The Safety is in the Process

 

 

Each step in the manufacturing process is designed to increase the safety of Koate-DVI

  • The total process from donor collection to final product takes 7-9 months
  • Rigorous Donor Screening: only plasma from Qualified Donors is accepted
  • During the manufacturing process, plasma is tested twice for viral contamination in two different ways
  • Two specific viral inactivation steps effectively inactivate both enveloped and non-enveloped viruses
  • Validation studies measure the ability of each step in the manufacturing process to remove or eliminate viruses

There are ZERO documented cases of viral transmission associated with Koate-DVI1


Koate-DVI is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

Reference: 1. Data on File, Kedrion Biopharma Inc.