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Tag Archives: Haemtech Biopharma Services—

Thrombin generation assay for IVIG product, 11/13

Haemtech Biopharma Services announced the successful validation of a thrombin generation assay for an intravenous immunoglobulin drug. The assay was validated in 2012 to support the use of TGA as a release assay for Biotest Pharmaceuticals’ FDA biologics license application for BIVIGAM, an immune globulin intravenous (human), 10 percent liquid product. The validated TGA assay was designed and performed on the Calibrated Automated Thrombogram platform from Diagnostica Stago.

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