Control testing of therapeutics for blood coagulation disorders

National Control Laboratory Batch Release 

The NIBSC is the National Control Laboratory for the United Kingdom with responsibility for the Independent Batch Release of biological medicines.   

• The Haemostasis Section is responsible for the Independent Batch Release testing of plasma-derived therapeutics for disorders of blood coagulation. 
• Product categories undergoing batch release testing cover a range of clinical indications:

Clinical indications for products undergoing batch release testing in Haemostasis

Product	Indications
Alpha-1-Proteinase inhibitor	Congenital alpha-1-proteinase inhibitor deficiency
Antithrombin Concentrates	Congenital antithrombin deficiency
Factor VIII Concentrates	Congenital factor VIII deficiency (haemophilia A); von Willebrand disease
Factor IX Concentrates	Congenital factor IX deficiency (haemophilia B)
Factor X Concentrate	Congenital factor X deficiency
Prothrombin Complex Concentrates	Congenital factors II and X deficiency; liver dysfunction; reversal of coumarin anticoagulants
Virus Inactivated Fresh Frozen Human Plasma	Complex coagulation factor deficiency (eg severe liver failure); rare deficiencies (eg factor V); reversal of coumarin anticoagulants; thrombotic thrombocytopoenic purpura

• Laboratory tests undertaken for National Control Laboratory Batch Release are accredited to quality standard ISO17025.

National Control Laboratory Batch Release product areas and release tests

Product	Release tests
Alpha-1-Proteinase inhibitor	Alpha-1 potency; solubility & appearance
Antithrombin Concentrates	Antithrombin potency; heparin binding fraction; solubility & appearance
Factor VIII Concentrates	Factor VIII potency; VWF: function*; solubility & appearance (*as required)
Factor IX Concentrates	Factor IX potency; activated coagulation factors; solubility & appearance
Factor X Concentrates	Factor X potency; activated coagulation factors; solubility & appearance
Prothrombin Complex Concentrates	Factor IX potency; activated coagulation factors; thrombin; solubility & appearance
Virus Inactivated Fresh Frozen Human Plasma	Factor V potency; factor VIII potency; factor XI potency; blood group; activated partial thromboplastin time; appearance
All products	Manufacturer’s protocol evaluation; plasma pool viral markers (Blood Virology Section) – HBsAg, anti-HIV-1 and -2, HCV RNA

Product testing for markets outside the UK and Europe

Testing is also performed for products intended for markets outside the UK and Europe using identical procedures to that apply to National Control Laboratory Release testing. Certificates are issued following satisfactory laboratory analysis and checking of manufacturing protocols for compliance with the relevant national licence specifications.

Enquiries on Product Testing to: enquiries@nibsc.org