Thrombin Generation Assays (TGA) for IVIG Drug Products

Thrombin Generation Assays (TGA)

What is a thrombin generation assay?

The thrombin generation assay (TGA) measures the overall hemostatic potential of a plasma sample. Unlike traditional clotting assays, such as PT and aPTT, which measure thrombin formation only during the initiation phase of coagulation, TGA measures thrombin formation throughout the entire clotting process. Since the majority of thrombin is generated after initiation, TGA provides a broader picture of total clotting potential. As such, it can be predictive of a patient’s bleeding or thrombotic risk.
Thrombin generation assay

Samples curves from a thrombin generation assay.

Pre-clinically evaluate your drug candidates

Plasma-derived drug products (e.g. IVIG) and recombinant replacement therapies have been linked to thrombotic events largely caused by contaminating pro-coagulant proteins. As a result, it is recommended that drug manufacturers routinely test the thrombogenicity of their drug products. Using a modified thrombin generation assay, pro-coagulant contaminants which may be present in your drug product can be detected and quantified. We can help you identify the contaminant, thus enabling manufacturing changes to mitigate the problem. For therapeutics where pro-coagulant contaminants aren’t a concern, TGA can be used to identify coagulation interferences that become apparent upon their introduction into plasma in-vitro.

Evaluation of clinical samples

When evaluating a drug candidate in vivo, measuring its affect on hemostasis is essential for drugs that treat hemostasis directly, or those that have potential off-target coagulation effects. The thrombin generation assay can measure your drug candidate’s impact on hemostasis by evaluating patient plasma samples throughout the clinical trial cycle. Using this information, drug manufacturers can increase the safety of their drug product to satisfy regulatory requirements.

What kind of drugs can be evaluated?

  • Intravenous immunoglobulins (IVIG)
  • Anticoagulant and antiplatelet therapies
  • Recombinant coagulation factors
  • Subcutaneous therapies
  • Antibody therapies
  • IV cancer therapies
  • AAV liver gene therapies

How Haemtech can help

We are recognized experts in blood coagulation and hemostasis. We specialize in validating the TGA, and other methods, to identify potential hemostatic effects related to your drug product. We can assist you from IND through batch release to get your product to market faster — and safer.

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