Blood-based products: Why ethical collection practices make a material difference

With the rise of precision medicine, researchers have an increasing need for leukopacks and other blood-based products with which to run tests and advance treatment studies. This has created an analogous demand for raw material—and a rise of biomaterial donor sites to supply it.

They are not all the same.

Historically, blood donor centers have been located in downtown metropolitan areas. Often their donor base is comprised of people with a history of alcohol or substance abuse, people whose blood may be one of the few assets they have. Little is known about their overall medical history or their current health; such donors, should not, in truth, be considered for blood donation. Their donations are motivated by profit—a fundamental need for the cash a donation generates—and burdened by economic pressure. The donation centers themselves may be more factory than clinic, a place to process donors and their blood. The resultant stressors may have a significant impact on the end product, with activation of stress response markers for example.

There is an alternative. New donation centers are emerging in suburban areas, using alliances with primary care physicians and specialists to both recruit and screen donors. Such centers can provide highly detailed donor information, including height, weight, and use of nicotine, alcohol and prescription medications and vaccination status. The active physician relationship helps verify that information, determine overall health, and add rigorous screening that ensures that donors are free from a broad range of viral infections (other than the one being researched).

Precision gets its raw materials from sites that recruit exclusively through allied physicians, having them identify patients who have the requested viral or chronic disease markers, and whom the physician feels are healthy enough to donate. Donors are sometimes paid, but that is not their primary motivation; they want to contribute to science—or to advance the search for a treatment for their own disease. Collections are done in a strict Independent Review Board atmosphere. Uniquely, some of these sites also collect and process samples the same day, resulting in the ability to run assays with more labile cell types.

Their true differentiator is in the treatment of the donors. Donations are made in private collection rooms, where donors can rest comfortably. The atmosphere is calm and quiet; donors even have their own televisions or ipads. Relationships with the staff are one-on-one. It is the antithesis of the large, open collections rooms at more typical centers. We believe firmly that it makes a tangible difference, especially for leukapheresis.

A less stressful donation leads to better leucocyte recovery, and leukopacks containing healthy, viable cells that are not over expressing stress response markers.

So, are traditional collection methods unethical? Not exactly; donation centers aren’t coercing donors or taking donations under false pretenses. Yet comparatively speaking, the new donation model—with generally healthier, rigorously screened, physician-recruited donors, whose motivation is more humanitarian than economic and whose experience is more personalized and calmer—may, in fact, produce a better end-product too. That could make a difference to science, and to the lives of thousands of patients worldwide.

About The Author

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Deborah Phippard

Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Led biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy.

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