Glossary

The fundamental unit of life. The living tissue of almost every organism is composed of these fundamental living units. Unicellular organisms, such as yeast or a bacterium, perform all life functions within the one cell. In a higher organism, a multicellular organism, entire populations of cells may be designated a particular task. The cells of muscle tissue, for example, are specialized for movement.

(ICH Q5D) A cell bank is a collection of appropriate containers, whose contents are of uniform composition, stored under defined conditions. Each container represents an aliquot of a single pool of cells.

A system whereby successive final lots (batches) of a product are manufactured by culture in cells derived from the same master cell bank (master cell seed). A number of containers from the master cell bank master cell seed) are used to prepare a working cell bank (working cell seed). The cell-bank system (cell-system) is validated for the highest passage level or number of population doublings beyond that achieved during routine production.

The in vitro propagation of cells removed from organisms in a laboratory environment with strict sterility, temperature, and nutrient requirements; also used to refer to any particular individual sample. Usually, cell culture takes place in a bioreactor.

The process whereby descendants of a common parental cell achieve and maintain specialization of structure and function. Muscle cells become muscle cells and bone cells develop. In humans all the different types of cells differentiate from the simple sperm and egg.

The fusing together of two or more cells to become a single cell. This technique has had important consequences in immunology, developmental biology, and genetics. For example, monoclonal antibodies are produced by fusing a spleen cell (producing an antibody specific for the antigen of interest) with a mouse myeloma cell to produce a hybridoma which has an indefinitely long life because of the myeloma component and which secretes a specific antibody. When a human cell is fused with a mouse cell, the human chromosomes are progressively lost from the resultant hybrid and by correlating the presence of proteins in the hybrid with the presence of particular human chromosomes, genes can be assigned to individual chromosomes.

(ICH Q5D) Type of cell population which originates by serial subculture of a primary cell population, which can be banked.

Cultures of cells that have a high capacity for multiplication in vitro. In diploid cell lines, the cells have essentially the same characteristics as those of the tissue of origin. In continuous cell lines, the cells are able to multiply indefinitely in culture and may be obtained from healthy or tumoral tissue. Some continuous cell lines have oncogenic potential under certain conditions

The number of cells per unit volume of a culture.

A strain of cells having specific properties or markers derived from a primary culture of a cell line by selection or cloning. The selected properties must persist during subsequent cultivation. Also known as Single-Cell Line.

(ICH Q5A (R1)) Cells used to manufacture product.

Acquired immunity in which T lymphocytes play a predominant role. Development of the thymus in early life is critical to the proper development and functioning of cell-mediated immunity.

Products that introduce genetic material into the body to replace faulty or missing genetic material, thus treating or curing a disease or abnormal medical condition. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.

A complex carbohydrate composed of long, unbranched chains of betaglucose ((1.4)-linked-beta;-D-glucose) molecules, which contribute to the structural framework of plant cell walls. It comprises 40% to 55% by weight of the plant cell wall.

A polymer of six-carbon sugars found in all plant matter, the most abundant biological compound on earth.

Of or pertaining to a temperature scale that registers the freezing point of water as 0°C and the boiling point as 100°C under normal atmospheric pressure. Also called “centigrade”. The designation Celsius has been official since 1948, but centigrade remains in common use.

Conveyor Equipment Manufacturers Association

Cardiac Electrophysiology and Monitoring Devices Branch (CDRH)

Comité Européen de Normalisation(European Committee for Standardization)

Comité Européen de Normalisation Electrotechnique (European Committee for Electrotechnical Standardization)

The FDA successor to the Bureau of Biologics is responsible for ensuring the safety of this nation’s entire blood supply and the products derived from it; the production and approval of safe and effective of child hood vaccines, including any future AIDS vaccines; the proper oversight of human tissue for transplantation; an adequate and safe supply of allergenic materials and anti-toxins; the safety and efficacy of biological therapeutics, including an exciting new array of biotechnology-derived products used to treat diseases such as cancer and AIDS.

The successor to the Bureau of Drugs of the FDA concerned with all SVPs (Small Volume Parenterals), LVPs (Large Volume Parenterals), and non-biological drugs.

An organization with specific expertise in a computer system that acts as a resource for evaluating technical issues associated with problems, changes, upgrades, etc. in support of the global community. The CoE may play a strong role in supporting validation.