The Synapse Research Institute follow the laboratory standards, required for clinical and pharmaceutical studies. The laboratory is ISO 9001:2015 and ISO 14001:2015 certified. Thrombin generation measurements in platelet poor plasma will be offered according to Good Laboratory Practice (GLP) standards. In addition, we have scientific laboratory facilities for flexible and custom made solutions in thrombosis and haemostasis research.
Thrombin generation according to the guidelines for Good Laboratory Practice (GLP)
Synapse laboratories thrombin generation facilities are performed according to the guidelines for Good Laboratory Practice (GLP). In 2017 the Synapse research Laboratories have passed an audit by CCDRD on: (1) ICH Topic E6 (R1). Guideline for Good Clinical Practice (CPMP/ICH/135/95), July 2002, (2) CHMP Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/135/95. Adoption by CHMP, 21 July 2011, and (3) Reflection paper for laboratories that perform the analysis for evaluation of clinical trial samples (EMA/INS/GCP/532137/2010). Adopted by GCP inspectors working group, 28 February 2012.
Thrombin Generation and Platelet Function Services
Thrombin generation services for clinical studies to thrombosis risks, bleeding risks, (side-) effects of direct oral anticoagulants (DOACs), (side-) effects of heparins, activated protein C resistance and anti-phospholipid syndrome phenotype.
Thrombin generation services in Platelet Poor Plasma
Thrombin generation services in Platelet Rich Plasma
Thrombin generation services in Whole Blood.
Quantify coagulation factor concentrations in plasma, using thrombin generation. This approach requires less plasma and detects extremely low factor concentrations (for example to measure factor VIII concentrations below 1%).
Platelet function research using agonist induced platelet activation in platelet rich plasma and in whole blood.
Testing the platelet function tolerance to medication, stents, heart valves, antibodies, etc
Platelet reactivity response can be tested against every biological or non-biological stimulator, which could be both endogenous and exogenous materials.
We also test sheer resistance and platelet deposition under flow to any surface of interest. Read out is scanning-EM.
Synapse investigators have a long record in haemostasis research, including real time video imaging of platelet thrombus formation and fibrin formation under flow. Furthermore, Synapse has the experience in analyzing perfusion experiments with scanning EM imaging, to investigate platelet and fibrin deposition on stents, heart valves or other biological samples.
Thrombin generation and fibrin formation do not always go hand in hand and flow profoundly influences thrombus formation. We developed and validated an assay to simultaneously measure thrombin generation and fibrin formation under conditions of physiological flow, using a rheometer.
Synapse has designed a specific substrate, which is specifically cleaved by plasmin. Similar to thrombin generation, we have developed a test to quantify plasmin generation in plasma.