Glossary

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.

This classification is based on responses to a series of in vivo tests for which extracts, materials and routes of administration are specified. Six Plastic Classes are defined:1.Class I – Uses a specified dosage of an extract of sample in Sodium Chloride Injection applied either intravenously or intracutaneously into a mouse or a rabbit.2.Class II – Same as Class I but in addition uses an extract of sample in 1 in 20 Solution of Alcohol in Sodium Chloride Injection applied either intravenously or intracutaneously into a mouse or a rabbit.3.Class III – Same as Class II but in addition uses an extract of sample in Polyethylene Glycol 400, and an extract of sample in Vegetable Oil, both applied either intraperitoneally or intracutaneously into a mouse.4.Class IV – Same as Class II but in addition uses an extract of sample in Vegetable Oil applied intraperitoneally or intracutaneously into a mouse or a rabbit. Also uses implant strips of sample into a rabbit.5.Class V – Same as Class II but in addition uses an extract of sample in Polyethylene Glycol 400, and an extract of sample in Vegetable Oil applied intraperitoneally or intracutaneously into a mouse or a rabbit.6.Class VI – Same as Class V but in addition uses implant strips of sample into a rabbit.These tests are designed to determine the biological response of animals to elastomerics, plastics and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test. Three tests are described:1.Systemic Injection Test – Designed to determine the systemic biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.2.Intracutaneous Test – Designed to determine the local biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.3.Implantation Test – Designed to evaluate the reaction of living tissue to the plastic and other polymers by the implantation of the sample (specimen under test) itself into animal tissue.With the exception of the Implantation Test, the procedures are based on the use of extracts that, depending on the heat resistance of the material, are prepared at one of the three standard temperatures: 50°, 70°, and 121°. Therefore, the class designation of a plastic must be accompanied by an indication of the temperature of extraction e.g., IV - 121°, which represents a class IV plastic extracted at 121°).

The majority of the primary biological reference preparations referred to in the European Pharmacopeia are the appropriate International Standards and Reference Preparations established by the World Health Organization (WHO). Because these reference materials are usually available only in limited quantities, the Commission has established Biological Reference Preparations (indicated by the abbreviation BRP) where appropriate. Where applicable, the potency of the Biological Reference Preparation is expressed in International Units. For some Biological Reference Preparations, where an international standard or reference preparation does not exist, the potency is expressed in European Pharmacopeia Units.

The US Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) in their Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets – Third Edition – September 2007, Section III, Biological Safety Cabinets, defines three classes of biological safety cabinets, which are the primary means of containment developed for working safely with infectious microorganisms. BSCs are designed to provide personnel, environmental and product protection when appropriate practices and procedures are followed. The three kinds of biological safety cabinets are designated as Class I, Class II, and Class III, and they have been developed to meet varying research and clinical needs:Class I BSC – The Class I BSC provides personnel and environmental protection, but no product protection. It is similar in air movement to a chemical fume hood, but has a HEPA filter in the exhaust system to protect the environment. In the Class I BSC, unfiltered room air is drawn across the work surface. Personnel protection is provided by its inward airflow as long as a minimum velocity of 75 linear feet per minute (lfpm) is maintained through the front opening. Because product protection is provided by the Class II BSCs, general usage of the Class I has declined. However, in many cases, Class I BSCs are used specifically to enclose equipment (e.g., centrifuges, harvesting equipment or small fermenters), or procedures with potential to generate aerosols (e.g., cage dumping, culture aeration or tissue homogenation).Class II BSC – The Class II (Types A1, A2, B1 and B2) BSCs provide personnel, environmental and product protection. Airflow is drawn into the front grille of the cabinet, providing personnel protection. In addition, the downward laminar flow of HEPA-filtered air provides product protection by minimizing the chance of cross-contamination across the work surface of the cabinet. Because cabinet exhaust air is passed through a certified HEPA filter, it is particulate-free (environmental protection), and may be recirculated to the laboratory (Type A1 and A2 BSCs) or discharged from the building via a canopy connection. Exhaust air from Types B1 and B2 BSCs must be discharged to the outdoors via a hard connection.Class III BSC – The Class III BSC was designed for work with highly infectious microbiological agents and for the conduct of hazardous operations and provides maximum protection for the environment and the worker. It is a gas-tight (no leak greater than 1x10-7 cc/sec with 1% test gas at 3 inches pressure Water Gauge) enclosure with a non-opening view window. Access for passage of materials into the cabinet is through a dunk tank, that is accessible through the cabinet floor, or double-door pass-through box (e.g., an autoclave) that can be decontaminated between uses. Reversing that process allows materials to be removed from the Class III BSC safely. Both supply and exhaust air are HEPA filtered on a Class III cabinet. Exhaust air must pass through two HEPA filters, or a HEPA filter and an air incinerator, before discharge to the outdoors. Airflow is maintained by an exhaust system exterior to the cabinet, which keeps the cabinet under negative pressure (minimum of 0.5 inches of water gauge). “The exhaust fan for the Class III cabinet is generally separate from the exhaust fans of the facility ventilation system”.

A class of drugs based on proteins that have a therapeutic effect. These large protein molecules – which are composed of more than 1,300 amino acids and can be as heavy as 150,000 g/mol (or 150 kDa) – are essentially copies or optimized versions of endogenous human proteins.(also see: Biopharmaceutical)

Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment, or cure of diseases or injuries of man.