Safety
Medicines whose ingredients include human tissue or other biological substances are called ‘biologics’. Plasma protein products are among the safest biologics-based pharmaceutical products.
According to the Canadian Hemophilia Society and Health Canada not a single case of HIV, hepatitis B or C has been transmitted by a plasma product in the last 20-plus years.
Through rigorous screening and testing of donors and advanced manufacturing, Grifols is doing its part to ensure we maintain this safety record.
Donor Precautions
We put our donors through four layers of screening to ensure that only the healthiest people donate:
- On every visit, the donor must meet the basic donor eligibility checklist requirements.
- On every visit, the donor must pass the health history and current health review criteria on the donor questionnaire.
- On the first visit and every 16 weeks the donor must pass extensive screening including serum protein evaluation.
- On every visit, the donor is tested for the specific transmissible disease markers using the latest technologies.
Grifols also checks donors against the National Donor Deferral Registry, which tracks those who seeking to donate who test positive for HIV, hepatitis B or C.
Product Safety
Only plasma from qualified donors is used for further manufacturing of plasma-derived therapies.
Qualified donors are those who have been deemed eligible to donate twice within a 6 months period and tested negative for transmissible diseases including HIV and hepatitis B and C each time.
Our donor screening does not stop on the day of donation. Every batch of donated plasma is held for at least 60 days in quarantine in case we receive delayed information that might disqualify the donor.
For example, if a regular donor tests positive for a transmissible disease on one of his latest visit, all of the plasma he has donated previously and is quarantined is removed from the production batch.
During the manufacturing process, the plasma is also subject to viral inactivation and filtration steps.
Donor Selection Criteria and Product Quality
