Plasma Safety and COVID-19
COVID-19 is caused by SARS-CoV-2, a single strand enveloped RNA virus.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
- A Donor Selection
The strict safety standards for
KOĀTEbegin 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
Cleared pools of plasma undergo a fractionation process to separate and isolate the FVIII and co-purified VWF that makes up
KOĀTEfrom other unwanted materials in the plasma.2
- H Solvent/Detergent Treatment
KOĀTEundergoes 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.