A factor VIII concentrate of intermediate purity and higher potency

Area of Science:

• Biochemistry
• Hematology
• Pharmaceutical Manufacturing

Background:

• Factor VIII concentrate is essential for treating hemophilia.
• Existing fractionation methods may have limitations in purity and yield.
• Optimizing concentrate production is crucial for patient safety and treatment efficacy.

Purpose of the Study:

• To modify an existing fractionation method for producing a higher purity Factor VIII concentrate.
• To assess the suitability of the improved concentrate for syringe injection.
• To evaluate the impact of plasma collection timing on concentrate yield.

Main Methods:

• Modified a fractionation method to include a contaminant precipitation step.
• Controlled temperature, pH, and ionic strength during precipitation.
• Analyzed 50 production-scale batches of the factor VIII concentrate.
• Compared plasma yields from whole blood frozen within 8 hours versus overnight storage.

Main Results:

• Achieved an intermediate purity factor VIII concentrate with a potency of approximately 12 IU/ml.
• Improved concentrate solubility and ease of filtration.
• Demonstrated no significant difference in overall yield whether plasma was harvested from whole blood within 8 hours or after overnight storage.

Conclusions:

• The modified fractionation method yields a purer, more soluble, and easily filterable factor VIII concentrate suitable for injection.
• Plasma collection timing does not significantly affect the overall yield, offering flexibility in blood donation processing.
• This optimized production process enhances the availability and usability of factor VIII concentrate for hemophilia treatment.