Medicines whose ingredients include human tissue or other biological substances are called ‘biologics’. Plasma protein products are among the safest biologics-based pharmaceutical products.
Through rigorous screening and testing of donors and advanced manufacturing, Canadian Plasma Resources is doing its part to ensure we maintain this safety record.
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 a physical exam.
- On every visit, the donor is tested for the specific transmissible disease markers using the latest technologies.
Canadian Plasma Resources 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.
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 16-week 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.
Video by: Plasma Protein Therapeutics Association PPTA