Study Confirms that Frequency of Source Plasma Donation as Regulated by U.S. FDA Does Not Impair Donor Health and Well-Being

ANNAPOLIS, Md., Aug. 25, 2023 /PRNewswire/ -- The Plasma Protein Therapeutics Association (PPTA) announced the publication of its research study assessing the "Effects of Donation Frequency on U.S. Source Plasma Donor Health" in the Transfusion journal. The results of this peer-reviewed study indicate that, based on donor self-reporting, compensated Source Plasma donations at U.S. FDA-permitted frequencies and volumes are consistent with maintaining donor health and safety.

Source Plasma, or plasma used for manufacturing/fractionation, is collected from healthy, volunteer donors through a process called plasmapheresis, during which plasma is separated from red blood cells and other cellular components of blood, which are then returned to the donor. Plasma is the starting material for manufacturing lifesaving, plasma-derived medicinal products (PDMPs) that are essential to treat a range of rare, serious, and chronic conditions, often genetic in origin.

This PPTA-sponsored research was designed to assess the impact of U.S. donation frequency on donor self-reported health and well-being. It involved 5,608 donors from 14 U.S. donation centers, who were enrolled in a cross-sectional study to assess self-reported health-related quality of life (HRQoL) and well-being. Donors were divided by sex and assigned to four different groups, based on the frequency of their donations during the 12 months prior to enrollment in the study.

Donors were assessed using the SF-36v2^® Health Survey (SF-36v2), which appraises eight functional domains of health, such as the ability to engage in physical activity and mental well-being, as examples. An additional survey evaluated the frequency of various health conditions that may be associated with impaired immune function over different time periods. The results from both surveys showed there were no statistically significant differences in SF-36v2 scores between any of the donor frequency groups, compared with new donors. Cough, cold, occasional fatigue and sore throat were the most reported health conditions or symptoms, but there was no clear difference among sex or frequency groups. Additionally, data show that when compared with the general population, Source Plasma donors have comparable or better self-reported health.

"Donor health remains of paramount importance to the plasma-derived therapies industry. Without plasma donors, there would be no plasma-derived medicines. This research adds to the body of scientific evidence that shows repeat plasma donation is safe and does not adversely impact donor health," said Anita Brikman, PPTA President and CEO.

About PPTA

The Plasma Protein Therapeutics Association (PPTA) is a dynamic trade association that represents a unique sector of the biologics and biotechnology industry. PPTA represents more than 1,000 human plasma collection centers in North America and Europe, as well as the manufacturers of lifesaving plasma protein therapies. Our members produce approximately 80% of the plasma protein therapies in the U.S. and 60% of those manufactured in Europe. PPTA works globally to: advocate for access to and affordability of therapies for patients; engage in constructive dialogue with regulatory agencies; and collaborate with patient advocacy organizations.

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