A collaborative study to establish a U.S. reference for tissue plasminogen activator (t-PA)
| Autor: | Laura L. Wood, Deborah P. Beebe |
|---|---|
| Rok vydání: | 1991 |
| Předmět: |
Pharmacology
medicine.medical_specialty General Immunology and Microbiology business.industry Bioengineering General Medicine Reference Standards Applied Microbiology and Biotechnology Tissue plasminogen activator World health Recombinant Proteins United States Clot lysis Tissue Plasminogen Activator Immunology medicine Potency Humans Medical physics business Reference standards Plasminogen activator Biotechnology medicine.drug |
| Zdroj: | Biologicals : journal of the International Association of Biological Standardization. 19(3) |
| ISSN: | 1045-1056 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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