Intravenous immune globulin (IVIG) drugs are sterilized solutions of antibodies made from human plasma, and are used to treat primary immune deficiency and other immune-related conditions. IVIG drugs have, however, been linked to thrombotic events mediated largely by coagulation factor XI(a), which co-purifies with immune globulin as a contaminant. As a result, IVIG drug manufactures are recommended to routinely test the thrombogenicity of their IVIG product via detection of XI(a) activity in a specially designed thrombin generation assay.
What is a Thrombin Generation Assay (TGA)?
TGA is a universal test capable of assessing a research subject’s global hemostatic balance by measuring the overall tendency of a plasma sample to form thrombin after the initiation of coagulation. In the case of a drug product the TGA is applied to identify the factor XIa-like, pro-coagulant activity in the IVIG or other plasma-derived therapeutic. In this way, the thrombogenic potential of these drugs can be measured thus enabling manufacturers to increase the safety of their drug product, and to satisfy regulatory requirements.
What HBS Does For You
Haemtech Biopharma Services can develop and validate a TGA assay for your IVIG or other plasma-derived drug product. This includes the complete study of matrix effects as well as the development and manufacture of the appropriate control for your assay if required. Once the validation is complete HBS can then test your drug product in-house to produce data for FDA submission as well as for lot-release during manufacture for market placement.