Plasma collection and manufacturing
Plasma is the foundation of our industry and the singular element that binds all of our efforts. As such, the Association's strategic goal for plasma, "ensuring the availability of safe, high quality plasma for fractionation," is of paramount importance. PPTA, together with industry works globally to address a broad range of plasma collection issues and activities and to foster the collection of high-quality plasma from healthy donors.
What is Plasma?
Plasma is the single largest component of human blood, comprising about 55%, and contains water, salts, enzymes, antibodies and other proteins.
Plasma is composed of 90% water.
Plasma is a transporting medium for cells and a variety of substances vital to the human body.
Plasma carries out a variety of functions in the body, including clotting blood, fighting diseases and other critical functions.
Source plasma is plasma that is collected from healthy, voluntary donors through a process called plasmapheresis and is used exclusively for further manufacturing into final therapies (fractionation). Source plasma donors may be compensated for their commitment.
Recovered plasma is collected through whole blood donation in which plasma is separated from its cellular components. Recovered plasma may be used for fractionation.
Importance of Donation
Only a small number of people living in the U.S. who are eligible to donate blood or source plasma actually donate. What's important is that we encourage all forms of donation from those who are eligible, so that they may contribute lifesaving blood and source plasma to those in need.
- The plasma protein therapeutics industry supports volunteerism in all of its forms, including donation. Source plasma donation and blood donation are critically important activities that contribute to saving lives. Source plasma and recovered plasma are used to produce therapies that treat people with rare, chronic diseases, and disorders such as primary immunodeficiency, hemophilia, and a genetic lung disease, as well as in the treatment of trauma, burns and shock. Whole blood donations most often are used locally in hospitals for transfusions required during surgery or other medical treatment. Visit www.donatingplasma.org for more information about becoming a source plasma donor.
- Plasma donation requires a commitment both in the amount of time for each donation and frequency of donation. Typically it takes between one and three hours to donate source plasma, and plasma can be donated twice within a seven day period. Whole blood donation takes less time—under 30 minutes—and donors donate less frequently—no more than once in eight weeks. The programs may fit into a donor's life differently at various times in the donor's life, and are equally important in helping to fulfill a vital medical need.
In more than 1,000 specialized donation centers located in the U.S., Europe, and Canada, individuals may donate plasma through a process called plasmapheresis. Plasmapheresis is a sanitary, self-contained, automated process where plasma is separated from red blood cells and other cellular components of blood which are then returned to the donor.
Source plasma collection in the U.S. is regulated by the U.S. Food and Drug Administration (FDA) and, in Europe, by the European Medicines Agency (EMA) and national regulatory authorities.
In addition to meeting regulatory requirements, PPTA member source plasma collection centers are also certified by the International Quality Plasma Program (IQPP); a rigorous, voluntary program that goes beyond regulatory requirements to help ensure donor safety and further improve the quality of source plasma used for fractionation.
Source and recovered plasma is the starting material used to manufacture lifesaving therapies. The manufacturing process is known as fractionation. Proteins are separated through this process to create a number of plasma protein therapies. This process is carried out using well-established purification methods such as precipitation, centrifugation, separation, and filtration.
Plasma is pooled and processed through a process called "fractionation" that employs time, temperature, pH, and alcohol concentrations to extract specific therapeutic proteins. These are then subjected to various purification methods and viral inactivation and removal processes to further ensure their safety and efficacy. Preparing a therapy often takes from 7-12 months between donation and final product release. This sets the production of plasma protein therapies apart from chemical pharmaceuticals and other biologics whose manufacturing processes are much more condensed and whose direct manufacturing costs are a significantly smaller portion of the overall cost.
In addition, fractionators invest substantially in research and technologies to increase the quality of proteins extracted from plasma, known as the "yield," and create new and more effective therapies.