C5/FB-Dpl is normal human serum in which C5 and factor B (fB) have been removed by immunoaffinity chromatography. The product is tested for the absence of C5 and factor B activity by testing classical and alternative pathway function and for the absence of C5 and factor B proteins by double immunodiffusion. The C5/FB-Dpl is certified to exhibit less than 5% classical pathway and alternative pathway activities. A functional alternative pathway is restored by addition of purified C5 (75 ug/mL) and factor B (200 ug/mL) (Morgan, B.P. (2000); Dodds, A.W. and Sim, R.B. (1997)). Similarly, a functional classical pathway is restored after reconstitution with purified C5 protein (75 ug/mL) indicating that all other complement components necessary for classical and alternative pathway activation are present. The function of the lectin pathway is not tested.
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