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Related Experiment Videos

B-domain deleted recombinant factor VIII formulation and stability.

T Osterberg1, A Fatouros, E Neidhardt

  • 1Pharmacia AB, Stockholm, Sweden.

Seminars in Hematology
|July 13, 2001
PubMed
Summary

A new B-domain deleted recombinant factor VIII (BDDrFVIII) formulation eliminates the need for blood-derived products, reducing pathogen transmission risks. This stable lyophilized product maintains factor VIII activity for extended storage and post-reconstitution use.

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Area of Science:

  • Biochemistry
  • Hematology
  • Pharmaceutical Sciences

Background:

  • B-domain deleted recombinant factor VIII (BDDrFVIII) is a modified form of human coagulation factor VIII.
  • Existing recombinant factor VIII products may contain human serum albumin (HSA), a blood-derived product.
  • The presence of HSA introduces a risk of transmitting blood-borne pathogens.

Purpose of the Study:

  • To develop a novel lyophilized formulation of BDDrFVIII.
  • To create a formulation free from blood-derived products like HSA.
  • To ensure the safety and stability of the new BDDrFVIII formulation.

Main Methods:

  • Development of a highly purified BDDrFVIII lyophilized formulation.
  • Exclusion of blood-derived products, specifically HSA.

Related Experiment Videos

  • Analysis of formulation composition upon reconstitution with saline.
  • Assessment of long-term stability using various analytical methods.

    • Main Results:

    • The BDDrFVIII formulation is free of blood-derived products, minimizing pathogen transmission risks.
    • The lyophilized formulation contains sodium chloride, sucrose, L-histidine, calcium chloride dihydrate, and polysorbate 80.
    • The formulation ensures long-term stability, preserving factor VIII activity for at least 24 months at 8°C and 6 months at 25°C.
    • Reconstituted BDDrFVIII maintains potency for at least 100 hours at 25°C.

    Conclusions:

    • A novel, safe, and stable lyophilized BDDrFVIII formulation has been successfully developed.
    • This formulation eliminates the need for HSA, thereby reducing the risk of blood-borne pathogen transmission.
    • The product's stability and extended post-reconstitution potency support its potential for continuous administration.