Committed to Plasma Safety

KOĀTE is manufactured from donated human plasma—the yellowish-colored, liquid portion of the blood.1 Since clotting factors like FVIII make up only a small portion of the proteins found in blood plasma, KOĀTE is made from pooled plasma collected from many US donors.1,2

The manufacturing process is designed to ensure the safety of KOĀTE.

Plasma Safety and COVID-19

COVID-19 is a highly contagious coronavirus spread by respiratory droplets. It 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. In addition, the Dry Heat Treatment used in the manufacturing of KOĀTE inactivates enveloped viruses, or those covered with a "fatty" outer coat.2

Factor Check

There have been 0 documented cases of viral transmission associated with KOĀTE's current manufacturing process4

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.

It is important to keep in mind that because KOĀTE is made from human blood, it carries a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents.

You should consult with your healthcare provider if you have any questions or concerns.