Glossary

An RNA molecule that has been synthesized from a specific DNA template. In eukaryotes, the primary transcript produced by RNA polymerase must often be processed or modified in order to form the mature, functional mRNA, rRNA or tRNA.

The process by which the genetic information encoded in the gene, represented as a linear sequence of DNA (deoxyribonucleotides), is copied into an exactly complementary sequence of ribonucleotides known as mRNA (messenger RNA).

A protein that binds to regulatory regions and controls gene expression.

A cloning vector that allows the foreign gene or DNA sequence to be transcribed in vitro.

The full complement of activated genes, or mRNAs or transcripts, in a particular tissue at a particular time.

The process whereby a specialized cell de-differentiates and re-differentiates into a different cell type; or the process whereby and adult stem cell from a specific tissue type becomes a cell type from a very different tissue (for example a nerve stem cell differentiates into a kidney cell).

The transfer of DNA sequences from one bacterium to another via lysogenic infection by a bacteriophage (transducing phage). Genetic recombination in bacteria mediated by bacteriophage. Abortive t: Bacterial DNA is injected by a phage into a bacterium, but unable to replicate.

The acquisition of new genetic markers by addition of viral DNA to cells.

A small portable vessel used to facilitate closed transfer of a process fluid without exposure to the room environment. Typical applications are seed/inoculum transfer, small volume additions to bioreactors and other closed process systems, chromatography fraction collectors, and bulk purified product storage containers. Also know as seed canisters, pressure cans, addition cans, coke cans, “Kelly” cans.

Mechanism to effect movement of material into or out of separative enclosures while minimizing ingress or egress of unwanted matter. ISO 14644-7.

A panel to which process and/or utilities are piped that mechanically precludes erroneous cross-connections.

A panel to which process and utilities are piped, allowing cross connections between different use points. A jumper spool is used to connect the desired process/utility users and mechanically preclude erroneous connections to other lines.

A class of RNA having structures with triplet nucleotide sequences that are complementary to the triplet nucleotide coding sequences of mRNA. The role of tRNAs in protein synthesis is to bond with amino acids and transfer them to the ribosomes, where proteins are assembled according to the genetic code carried by mRNA.

Engineering Controls used to transfer materials from equipment to equipment, equipment to container or container to equipment in a controlled manner while minimizing dust emissions.

Equipment allowing the introduction and removal of material, toxic and/or sterile, with continuous protection to both operator and product.

A structured software design technique in which system structure is derived from analyzing the flow of data through the system and the transformations that must be performed on the data.

1. The uptake and establishment of DNA in a bacterium or yeast cell, in which the introduced DNA often changes the phenotype of the recipient organism.2. Conversion by various means of animal cells in tissue culture from controlled to uncontrolled cell growth. Typically through infection by a tumour virus or transfection with an oncogene.

A gene from one genome that has been incorporated into the genome of another organism. Often refers to a gene that has been introduced into a multicellular organism.

An organism formed by the insertion of foreign genetic material into the germ line cells of organisms. Recombinant DNA techniques are commonly used to produce transgenic organisms.

The alteration of a plant or animal’s DNA such that it contains a gene from another organism. There are two types of cells in animal and plants, germ line cells (the sperm and egg in animals, pollen and ovule in plants) and somatic cells (all other cells). Transgenic animals have alterations in their germ line DNA so the alterations are passed on to the offspring. That is done to produce therapeutics, to study disease, and to improve farm animals. Transgenic plants have been created for increased resistance to disease and insects as well as to make biopharmaceuticals.

Of short duration.

This data is not an electronic record under Part 11 due to its "fleeting" nature. Such data may not be stored at all; e.g., it can be a direct signal from a detector to an A/D converter. Alternatively, it can be stored temporarily in a variety of manners. For example it can reside solely in a computer's RAM, or it can be stored to a computer's virtual memory, i.e., written to hard disk in temporary files that are automatically deleted by the end of the current computer session. Transient data is unalterable by the user while it remains in memory. Transient data may be sent to a printer, processed further by the system, or transmitted to another computer system. It may be used by the system without ever being stored; e.g., as input for a feedback loop in a control system, or it could ultimately become part of an electronic record.

The substitution in DNA or RNA of one purine by another purine, or of one pyrimidine by another pyrimidine.

A device subject to section 520(l) of the act, that is, a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976.