Manufacturing Process

Safety in Every Step — From Donor Screening to the Final Product

Koāte-DVI is made from donated human plasma. Today, plasma-derived therapies are effectively used to treat many life-threatening conditions. All plasma-derived therapies undergo viral removal and/or inactivation steps during production. These steps are effective in helping to inactivate or remove potential risks from infectious agents.1–3

In total, manufacturing Koāte-DVI involves multiple steps that are focused on safety. The manufacturing process for Koāte-DVI involves multiple steps focused on viral safety, including two independent steps to inactivate or remove viruses.

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

Koāte-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.

References: 1. Data on File, Kedrion Biopharma Inc. 2. Plasma Protein Therapeutics Association. Saving & Improving Lives: Plasma Protein Therapies. 3. National Heart Lung and Blood Institute. Hemophilia.