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.
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.
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.
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.
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.
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.
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.
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.
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.