Any conveyance or shipment (including importation and exportation) of a cellular therapy product that has been determined to meet appropriate release criteria, whether or not such conveyance or shipment is entirely intrastate.

The establishment that determines that a product meets all release criteria (or releases a product under exception) and makes a cellular therapy product available for distribution.  Includes distribution to another facility and distribution for administration.

Dimethylsulfoxide

Deoxyribonucleic acid

The genetic material of all cells and many viruses.  A polymer of nucleotides.  The monomer consists of phosphorylated 2-deoxyribose N-glycosidically linked to one of four bases adenine, cytosine, guanine or thymine.  These are linked together by 3', 5'-phosphodiester bridges.  In the Watson-Crick double-helix model two complementary strands are wound in a right handed helix and held together by hydrogen bonds between complementary base pairs.  The sequence of bases encodes genetic information.  Three major conformations exist A-DNA, B-DNA (that corresponds to the original Watson-Crick model) and Z-DNA. Z-DNA may not occur in genomic DNA.

A technique originally developed to allow viral infection of animal cells by uptake of purified viral DNA rather than by intact virus particles.  Term is now generally used to describe applications of same methodology to introduction of other kinds of genes or gene fragments into cells as DNA, such as activated oncogenes from tumors into tissue culture cells.

A person who is the source of cells or tissue for a cellular therapy product.

Diagnosis

Epstein Barr Virus

ethylene-diaminetetra-acetic-acid

Any record or document consisting of any combination of text or graphics or other data that is created, stored, modified, or transmitted in digital form by a computer.

A cellular therapy product donor who meets all donor screening and testing requirements related to transmission of infectious disease as defined by the U.S. Food and Drug Administration or non-U.S. equivalent.

Enzyme-linked immunosorbent assay

Time to achieve a sustained WBC or platelet count > a defined limit for three consecutive days.  Hallmarks for granulocytes are 500 and 1000, for platelets they are 20,000, and 50,000 in the absence of platelet transfusion within the preceding week.

Species of Herpes Virus, that binds CR2 and that causes infective mononucleosis and, in the presence of other factors, tumors such as Burkett’s lymphoma and nasopharyngeal carcinoma.  Can immortalize B-lymphocytes in vitro and in vivo.

Any unforeseen or unexpected deviations from applicable regulations, standards, or established specifications that may affect the safety, purity, or potency of a cellular therapy product.

Red blood cell (RBC).

Outside the living body.

Growth of one or more cell populations in an in vitro culture system.

A location where activities covered by these procedures and policies are performed.  Such activities include determination of donor eligibility or suitability, product collection, processing, storage, distribution, issue, and administration.