A collaborative study to establish a U.S. reference for tissue plasminogen activator (t-PA).
In 1987 the Second International Standard for tissue plasminogen activator (t-PA) was established by the World Health Organization following an international collaborative study. At that time, the Center for Biologics Evaluation and Research (CBER) decided to establish a national reference t-PA to be used in lot release potency testing of Alteplase, a licensed t-PA biological or of other t-PAs in development. A candidate recombinant t-PA (rt-PA) preparation was donated by Genentech, Inc. (South San Francisco, California) for this purpose and a collaborative study was launched to calibrate this material against the 2nd I.S. Four laboratories (including the Center for Biologics Evaluation and Research (CBER) and three manufacturers) participated in the study to establish the potency of the rt-PA preparation using a clot lysis assay. The results indicate that the potency of the U.S. reference for t-PA is 2900 international units (IU) per vial.
Beebe
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Blood Products Division, Center for Biologics Evaluation and Research, Bethesda, Maryland.
Wood
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LL
D006801:Humans; D011994:Recombinant Proteins / Q000592:standards; D012015:Reference Standards; D010959:Tissue Plasminogen Activator / Q000592:standards*; D014481:United States
D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator