Committed to Plasma Safety

2 independent, dedicated viral inactivation steps1

0 documented cases of viral transmission associated with KOĀTE's current manufacturing process.2

Plasma Safety and COVID-19

COVID-19 is caused by SARS-CoV-2, a single strand enveloped RNA virus.3

KOĀTE uses 2 independent, dedicated viral inactivation steps that are proven to inactivate or eliminate viruses.1 In addition, the Dry Heat Treatment used in the manufacturing of KOĀTE inactivates enveloped viruses, or those covered with a "fatty" outer coat.1,3

Kedrion Biopharma is QSEAL-Certifed.4

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

Because KOĀTE is made from human plasma, it carries a risk opf transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents.

Manufacturing Process

A Donor Selection

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

B Donation Testing: Serology

Serology is a process that tests donated plasma for "markers" that indicate a donor has been exposed to a virus and could pass it on to others.6,7

C Donation Testing: NAT

Nucleic Acid Amplification Testing (NAT) detects the genetic material of viruses in plasma. NAT is very sensitive and can detect viruses before the donor has any symptoms of an infection.6,7

D Plasma Inventory Management

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.

E Up to 60-Day Hold

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.6,7

F Manufacturing Pool Testing

Plasma donations that have passed previous tests are combined into the manufacturing pools to undergo further NAT testing.6

G KOĀTE Purification

Cleared pools of plasma undergo a fractionation process to separate and isolate the FVIII and co-purified VWF that makes up KOĀTE from other unwanted materials in the plasma.2

H Solvent/Detergent Treatment

KOĀTE undergoes a solvent/detergent treatment that inactivates enveloped viruses such as2: HIV – human immunodeficiency virus; HBV – hepatitis B virus; HCV – hepatitis C virus, and WNV – West Nile virus.

The solvent and detergent are then removed.

I  80°C Dry Heat Treatment

Heat treatment at 80°C for 72 hours has the capacity to inactivate enveloped viruses (such as HIV and HCV) as well as nonenveloped viruses (such as HAV and B19V).2

J Validation

To ensure the effectiveness of KOĀTE's manufacturing process and the ability to inactivate viruses (H, I), the entire process is validated through FDA-reviewed tests.2,8

K Pharmacovigilance

Once manufacturing is complete, there is a process in place to diligently and intensely investigate any reports of adverse reactions or potential virus transmission.