or hospitals, is sold to commercial companies in the plasma fractionation industry, who in turn manufacture the plasma derivatives and sell them in the pharmaceutical market. The blood banks’ sale of their plasma to the commercial fractionator (manufacturer) may, but usually does not, involve an agreement to provide some of the manufactured derivatives back to the blood bank.
The amount of plasma obtained from whole blood is not adequate to meet the needs for raw material to produce plasma derivatives. Although plasma collection data are not readily available, an estimated 44 million liters is probably collected annually by plasmapheresis in about 650 collection centers in North America [35]. This is called source plasma, which is “the fluid portion of human blood collected by plasmapheresis and intended as the source material for further manufacturing use” [36]. Automated instruments are usually used to obtain 650–1000 mL of plasma up to twice weekly from healthy adult donors. An individual can donate up to about 100 L of plasma annually in the United States, if the plasma protein levels and other laboratory tests and physical findings remain normal.
Federally licensed plasma collection and manufacturing organizations
Organizations and facilities need FDA licenses for either plasma collection or the manufacture of derivatives from plasma, or both, depending on the activities they conduct. In the past decade, this system has undergone considerable consolidation.
Countries other than the United States have nonremunerated plasma donor programs; however, few, if any, of these provide all of the plasma needs. The US system of paid plasma donors produces about 80% of the US and 60% of the world’s plasma supply [35]. Thus, the United States is a major exporter of plasma or finished product derivatives.
Plasma collection activity
Data regarding the plasma derivative industry is proprietary and thus is not readily available. It is estimated that the US plasma and plasma products industry employs more than 10,000 people nationwide and may produce 44 million liters or more of plasma annually in the United States. Individuals who donate plasma to support the plasma derivative industry receive $20 or more per donation, and it is estimated that donors receive compensation of millions from plasma collection facilities annually. This is in contrast with whole blood donors, who donate voluntarily and do not receive compensation. Much of the plasma obtained from whole blood collected by blood banks is also used for derivative production. The volume of this plasma can be very roughly estimated as follows: approximately 12 million units of whole blood, suitable for use, is collected annually. If approximately 5 million units is used for frozen plasma and cryoprecipitate, the remaining 7 million units could produce about 1.5 million liters of plasma, which is not nearly enough to meet the need for the manufacture of derivatives.
2.6 Nongovernmental blood bank organizations
Some organizations such as the American Medical Association, the College of American Pathologists (CAP), the American College of Surgeons, or the American Society of Anesthesiologists, may from time to time take positions on blood bank– and transfusion medicine–related issues, and maintain blood bank or transfusion medicine committees. The American Society of Hematology includes transfusion medicine in its scientific programs and a section of its journal Blood. Several nongovernmental or professional organizations are devoted exclusively to blood banking and transfusion medicine.
AABB, formerly the American Association of Blood Bank
The AABB is a professional, nonprofit, scientific, and administrative association for individuals and institutions engaged in the many facets of blood transfusion and cellular therapies. AABB member facilities collect virtually all of the nation’s blood supply and transfuse more than 80% to recipients. Approximately 900 institutions (community, regional, and American Red Cross blood centers; hospital blood banks; and hospital transfusion services) and approximately 5,500 individuals are members of the AABB. Members include physicians, scientists, medical technologists, administrators, blood donor recruiters, nurses, and public‐spirited citizens. The services and programs of the AABB include inspection and accreditation, standard setting, certification of reference laboratories, operation of a rare donor file, establishment of group purchasing programs, operation of a liability insurance program for blood banks, certification of specialists (technologists) in blood banking, collection of data about the activities of the membership, conduct of regional and teleconference educational programs, provision of professional self‐assessment examinations, and conduct of donor recruitment and public education seminars. In addition, the AABB sponsors the world’s largest annual meeting, where results of new research in blood banking and transfusion medicine are presented; publishes Transfusion, the nation’s leading journal reporting scientific, technical, and medical advances in blood banking and transfusion medicine; provides legislative and regulatory assistance to members; develops a wide variety of educational materials for blood bank professionals; and supports the National Blood Foundation, which provides funds for research in transfusion medicine and blood banking.
Institutional members of the AABB are classified either as a blood center, a hospital blood bank, or a hospital transfusion service. The blood center collects blood and distributes it to several hospitals but does not transfuse blood. A hospital blood bank both collects and transfuses blood, and a hospital transfusion service transfuses but does not collect blood.
America’s Blood Centers
America’s Blood Centers (ABC) is an association of independent (that is, not American Red Cross) not‐for‐profit community blood centers established in 1962. Efforts to meet the goals of safety, quality, and efficiency in blood services are met through programs such as group purchasing of supplies, services, and liability insurance; efforts to increase volunteer blood donation; effective sharing of blood resources; strengthening of blood center management skills; training programs to ensure compliance with federal regulations; and efforts to ensure fair and balanced resolution of disputes between blood centers and the public they serve. ABC works nationally by helping to shape and influence federal and state regulations, policies, and standards of care that its membership believes are in the best interest of the donors and patients they serve. The association also works to identify and promote needed research and development in blood services; promotes information exchange between members of operational practices; and promotes new programs, policies, and ideas by conducting surveys and meetings of small working groups and by developing workable models. ABC has approximately 70 institutional members with about 600 donor centers throughout the United States that collect about 60% of the nation’s volunteer donor blood supply.
Plasma Protein Therapeutics Association
The PPTA is a trade association that advocates for the world’s source plasma collectors and producers of plasma‐based therapeutics [35]. Members of PPTA represent nearly every company in the world that collects source plasma for further manufacture. These members operate about 650 plasma collection facilities worldwide and carried about 38 million donations in the United States in 2018 [37]. The role of PPTA is to develop standards and training programs, represent the industry to the public and governments, and provide forums for discussion of new issues or technology.
2.7 World Health Organization
The WHO operates a program in Blood Safety and Clinical Technology [1–3]. The program involves developing guidelines for nationally coordinated blood programs, national blood policies, technical support, a Global Collaboration for Blood Safety program, country‐level activities to improve access to safe blood, a Quality Management Project, Guidelines on the Clinical Use of Blood, maintaining the chain of reagents and materials needed for blood
