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
Synapse Research Institute harbors a standardized laboratory which is ISO 9001:2015 and ISO 14001:2015 certified. The institute offers thrombin generation services in Platelet Poor Plasma, Platelet Rich Plasma and Whole Blood, following the highest quality standards. These thrombin generation services may be used for clinical studies to investigate thrombosis risks, bleeding risks, (side-) effects of direct oral anticoagulants (DOACs), (side-) effects of heparins, activated protein C resistance and anti-phospholipid syndrome phenotype.
Synapse research laboratories have developed a thrombin generation based technique to quantify coagulation factor concentration in plasma. This technique has the advantage to existing coagulation factor measurements, that it requires less plasma and it can be used to measure extremely low factor concentrations (for example to measure factor VIII concentrations below 1%).
Synapse Research Institute has developed a flow cytometry based detection method of agonist induced Platelet Function in platelet rich plasma and in , whole blood. This technique can be used to measure platelet reactivity to biological or non-biological stimulators. We often use this technique to study the haemostatic tolerance to endogenous and exogenous materials.
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.