Biostate Description

Biostate is a high purity, sterile, powder for injection containing a human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF) complex. Biostate is manufactured from human plasma donated by voluntary and non-remunerated donors from Hong Kong. The FVIII/VWF complex in Biostate is purified from cryoprecipitate using selective precipitation and size exclusion chromatography steps.
Von Willebrand Factor (VWF): Following reconstitution, 1 mL of Biostate contains: Biostate 50 IU FVIII/mL: approximately 100 IU of human plasma derived VWF.
The VWF activity of Biostate is determined using a VWF to platelet glycoprotein Ib 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 Biostate contains: Biostate 50 IU FVIII/mL: approximately 50 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 (FVIII:C). The specific FVIII activity of Biostate prior to the addition of human albumin as a stabiliser is approximately 50 IU of FVIII/mg protein.
Biostate contains other proteins such as fibrinogen, fibronectin, immunoglobulins (IgA, IgM, IgG) and transforming growth factor-β (TGF-β), all of which are present at significantly lower levels than in normal plasma.
Biostate is available in two different presentations as detailed in Table 1. The amount of VWF in the final product is dependent on the method of preparation of the cryoprecipitate, and this influences the VWF:FVIII ratio. Biostate contains VWF and FVIII in a ratio of 2:1. (See Table 1.)

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Physicochemical properties: CAS number: 9001-27-8.
Excipients/Inactive Ingredients: Human plasma proteins, Albumin stabiliser (≥99% pure), Sucrose, Sodium citrate dihydrate, Sodium chloride, Trometamol, Calcium chloride dihydrate, Sodium octanoate.