National Hemophilia Foundation recommends recombinant factor as the standard of choice for treatment of hemophilia, but did you know that many factor products used to treat hemophilia are developed from human blood, specifically human plasma? In fact, one person with hemophilia can require up to 1,200 plasma donations for a one year’s supply of factor products. Plasma products are especially important for those undergoing immune tolerance therapy to treat inhibitors, for those with von Willebrand disease and for those in developing countries.
And plasma can come from you! Think of making a blood donation, during this time of Thanksgiving and holidays.
First, learn a bit more about plasma, Plasma is the straw-colored liquid that makes up approximately 55 percent of total blood volume. A single liter of plasma yields coagulation factors essential for blood clotting, immunoglobulins used to combat viruses and bacterial infections, and albumin, a major plasma protein that regulates blood volume and other essential functions.
In addition to treating hemophilia, plasma-derived therapies are used in everyday medicines, emergency and critical care situations, as well as preventive medicine. Albumin, for example, is used to treat burns, shock, trauma, liver conditions and cardiopulmonary illnesses; immunoglobulins are indicated for Rh incompatibility, pediatric HIV, hepatitis, and animal bites.
Plasma is an expensive raw material and represents between 40 to 60 percent of the cost of plasma-derived product production. This is due primarily to its biologic nature: plasma protein therapies are not interchangeable, have no generic variations or substitutions, and are defined as sole-source biologic products by global regulators.
Since plasma is biological in nature, complex regulation and oversight measures are in place—including collection, processing, and storage and handling requirements—to ensure plasma donor health, as well as product purity and efficacy for patients.
The majority of the world’s plasma comes from plasma donors in the U.S. Collectively, the Food and Drug Administration (FDA) and its Center for Biologics and Research (CEBR) are responsible for regulatory oversight of the U.S. blood supply. Blood collection centers are either registered or licensed by the FDA, and are held to quality standards comparable to those of pharmaceutical manufacturers. Blood establishments located outside of the U.S. that import or offer for import blood products are also required to register with the FDA.
CEBR regulates the collection of blood and blood components used for transfusions, as well as for the manufacture of pharmaceuticals derived from blood and blood components. CEBR develops and enforces quality standards, inspects blood establishments and monitors reports of errors, accidents and adverse clinical events.
Manufacturing processes begin with fractionation, followed by purification and virus inactivation. Fractionation is a time consuming and complex process that extracts, or “fractions off,” specific plasma proteins that have a proven health benefit. Fractionation requires multiple processing steps, which involve manipulating solution pH, temperature, ionic strength and alcohol concentration.
Once fractionated, plasma proteins are further subjected to virus inactivation, a complex purification processes that includes prion removal, nanofiltration, solvent/detergent treatments and incubation, to ensure sterility and purity of the final product. The complete manufacturing process, from plasma collection at a donor center to the FDA’s lot release, takes seven to 12 months.
So donate now! Next year at this time, your donation could be used to save a life!
Sponsored by ASD Healthcare.
Great Book I Just Read
Olsen sure can write a page-turner. In 1957, one of the most audacious and stunning rescues to ever take place occurred on the north face of the Eiger, one of the most notoriously difficult challenges to scale, located in the heart of the Swiss Alps. The Eiger is feared for its avalanches, fast-changing weather, and sheer facade. When two poorly-prepared Italians set off to make history by being the first Italians to scale it, they become stuck for eight days, in zero-degree weather, unable to get off the mountain. This launches an international rescue effort, that leads to surprising outcomes, including national rivalry, clashing personalities, extreme risk taking and uncertain success. Fantastic story, well told and must-reading by all mountaineers. Four/five stars.