COMMITTED TO SAFETY
Each step in the KOĀTE manufacturing process is designed to increase the safety of KOĀTE.
On its own, the current process of separating and isolating clotting factors from plasma helps reduce viral transmission risk.1
In addition, KOĀTE uses 2 independent, dedicated viral inactivation steps (steps 8 and 9) that are specifically designed to inactivate or eliminate viruses.2
Note, because KOĀTE is made from human plasma, it carries a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents.
Kedrion Biopharma is QSEAL-Certified.
The Plasma Protein Therapeutics Association's voluntary standards program provides global leadership for the plasma protein industry's goal of continuous improvement with a focus on safety and quality from the donor to the patient.4
Click on each step to learn more.
The strict safety standards for KOĀTE begin with the careful screening of donors at FDA-licensed plasma donation centers here in the US. Only qualified donors provide plasma for KOĀTE.5
Serology testing indicates whether a donor has been exposed to a virus and could pass it on to others.1
Nucleic Acid Amplification Testing (NAT) detects the genetic material of viruses in plasma.1
Each unit of donated plasma receives a barcode linking it back to a particular donor so the plasma can be identified and tracked throughout the manufacturing process.
Every unit of donated plasma is held in quarantine for at least 60 days after the donation. This allows the plasma to be identified and destroyed based on strict donor qualifications/behavior or test results.4
Plasma donations that have passed previous tests are combined into 3,000- to 10,000-unit manufacturing pools to undergo further NAT testing.4
Cleared pools of plasma undergo a fractionation process to separate and isolate the FVIII/VWF complex that makes up KOĀTE from other unwanted materials in the plasma.1,2
The purified FVIII/VWF complex undergoes a solvent/detergent treatment that inactivates enveloped viruses such as2:
- HIV: human immunodeficiency virus
- HBV: hepatitis B virus
- HCV: hepatitis C virus
- WNV: West Nile virus
The solvent and detergent are then removed.
The purified FVIII/VWF complex is freeze-dried in its final container and then heated to 80°C (176°F) for 72 hours. This final step inactivates both enveloped and non-enveloped viruses such as2:
- HAV: hepatitis A virus
- B19V: human parvovirus B19
To ensure the effectiveness of KOĀTE’s manufacturing process and the ability of steps 8 and 9 to inactivate viruses, the entire process is validated through FDA-reviewed tests.
Once manufacturing is complete, there is a process in place to diligently and intensely investigate any reports of adverse reactions or potential virus transmission.
There have been ZERO documented cases of viral transmission associated with KOĀTE’s current manufacturing process.3
References: 1. Klamroth R, Groner A, Simon TL. Pathogen inactivation and removal methods for plasma-derived clotting factor concentrates. Transfusion. 2014;54:1406-17. 2. KOĀTE [prescribing information]. Fort Lee, NJ. Kedrion Biopharma Inc. 2018. 3. Data on File. 4. Quality Standards of Excellence, Assurance and Leadership (QSEAL). PPTA website. https://www.pptaglobal.org/safety-quality/standards/qseal. Accessed June 5, 2018. 5. International Quality Plasma Program (IQPP). PPTA website. https://www.pptaglobal.org/safetyquality/standards/iqpp#Donor. Accessed June 5, 2018.