-A study confirms that the frequency of donation of Source Plasma as regulated by the US FDA does not harm the health and well-being of the donor
ANNAPOLIS, Md., Aug. 26, 2023 /PRNewswire/ — The Plasma Protein Therapeutics Association (PPTA) announced the publication of its research study evaluating the “Effects of Donation Frequency on the Health of Source Plasma in the USA.” in Transfusion magazine. The results of this peer-reviewed study indicate that, based on donor self-reporting, compensated donations of Source Plasma at the frequencies and volumes allowed by the US FDA are consistent with maintaining the health and safety of the donors.
Source Plasma, or the 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 the blood, which are then returned to the donor. . Plasma is the starting material for the manufacture of life-saving plasma-derived medicines (PDMPs) that are essential to treat a variety of rare, serious and chronic conditions, often of genetic origin.
This PPTA-sponsored research was designed to assess the impact of US donation frequency on donor self-reported health and well-being. A total of 5,608 donors from 14 US donation centers 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 assesses eight functional domains of health, such as the ability to perform 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 periods of time. The results of both surveys showed that there were no statistically significant differences in SF-36v2 scores between any of the donor frequency groups, compared to new donors. Cough, cold, occasional fatigue, and sore throat were the most reported health conditions or symptoms, but there were no clear differences between groups by gender or frequency. Additionally, the data shows that, compared to the general population, Source Plasma donors have comparable or better self-reported health.
“Donor health remains paramount 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 demonstrating that repeat plasma donation is safe and does not adversely affect the health of the donor,” said Anita Brikman, president and CEO of PPTA.
About PPTA
The Plasma Protein Therapeutics Association (PPTA) is a dynamic trade association representing 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 manufacturers of life-saving plasma protein therapies. Our members produce approximately 80% of plasma protein therapies in the US and 60% of those made in Europe. PPTA works globally to: advocate for access and affordability of therapies for patients; engage in constructive dialogue with regulatory agencies; and collaborate with patient advocacy organizations.
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