Practices designed to reduce the risk of contamination with microorganisms.
American Society for Histocompatibility and Immunogenetics
Anti-thymocyte globulin
Securely fastened to the cellular therapy product container by means of a tie tag or comparable alternative. Any information required to be attached to a container may alternatively be affixed.
Documented systematic evaluation to determine whether approved policies or procedures have been properly implemented and are being followed.
Cells or tissue derived from a given individual intended for use in that individual.
The time at which the cellular therapy product has been determined to meet all release criteria and may leave control of the facility.
One of the two major classes of lymphocytes. The B cell antigen receptor is cell-surface immunoglobulin. Upon activation through this receptor, B cells differentiate into plasma cells and produce a soluble form of immunoglobulin (antibody).
Agent that destroys bacteria. Kills gram-negative and gram-positive bacteria unless otherwise specifically stated.
- Fungicide Kills fungi.
- Sporicide Kills spores.
- Virocide Kills viruses.
An isotonic solution of inorganic salts present in correct physiological concentrations. May also contain glucose but usually free of other organic nutrients.
Commercial name for a recombinant form of DNAse, an enzyme that digests released DNA.
Blast-forming Unit-Erythroid
A deviation from applicable regulations or from applicable standards or established specifications that relate to the prevention of communicable disease transmission or cellular therapy product contamination; or an unexpected or unforeseeable event that may relate to the transmission or potential transmission of a communicable disease or may lead to cellular therapy product contamination.
A workstation with filtered air flowing in a laminar, non-turbulent parallel to (horizontal laminar flow) or perpendicular to (vertical laminar flow) the work surface, such as to assist in aseptic handling of products. May also be referred to as a Laminar Hood or simply as a hood. Properly maintained Class I and II BSCs, when used in conjunction with good microbiological techniques, provide an effective containment system for safe manipulation of moderate and high-risk microorganisms (Biosafety Level 2 and 3 agents). Both Class I and II BSCs have inward face velocities (75-100 linear feet per minute) that provide comparable levels of containment to protect laboratory workers and the immediate environment from infectious aerosols generated within the cabinet. Class II BSCs also protect the research material itself through high-efficiency particulate air filtration (HEPA filtration) of the airflow down across the work surface (vertical laminar flow). Class III cabinets offer the maximum protection to laboratory personnel, the community, and the environment because all hazardous materials are contained in a totally enclosed, ventilated cabinet. The BSC in use in the BMT laboratories are of the Class II type.
Precursor cell of the red blood cell lineage which in vitro forms colony of cells arranged in burst forming unit.
Polymorphic surface molecules on red blood cells that are detectable (and identified) with antibodies from other individuals. Major blood group antigens include the ABO and Rh systems.
Bone marrow mononuclear cell
Blood and Marrow Transplantation
The site of hematopoiesis or the generation of the cellular elements of the blood. A source of stem cells used for transplantation of the hematopoietic system. May be referred to as marrow. Proper FACT name is Hematopoietic Progenitor Cells, Marrow or HPC-M. This terminology should be used in all relevant laboratory documents.
The white blood cell layer obtained when centrifuging whole blood or marrow components. Proper FACT name is Buffy Coat Enriched.
