Coagulation Factor IX Inhibitor Plasma, Mild (FIP), Lyophilized

Biologicals / Biologicals-Serum, Plasma-Human

4°C/-20°C

Supplied as a powder lyophilized from 1ml FIX inhibitor plasma. Normal citrated human plasma depleted of Factor IX using antibodies directed to FIX immobilized on agarose beads. A polyclonal antibody inhibitory to FIX has been added to provide FIX neutralizing activity. Plasma contains 20mM HEPES.

Factor Inhibitor Plasma Products:
Coagulation Factor Inhibitor Plasmas (FIPs) are produced from normal human plasmas from which specific factors have been removed by selective affinity immuno-adsorption and an antibody inhibitory to the specific factor is added to provide neutralizing activity. These products can be used as a substitute for plasmas from patients that have developed neutralizing antibodies to coagulation factors. All of these products are intended for research use only.

Advantages:
Availability: FIPs are an economical and reliable alternative to human clinical source material that can be very difficult to obtain. Even samples form extremely rare conditions can be emulated in this way. FIPs are available in volumes ranging from 1ml vials up to bulk volumes.

Activity: FIPs are produced to one or more inhibitor activity categories:
•Mild:1-10 BU/ml
•Moderate:≥10-50 BU/ml
•Severe:≥ 50-200 BU/ml
The inhibitor potency is measured by standard Bethesda activity assay.

Tests Performed:
PT (HemosIL P-fib)
APTT (HemosIL APTT-SP)
Fibrinogen (clottable)
FIX (activity)
FIX Inhibitor activity (Bethesda assay*)

*Bethesda assay performed at 1:6 dilution, then mixed with an equal volume of normal plasma and incubated at 37ºC for 120 minutes. The FIX activity was measured by one stage clotting assay and the residual FIX activity was calculated as a percentage activity compared to a buffer control run in parallel. The residual FIX activity is converted to Bethesda units using the Bethesda graph or chart. The Bethesda value derived (BU/mL) is multiplied by the initial dilution of the sample to obtain the corrected inhibitor concentration.

Form:
Normal citrated human plasma depleted of Factor IX using antibodies directed to FIX immobilized on agarose beads. A polyclonal antibody inhibitory to FIX has been added to provide FIX neutralizing activity. Plasma contains 20mM HEPES.

Storage and Stability:
Prior to reconstitution, lyophilized plasma should be stored at 4°C. Lyophilized product is stable for 12 months after receipt. Reconstitute each vial with 1ml reagent grade water. Allow contents to dissolve for 15 minutes at room temperature with occasional stirring. Stability afte reconsitution is 4 hours at ambient temperature (18-25°C) or 30 days at -20°C.

Consistency: Using antibodies of known neutralizing activity and factor-deficient plasma, much greater control of potency between lots is achieved.

Safety: FIPs are made from normal plasma tested at source and found negative for HCV, HIV and HBV. In contrast, clinically derived samples are inherently high risk samples.