Potency assays for Anistreplase: comparison of the fibrin plate assay and a 96-well plate assay. |
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| Authors: | D P Beebe P J Gaffney D M van Schie |
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| Institution: | Division of Hematology, Center for Biologics Evaluation and Research, Bethesda, MD 20892. |
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| Abstract: | 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. |
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