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Biostate - Human Coagulation Factor VIII and Human Von Willebrand Factor Complex) Powder and Diluent for Injection
Biostate is a high purity, sterile, powder for injection containing a human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF) complex. Biostate1 is manufactured from human plasma collected by Australian Red Cross Lifeblood. The FVIII/VWF complex in Biostate8 is purified from cryoprecipitate using selective precipitation and size exclusion chromatography steps.
Von Willebrand Factor (VWF)
Following reconstitution, 1 mL of Biostates contains:
- Biostate® 50 IU FVIII/mL: approximately 120 IU of human plasma derived VWF
- Bio state® 100 IU FVIII/mL: approximately 240 IU of human plasma derived VWF.
The VWF activity of Biostates is determined using a VWF to platelet glycoprotein lb binding activity assay (VWF:Ac). The VWF activity is expressed as international units (IU) and 1 IU VWF:Ac is equivalent to 1 IU VWF ristocetin cofactor (VWF:RCo) in accordance with the WHO standard. The specific VWF activity of the product prior to the addition of human albumin as a stabiliser is approximately 100 IU of VWF/mg protein.
Factor VIII (FVIII)
Following reconstitution, 1 mL of Biostate1 contains:
- Biostate® 50 IU FVIII/mL: approximately 50 IU of human plasma-derived coagulation FVIII
- Biostate® 100 IU FVIII/mL: approximately 100 IU of human plasma-derived coagulation FVIII.
The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The activity of FVIII is measured as FVIII coagulation activity (FVIILC). The specific FVIII activity of Biostate s prior to the addition of human albumin as a stabiliser is approximately 50 IU of FVIII/mg protein.