Global assays are a new class of coagulation assays measuring one parameter in response to the total coagulation cascade. Global assays are an essential tool for in-depth analysis of blood coagulation, fibrinolysis and its interplay. With the capacity to measure thrombin and plasmin generation using our previously developed Novel Hemostasis Assay 1,2 or the recently developed micro thrombin and plasmin generation (maximum 20 µl of blood plasma) multiple parameters will be derived in just one plasma sample. Global haemostasis assays appear to be useful in evaluating overall haemostatic capacity both in the hemorrhagic or thrombotic field. Moreover, thrombin and plasmin generation is a powerful technology with a wide variety of applications in pharmaceutical development and clinical research. With our long history in global assay research, we have extensive experience to perform dedicated functional testing of pharmaceutical products.
Accurate coagulation factor testing is imperative in clinical practice and in pharmaceutical research and development activities to bring novel coagulation therapies to market. In addition to the micro global assays Enzyre developed micro quantitative coagulation assays for coagulation factors or anticoagulants like the novel class of Direct Oral AntiCoagulants (DOACs) and other inhibitors 3,4. Our excellent mode of operation allows fast, precise and reliable measurements of coagulation factor activity testing for our customers.
When you outsource your PK/PD analyses to Enzyre Service Facility, you get more than just a service organization: you get access to the best minds in science. With more than 25 years of experience in laboratory services we'll deliver fast and top-level results. Pharmacokinetic /-dynamics (PK/PD) analysis of coagulation factors requires different solutions from those traditionally employed in the analysis of pharmaceuticals. We have experience in the development and validation of PK/PD assays for the measurement of coagulation factors even in small volume pediatric samples 5,6.
Developing novel biomarker assays requires a great deal of time, a high level of expertise, and often comes with high expenses. We offer consultancy and services for biomarker discovery, validation and assay development in plasma and also derivatives of blood, such as saliva 7,8. With ample experience Enzyre Service Facility provides technical expertise, a high quality standard and a comprehensive approach for your preclinical or clinical stage sample analysis.
To assess our quality we participate in the external quality control of the ECAT foundation for the services we offer. We participate in the program for the one-stage factor VIII, chromogenic factor VIII and thrombin generation assay.