factor VII concentrate for therapeutic use

G W Dike, D Griffiths, E Bidwell

British Journal of Haematology

|May 1, 1980

Summary

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This study developed a new method to concentrate and purify factor VII from human plasma, achieving a 50-fold increase in purity for therapeutic use. The concentrate was safely administered to patients with factor VII deficiency, showing effective therapeutic results.

Area of Science:

Biochemistry
Hematology
Plasma Fractionation

Background:

Factor VII deficiency can be congenital or acquired, necessitating effective therapeutic concentrates.
Large-scale plasma fractionation is crucial for producing various therapeutic proteins.

Purpose of the Study:

To develop a method for preparing a highly purified and concentrated factor VII suitable for therapeutic applications.
To evaluate the efficacy and safety of the prepared factor VII concentrate in patients with factor VII deficiency.

Main Methods:

Factor VII was isolated from human plasma supernatant after initial fractionation steps.
DEAE-Sepharose batch adsorption and subsequent chromatographic elution were employed for concentration and purification.
The concentrate was administered to patients with congenital and acquired factor VII deficiency.

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Main Results:

Factor VII was concentrated approximately 25-fold and purified about 50-fold compared to original plasma.
In six patients with congenital deficiency, plasma factor VII levels rose by 95-100% of theoretical, with a half-disappearance time of approximately 4 hours.
Treatment of four patients with acquired deficiency was also successful, with no observed adverse effects.

Conclusions:

A robust method for producing therapeutic-grade factor VII concentrate from human plasma has been established.
The developed factor VII concentrate is effective and safe for treating both congenital and acquired factor VII deficiencies.
This method offers a significant advancement in the production of factor VII for clinical use.