Why Choose CSL Behring Fibrinogen and Thrombin?

We take responsibility for our Fibrinogen and Thrombin from plasma collection to product release

At CSL Behring, we’re dedicated to meeting or exceeding the most stringent international standards for plasma-product safety in accordance with guidelines from worldwide regulatory agencies. Our dedication to collecting safe plasma and producing the highest quality products via our Integrated Safety System is well known in our industry and includes:

  • CSL-owned collection centers
  • Strict donor selection and considerable donor screening
  • Extensive plasma testing/inventory hold before release for manufacturing
    – 5-NAT/PCR testing
  • CSL-owned fractionation manufacturing facility (Marburg, Germany)
  • Testing of plasma pools that goes beyond regulatory requirements
  • Virus inactivation and removal to reduce risk of transmission of infectious agents
  • Pharmacovigilance
We’re dedicated to providing a consistent and reliable supply of Fibrinogen and Thrombin
  • Our contract is our commitment to delivering the volume of Fibrinogen and Thrombin that you order
We only use US normal source plasma
  • All of our plasma, for further manufacturing purposes, is drawn in select FDA- and GHA-approved centers
  • Enhances batch-to-batch consistency
Our regulatory support is second to none

Clearing regulatory hurdles can be a great challenge both in terms of time and financial investment. CSL Behring’s regulatory experts provide support and answer questions concerning our Fibrinogen and Thrombin quickly and reliably. This helps our customers in their product registration efforts for pharmaceutical or biological products or medical devices that contain Fibrinogen and Thrombin.

CSL Behring performs testing to meet the needs of a globalizing marketplace

CSL Behring performs testing on lots in order to confirm their compliance with the regulations of US and European Union markets. Testing includes all tests that are required by the FDA and EMEA.

For such lots, Certificates of Analysis for each of these regions can be provided, each one stating the performed tests along with their requirements and results.