This glossary contains definitions of terms commonly used in the field of blood and plasma protein therapies. These definitions may be helpful to better understand specific terminologies used throughout this website.
Provided definitions may not apply in all situations. These definitions have been collected from various official sources. Visit Sources for more information.
Albumin: the major plasma protein (approximately 60 percent of the total). Albumin stabilizes circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins. It is used during surgeries as a volume replacer.
Alpha-1 Antitrypsin Deficiency (AAT Deficiency or Alpha-1): is one of the most common serious hereditary disorders in the world and can result in life-threatening liver disease in children and adults or in lung disease in adults. It is often referred to as a genetic emphysema.
Apheresis: a method of obtaining one or more blood components by machine processing of whole blood in which the residual components of the blood are returned to the donor during or at the end of the process.
Biological product: Biological products are defined as such because they are more difficult to characterize or control than standard chemically synthesized pharmaceuticals. They include those where the starting material may be human or animal tissue or of microbiological origin. Also included are those where a complex bioassay system is required to monitor potency. The two largest groups of biologicals are blood products and vaccines. Other products include hormones, larger peptides and a miscellaneous group of tissue-derived products.
Biotechnology product: is one manufactured by recombinant DNA technology, one where genetic manipulation of cells is required, or a monoclonal antibody.
Blood: whole blood collected from a single donor and processed either for transfusion or further manufacturing.
Chronic inflammatory demyelinating polyneuropathy (CIDP): a rare autoimmune demyelinating polyneuropathy that can affect adults and children. Prolonged remission after treatment or cure is the exception. Long-term treatment is necessary, often for many years. It is sometimes referred to as chronic Guillain-Barré Syndrome.
Coagulation (or clotting) factors: a group of plasma protein substances (Factor I-XIII) contained in the plasma, which act in concert to bring about blood coagulation.
- Factor VIII: antihemophilic factor that is part of the factor VIII/von Willebrand factor complex. It is produced in the liver and acts in the intrinsic pathway of blood coagulation. It serves as a cofactor in factor X activation and this action is markedly enhanced by small amounts of thrombin.
- Factor IX: one of the proteins of the coagulation system. Deficiency of this protein causes hemophilia B.
- von Willebrand Factor: plasma glycoprotein associated with Factor VIII; important in clotting and hemostatic plug formation.
C1 esterase inhibitor deficiency: Deficiency in C1 esterase inhibitor protein, the main function of which is inhibition of the complement system, causes intermittent angioedema (swelling of face and throat) and dermal swellings.
Cryoprecipitate: a plasma component prepared from plasma, fresh-frozen, by freeze-thaw precipitation of proteins and subsequent concentration and re-suspension of the precipitated proteins in a small volume of the plasma.
Cryopreservation: prolongation of the storage life of blood components by freezing.
Fibrin: A protein involved in the clotting of blood. It is a fibrillar protein that is polymerized to form a "mesh" that forms a hemostatic plug or clot (in conjunction with platelets) over a wound site. Fibrin is made from its zymogen fibrinogen.
Fibrinogen: A soluble plasma glycoprotein that is synthesized by the liver. Processes in the coagulation cascade activate the zymogen prothrombin to the serine protease thrombin, which is responsible for converting fibrinogen into fibrin. Fibrin is then cross linked by factor XIII to form a clot.
Fibrin sealant: Plasma protein therapy used as surgical glue to control bleeding. Its main ingredient is fibrinogen.
Good Manufacturing Practice: The part of the pharmaceutical quality assurance process that ensures that products are consistently produced and to meet to the quality standards appropriate to their intended use and as required by the marketing authorization.
Guillain-Barré Syndrome (GBS): an acute disease of the peripheral nervous system in which the nerves in the arms and legs become inflamed and stop working. This causes sudden weakness leading to limb paralysis, and a loss of sensation, sometimes with pain.
Hematology: The science of the blood and blood producing organs.
Hemophilia: Hemophilia is a lifelong bleeding disorder that prevents blood from clotting properly. People with hemophilia do not have enough clotting factor, a protein in blood that controls bleeding. The severity of a person’s hemophilia depends on the amount of clotting factor that is missing.
There are two types of hemophilia: hemophilia A and hemophilia B (sometimes called Christmas disease). Hemophilia A is caused by a deficiency of factor VIII (see coagulation factors), and hemophilia B is caused by a deficiency of factor IX (see coagulation factors).
Idiopathic Thrombocytopenic Purpura (ITP): An autoimmune blood disorder. Persons affected have reduced blood platelet levels, which are essential to the clotting mechanism.
Immunoglobulins: Any of the structurally related glycoproteins that function as antibodies. They are divided into five classes (IgA, IgD, IgE, IgG, IgM) on the basis of structure and biological activity.
International Quality Plasma Program: A voluntary industry certification program for plasma collection centers that demonstrates a willingness and ability to go beyond government regulations in terms of quality and safety.
Kawasaki Disease: A childhood disease that primarily affects children under five years old. It is the leading cause of acquired heart disease in children. If not detected and treated immediately, it can result in heart damage and death.
Labile Blood Products: products that are extracted from donated blood, either directly or in one or few manufacturing steps, and that quickly lose their therapeutic potential (e.g. cell preparations and plasma).
Leukopheresis: the procedure in which blood is removed from the donor, a leukocyte (white blood cell) concentrate is separated, and the remaining formed elements and residual plasma are returned to the donor.
Manufacture: All operations of purchase of materials, production, quality control, release, storage, and distribution of pharmaceutical starting materials, and the related controls.
Multifocal motor neuropathy (MMN): A rare slow progressing asymmetrical muscle weakness and muscle atrophy with autoimmune-mediated pathogenesis.
Myasthenia gravis (MG): A rare autoimmune neuromuscular disease characterised by severe muscular exhaustion which worsens after physical exercise and improves with rest.
Plasma: the liquid portion of the blood in which the cells are suspended. Plasma may be separated from the cellular portion of a whole blood collection for therapeutic use as fresh-frozen plasma or further processed to cryoprecipitate and cryoprecipitate-depleted plasma for transfusion. It may be used for the manufacture of therapies derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled, leukocyte-depleted platelets. It may also be used for re-suspension of red cell preparations for exchange transfusion or perinatal transfusion.
Plasma, cryoprecipitate-depleted for transfusion: a plasma component prepared from a unit of plasma, fresh-frozen. It comprises the residual portion after the cryoprecipitate has been removed.
Plasma, fresh-frozen: the supernatant plasma separated from a whole blood donation or plasma collected by apheresis, frozen and stored.
Plasmapheresis: the procedure in which blood is removed from the donor, the plasma is separated from the formed elements and at least the red blood cells are returned to the donor.
Plateletpheresis: the procedure in which blood is removed from a donor, a platelet concentrate is separated, and the remaining formed elements are returned to the donor along with a portion of the residual plasma.
Primary Immunodeficiency: Inability to mount a normal immune response. Immunodeficiency can be due to a genetic disease or acquired as in AIDS due to HIV.
Quality assurance: A wide-ranging concept covering all matters that individually or collectively influence the quality of a product, including pharmaceutical starting materials. It is the totality of the arrangements made with the object of ensuring that pharmaceutical starting materials and pharmaceutical products are of the quality required for their intended use.
Quality control: All measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that raw materials, intermediates, packaging materials and finished pharmaceutical starting materials conform to established specifications for identity, strength, purity and other characteristics.
Recovered plasma: Plasma for fractionation recovered from whole blood donations and distinguished from source plasma by the mode of collection and the requirements for storage, pooling, dating and labeling of the product. Recovered plasma may be separated from individual units of whole blood by aseptic techniques up to five days after expiration or obtained from Fresh Frozen Plasma that has expired. Typically an average of 250 ml of recovered plasma is retrieved from a whole blood donation (450 ml).
Red cells: the red cells (erythrocytes responsible for the transport of oxygen in the body) from a single whole blood donation, with a large proportion of the plasma from the donation removed.
Source Plasma: the fluid portion of human blood collected by plasmapheresis and intended as starting material for further manufacturing use into life-saving therapies.
Standards: specifications and procedures applicable to an establishment or to the manufacture or release of products, which are prescribed in this subchapter or established in the biologics license application designed to insure the continued safety, purity, and potency of such products.
Starting material: A starting material is an active ingredient or an excipient intended or designated for use in the production of a product.
Unit: the volume of blood or one of its components in a suitable volume of anticoagulant obtained from a single collection of blood from one donor.
von Willebrand Disease (vWD): an inherited bleeding disorder, similar to hemophilia, but the two disorders are not the same. vWD is the most common inherited clotting disorder, affecting both men and women. (also see coagulation factors) It has been estimated that vWD affects up to 1 percent of the population. However, it is generally the least severe of the clotting disorders.
Whole Blood: blood collected from human donors for transfusion to human recipients
Blood, Plasma and Plasma Proteins: A Unique Contribution to Modern Healthcare, Edited by J. L. Valverde.