Potency assays for Anistreplase: comparison of the fibrin plate assay and a 96-well plate assay.
Several production lots of Anistreplase (Eminase) were assayed for potency by either two fibrin plate assays or a clot lysis assay performed in 96-well microtiter plates. The 96-well plate assay yielded comparable data to the fibrin plate assays and had the advantage of greater efficiency with respect to both time and reagents. As a result the newer method appears to be a suitable alternative to the fibrin plate assays for lot release of Anistreplase.
Beebe
D P
DP
Division of Hematology, Center for Biologics Evaluation and Research, Bethesda, MD 20892.
Gaffney
P J
PJ
van Schie
D M
DM
D000704:Analysis of Variance; D016255:Anistreplase / Q000032:analysis*; D005337:Fibrin; D005342:Fibrinolysis; D007700:Kinetics; D012015:Reference Standards
D016255:Anistreplase; D005337:Fibrin