Haemtech Biopharma Services (HBS) is pleased to announce the successful validation of a thrombin generation assay (TGA) for an IVIG drug. The assay was validated in 2012 to support the use of TGA as a release assay for Biotest Pharmaceuticals Corporation’s U.S. Food and Drug Administration Biologics License Application for BIVIGAM® [Immune Globulin Intravenous (Human), 10% Liquid] product. The validated TGA assay was designed and performed on the Calibrated Automated Thrombogram® platform (CAT) from Diagnostica Stago, Inc. (Parsippany, NJ).
What is the Thrombin Generation (TG) Assay (TGA)?
TGA is a universal test capable of assessing a research subject’s global hemostatic balance in the case of hemorrhage or thrombosis. The CAT method is both specific and sensitive, thus giving increased relevance to hemostatic testing in academic research centers, pharmaceutical companies and contract research organizations.
“We are very proud to have been able to assist Biotest Pharmaceuticals Corporation on their rigorous path to BIVIGAM® regulatory approval. BIVIGAM is the first newly FDA approved Immune Globulin product to utilize a CAT based TGA assay,” said Richard Jenny, HBS’s President and CEO. “There has been an increasing push by regulatory authorities for plasma-based biotherapeutics manufacturers to improve upon methods used to determine the thrombogenic potential of their products. We believe the validation of this assay to be a significant step toward our ability to help all manufacturers meet this goal. We can now use our experience to offer TGA assay development, validation and implementation services to all plasma-derived drug product manufacturers looking to satisfy regulatory requirements,” he added.
Using this specific and effective method coagulation factor XIa-like, procoagulant activity can be measured in IVIG and other plasma-derived therapeutics. In this way, the thrombogenic potential of these drugs can be measured and thus enable manufacturers to increase the safety of their drug product, and satisfy regulatory requirements on the road to product submission.