A factor VII concentrate for therapeutic use

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.

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.