Drug candidate impact on hemostasis
Is your drug creating a clotting problem?
When evaluating drug candidates that treat hemostasis directly, or those that have potential off-target coagulation effects, understanding their impact on blood coagulation is essential. Several assays can measure a drug candidate’s impact on hemostasis by evaluating patient plasma samples throughout the clinical trial process. Using this information, drug manufacturers can increase the safety of their drug product to satisfy regulatory requirements. Therapies include:
- Anticoagulant (traditional and DOAC) and antiplatelet therapies
- Recombinant coagulation factor replacement therapies
- Intravenous cancer therapies
How Haemtech can help
We are experts in blood coagulation and hemostasis. We specialize in running methods to identify, understand and potentially mitigate negative 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. We offer:
- Thrombin generation assays – measure the overall hemostatic capacity of a plasma sample
- Whole blood clotting assays – test the activity of individual clotting factors in the blood
- PT and aPTT – focus on the extrinsic or intrinsic pathways of coagulation
- Platelet aggregation and activation assays
- Many others
Haemtech Biopharma Services is a QC/Clinical testing laboratory operating under cGMP/CLIA guidelines. Data is timely, accurate and fully supported for regulatory submission.
- FDA inspected/registered
- EMA certified for GMP