Glossary

A term used to state that life arises from previously existing life, and never from things which are not alive.

An infectious agent(s), or part thereof, presenting a real or potential risk to human, other animals, or plants, directly through infection or indirectly through disruption of the environment.

Also called infectious waste or biomedical waste, is any waste containing infectious materials or potentially infectious substances such as blood. Of special concern are sharp wastes such as needles, blades, glass pipettes, and other wastes that can cause injury during handling.

(USP) A biological activity procedure that is designed to ensure that a biologics and biotechnology active ingredient has a defined biological activity of a given magnitude or within a given range.

The science of informatics as applied to biological research. Informatics is the management and analysis of data using advanced computing techniques. Bioinformatics is particularly important as an adjunct to genomics research, because of the large amount of complex data that this research generates.

A device that shoots microscopic DNA-coated particles into target cells.

A technique to insert DNA into cells. The DNA is mixed with small metal particles – usually tungsten or gold – a fraction of a micrometer across. These are then fired into a cell at very high speed. They puncture the cell and carry the DNA into the cell. Biolistics has an advantage over transfection, transduction, etc., because it can apply to any cell, or indeed to parts of a cell. Thus use of biolistics has inserted DNA into animal, plant and fungal cells, and into mitochondria inside cells. Also known as Microprojectile Bombardment)

Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.

A therapeutic agent derived from living organisms.

Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.

A substance that alters the growth or functioning of a cell. Includes hormones and compounds that affect the nervous and immune systems.

The transfer of substances from the environment to plants, animals, and humans.

(ICH Q6B) The specific ability or capacity of the product to achieve a defined biological effect. Potency is the quantitative measure of the biological activity.

Microorganisms, including genetically engineered microorganisms, cell cultures and endoparasites, whether pathogenic or not.

Once a pharmaceutical protein is isolated from the cells in which it has grown, researchers perform tests to measure the protein’s biological activity. It must maintain a certain minimal level of biological activity to be issued for animal or clinical testing, or later, for market. Researchers also test to confirm that the isolated protein is identical to the desired protein

An impediment (naturally occurring or introduced) to the infectivity and/or survival of a microbiological agent or eukaryotic cell once it has been released into the environment.

Restricting the movement of (genetically engineered) organisms by arranging barriers to prevent them from growing outside the laboratory. Biological containment can take two forms: making the organism unable to survive in the outside environment, or making the outside environment inhospitable to the organism. The latter is rarely suitable for bacteria, which, in principle, could survive almost anywhere. Thus for bacteria and yeasts, the favored approach is to mutate the genes in the organism so that they require a supply of a specific nutrient that is usually available only in the laboratory. If they get out, they then cannot grow. Making the environment unfriendly to the organism is partly a biological control, partly a physical one. Thus, some of the first genetically engineered rice strains were developed in England (which is too cold for rice to grow) and tried in the field in Arizona (where it is too dry).Biological containment may also involve the use of vector molecules and host organisms which have been genetically disabled such that they can survive only in the peculiar conditions provided by the experimenter and which are unavailable outside the laboratory.

Biological drugs (or biologics) such as insulin, penicillin, blood and blood products, vaccines, derivatives of natural substances, and extracts of living cells are grown or cultured in separate batches. Just as with beer or wine, the quality can vary considerably by batch depending on small differences in inputs. Thus, in addition to obtaining marketing approval, a biologics manufacturer previously also had to have its production methods and facilities FDA licensed. Moreover, every batch of biologics had to be FDA tested. Recent advances in biotechnology, however, have diminished the variation and made production more like that of nonbiological (or chemically synthesized) drugs. In 1995, the FDA announced simplified rules on “well-characterized” biologics, dropping manufacturing-facility licensing and batch certification in such cases. Today many biologics are treated in the same fashion as nonbiological drugs. The FDA’s rules on biologics were codified in the 1997 Modernization Act.

Impurities resulting from living matter (bacteria, virus, algae, protozoa, microfungi) and their by-products, including pyrogens (endotoxins).

Resistant microorganisms placed into or on various materials to confirm that a sterilization process is effective. They may for instance be placed within a filter in order to determine if a proposed autoclave cycle is effective. After autoclave, they are removed and culture tests are performed to see if the microorganisms were killed.

Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or injury.

(42 U.S.C. 262(a)) A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.