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
Thrombin BIOFAC For hemostatic applications
UNLOCK THE POWER OF NATURAL HEMOSTASIS
Since the mid-20th century, thrombin has been widely used as a local hemostatic agent, particularly for controlling minor capillary bleeding where conventional methods such as sutures or cautery are ineffective or impractical. Traditionally, it is applied as a reconstituted powder to promote localized clot formation and support wound sealing [1; 2].
BIOFAC’S THROMBIN
By taking advantages of our 75 years of expertise in the pharmaceutical and nutraceutical industries, BIOFAC produces the highest quality THROMBIN on the market, and it comprises:
- High purity and consistent bioactivity makes it suitable for topical use in surgical, trauma, and diagnostic applications (TCT testings).
- Full traceability from raw material to finished product, using only sources from BSE risk-eligible regions to guarantee safety and regulatory compliance.
- Virus validated and GMP-certified Thrombin, produced in our GMP certified factory located in Denmark, guaranteeing highest quality and safety standards.
- Our flexible production line allows us to produce according to customer specifications.
A PROVEN TOOL FOR TRADITIONAL SURGICAL HEMOSTASIS AND DIAGNOSTIC APPLICATIONS
BIOFAC Thrombin is a high-purity, bovine-derived serine protease intended for topical use in
surgical settings. It plays a central role in the coagulation cascade by catalyzing the conversion
of fibrinogen to fibrin at the site of bleeding to enhance local clot formation and promote wound
sealing [1; 4].
BIOFAC Thrombin
Bovine-Derived Hermostatic Agent
Thrombin BIOFAC
For Medical Device Solutions
UNLOCK THE NEXT GENERATION OF HEMOSTATIC INNOVATION
While thrombin has a long history of use as a topical hemostatic agent in surgery, recent advancements have expanded its applications far beyond traditional powder formats [1-3]. Modern delivery systems and combined formulations now allow for targeted, efficient, and user-friendly bleeding control, even in high-risk or prehospital settings (4-6).
BIOFAC Thrombin is a versatile ingredient suitable for integration into next-generation hemostatic devices and trauma care products, offering both rapid clot formation and excellent biocompatibility.
BIOFAC’S THROMBIN
- High purity and consistent bioactivity makes it suitable for incorporation in patches, films, gels, and sprays.
- Full traceability from raw material to finished product, using only sources from BSE risk-eligible regions to guarantee safety and regulatory compliance.
- Virus validated and GMP-certified Thrombin, produced in our GMP certified factory located in Denmark, guaranteeing highest quality and safety standards.
- Our flexible production line allows us to produce according to customer specifications.
ADVANCING HEMOSTASIS THROUGH INNOVATION IN WOUND CARE AND DEVICE INTEGRATION
BIOFAC Thrombin is a high-purity, bovine-derived serine protease increasingly applied in advanced wound care and medical devices. Designed for topical use, it supports hemostasis in complex clinical settings by rapidly converting fibrinogen to fibrin at t he bleeding site — enabling precise clot formation and improving control of moderate to severe bleeding in trauma, vascular access, and surgical procedures (4-6).
NEWER USE AND INNOVATIONS BIOFAC Thrombin For Medical Derived
Storage and Stability
BIOFAC Thrombin should be stored in original and tightly closed containers at 2-8 °C. Retest date is 3 years from date of production, if stored as advised. All products are primarily packed in approved-, light- and airtight corning bottles followed by aluminum bags.
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Regulatory Compliance
BIOFAC Thrombin production is GMP- certified by Danish Health and Medicines Authorities. BIOFAC Kastrup holds a Manufacturer’s Autorization for biological products
BIOFAC Thrombin Drug Master File is only available upon request for registration purposes
BIOFAC Thrombin is of bovine origin, the production process is virus validated
Danish Environmental Protection Agency (Danish EPA) has made a categorization of BIOFAC as to an instruction No. 6 of 2004 on Differential Environmental Review and assessed that BIOFAC is placed in Category 1 (the best category) because of the high level of systematism and high level of regulatory compliance.
Danish Working Environment Authority has given BIOFAC a green Smiley, indicating that BIOFAC has no issues with the Working Environment Authority, providing a high level of health and safety
