Thrombin (GMP)
BIOFAC supplies a virus validated and GMP-certified Thrombin in compliance with USP and JP.
BIOFAC Thrombin in surgical hemostasis and trauma dressing products
BIOFAC Thrombin can be used in
- Thrombin solutions indicated as an aid to hemostasis, whenever oozing blood and minor bleeding from capillaries and small venues are accessible. In various types of surgery, solutions of thrombin may be used in conjunction with an absorbable gelatin sponge for hemostasis.
- Hemostatic pads with thrombin applied topically and indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters and tubes.
- Thrombin gels, thrombin/gelatin foam hemostats, applied topically and indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters and tubes.
BIOFAC Thrombin in blood tests
BIOFAC Thrombin can be used for measuring the Thrombin Clotting Time. TCT is a blood test that measures the time it takes for a clot to form in the plasma of a blood sample containing anticoagulant, after an excess of thrombin has been added. It is used e.g. to diagnose blood coagulation disorders.
BIOFAC Thrombin grades
We produce thrombin according to both the USP and the JP.
BIOFAC Thrombin is available as a lyophilized powder with a specific activity up to 1800 iu /mg.
We supply BIOFAC Thrombin in bulk form as a lyophilized powder or as a powder lyophilized directly into vials.
Our flexible production unit is specifically dedicated to the production of BIOFAC Thrombin and allows us to supply different grades to suit our customers´ specifications
Storage and Stability
BIOFAC Thrombin must be stored in a cold place at less than 9 º C. in original tight containers.
The product is stable at these conditions for at least 36 months.
Thrombin functions
Thrombin has a long history in surgical hemostasis, and has proven to be an effective ancillary for surgical hemostasis.
Thrombin has a number of well-studied biological activities, which serve to achieve coagulation and hemostasis. In addition to the coagulation cascade, thrombin act directly on a number of cell types, e.g. Thrombin causes vasoconstriction on smooth muscle cells.
BIOFAC Thrombin in hemostatic products
BIOFAC Thrombin has found its application in a variety of trauma dressing products, as hemostatic pads and thrombin hemostat in a foam gel form. Furthermore, it can be used in a thrombin solution to be applied in various types of surgery.
BIOFAC Thrombin for blood tests
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Regulatory Compliance
- BIOFAC Thrombin production is GMP-certifiedby Danish Health and Medicines Authorities. BIOFAC Kastrup holds a Manufacturer’s Autorization for biological products
- BIOFAC Thrombin Drug Master File is available upon request
- BIOFAC Thrombin is of bovine origin, the production process is virus validated