Glossary

Using organisms or biologically derived macromolecules to carry out enzymatic reactions or to manufacture products.

The creation of a product utilizing a living organism.

Equipment, systems, or facilities used in the creation of products utilizing living organisms

The gross and microscopic examination of tissues or cells removed from a living patient for the purpose of diagnosis or prognosis of disease, or for the confirmation of normal conditions.

Water that is sterile, pyrogen free and has a total solids content of less than 1 ppm.

A closed system (flask, roller bottle, tank, vessel, or other container) capable of supporting the growth of cells, mammalian or bacterial, in a culture medium in which a biological transformation takes place. A bacterial reaction usually is said to take place in a fermenter, and cell culture in a bioreactor.

The use of microorganisms to remedy environmental problems, rendering hazardous wastes nonhazardous.

Basic Input Output System

The US Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) in their Biosafety in Microbiological and Biomedical Laboratories – Fifth Edition – 2007, Section IV, Laboratory Biosafety Level Criteria, defines the essential elements of the four biosafety levels for activities involving infectious microorganisms and laboratory animals. The levels are designated in ascending order, by degree of protection provided to personnel, the environment, and the community. Standard microbiological practices are common to all laboratories. Special microbiological practices enhance worker safety, environmental protection, and address the risk of handling agents requiring increasing levels of containment.The four biosafety levels for operations performed with infectious agents are:1.BSL-1: Biosafety Level 1 is suitable for work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans, and present minimal potential hazard to laboratory personnel and the environment. BSL-1 laboratories are not necessarily separated from the general traffic patterns in the building. Work is typically conducted on open bench tops using standard microbiological practices as determined by appropriate risk assessment. Laboratory personnel must have specific training in the procedures conducted in the laboratory and must be supervised by a scientist with training in microbiology or a related science.2.BSL-2: Biosafety Level 2 builds upon BSL-1. BSL-2 is suitable for work involving agents that pose moderate hazards to personnel and the environment. It differs from BSL-1 in that (1) laboratory personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures; (2) access to the laboratory is restricted when work is being conducted; and (3) all procedures in which infectious aerosols or splashes may be created are conducted in BSCs or other physical containment equipment.3.BSL-3: Biosafety Level 3 is applicable to clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through inhalation route exposure. Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents, and must be supervised by scientists competent in handling infectious agents and associated procedures. All procedures involving the manipulation of infectious materials must be conducted within BSCs, other physical containment devices, or by personnel wearing appropriate personal protective equipment.4.BSL4: Biosafety Level 4 is required for work with dangerous and exotic agents that pose a high individual risk of life-threatening disease, aerosol transmission, or related agent with unknown risk of transmission. Agents with a close or identical antigenic relationship to agents requiring BSL-4 containment must be handled at this level until sufficient data are obtained to confirm continued work at this level, or re-designate the level. Laboratory staff must have specific and thorough training in handling extremely hazardous infectious agents. Laboratory staff must understand the primary and secondary containment functions of standard and special practices, containment equipment, and laboratory design characteristics. All laboratory staff and supervisors must be competent in handling agents and procedures requiring BSL-4 containment. Access to the laboratory is controlled by the laboratory supervisor in accordance with institutional policies.There are two models for BSL-4 laboratories:(1) A cabinet laboratory where all the handling of agents must be performed in a Class III BSC.(2) A Suit laboratory where personnel must wear a positive pressure protective suit.BSL-4 Cabinet and Suit Laboratories have special engineering and design features to prevent microorganisms from being disseminated into the environment.

The National Institutes of Health (NIH) specifies physical containment levels and defines Biosafety Levels in their “Guidelines for Research Involving Recombinant DNA Molecules” – Appendix G – May 1999. There are four biosafety levels for operations performed with infectious agents.1.BL-1: practices, safety equipment, and facilities appropriate for work performed with defined and characterized strains of viable microorganisms not known to cause disease in healthy adult humans. The Basic Laboratory. This laboratory provides general space in which work is done with viable agents, which are not associated with disease in healthy adults. Conventional laboratory designs are adequate. Areas known to be source of general contamination, such as animal rooms and waste staging areas, should not be adjacent to patient care activities. Public areas and general offices to which non-laboratory staffs require frequent access should be separated from spaces, which primarily support laboratory functions. 2.BL-2: practices, safety equipment, and facilities appropriate for work performed with a broad spectrum of moderate risk agents present and associated with human disease of varying severity. The Basic Laboratory. This laboratory provides general space in which work is done with viable agents, which are not associated with disease in healthy adults. Conventional laboratory designs are adequate. Areas known to be source of general contamination, such as animal rooms and waste staging areas, should not be adjacent to patient care activities. Public areas and general offices to which non-laboratory staffs require frequent access should be separated from spaces, which primarily support laboratory functions.3.BL-3: practices, safety equipment, and facilities appropriate for work performed with indigenous or exotic agents where the potential for infection by aerosols is real and the disease may have serious or lethal consequences. Just walking through the area and breathing the air could infect one. The Containment Laboratory. This laboratory has special engineering features that make it possible for laboratory workers to handle hazardous materials without endangering themselves, the community or the environment. The unique feature, which distinguish this laboratory from the basic laboratory, are the provisions for access control and a specialized ventilation system. The containment laboratory may be an entire building, a single module, or complex of modules within a building. In all cases, a controlled access zone from areas open to the public separates the laboratory. 4.BL4: practices, safety equipment, and facilities appropriate for work performed with dangerous and exotic agents that pose a high individual risk of life-threatening disease. Exposure to the skin could cause infection. The Maximum Containment Laboratory. This laboratory has special engineering and containment features that allow activities involving infectious agents that are extremely hazardous to the laboratory worker or that may cause serious epidemic disease to be conducted safely. Although the maximum containment laboratory is generally a separate building, it can be constructed as an isolated area within the building. The laboratory’s distinguishing characteristic is that it has secondary barriers to prevent hazardous materials from escaping into the environment. Such barriers include sealed openings into the laboratory, airlocks or liquid disinfectant barriers, a clothing-change and shower room contiguous to the laboratory, a double door autoclave, a bio-waste treatment system, and a treatment system to decontaminate exhaust air.

A biologic medicine in which its active substance is similar, but not identical to, the one in a biological medicine that has already been authorized (biological reference medicine). A follow-on version of an original biological medicine, and designed to treat the same disease(s) as the original product.

The part of the earth and its atmosphere that is inhabited by living organisms.

The production, by biological synthesis or degradation, of compounds by a living organism (e.g. amino acid synthesis, nucleotide synthesis).

An industry that creates, develops, and markets a variety of techniques that use living organisms, or substances from those organisms, to make or modify a product by microbial and biochemical processes. A common misconception is that biotechnology refers only to recombinant DNA or gene splicing work. Recombinant DNA is only one of the many techniques used to derive products for organisms, plants, and parts of both for the biotechnology industry. A list of areas covered by the term biotechnology would more properly include: plant tissue culture, cell fusion techniques (especially for the production of monoclonal antibodies), enzyme systems, plant breeding, meristem culture, fermentation, and others.

A process of applying genetic engineering (recombinant DNA), hybrid (monoclonal antibody), hybridization (gene probes), bioelectric, etc. to commercial applications in pharmaceutical, chemical, medical diagnostic device, food, animal and plant industries.

1. The use of biological processes or organisms for the production of materials and services of benefit to humankind. Biotechnology includes the use of techniques for the improvement of the characteristics of economically important plants and animals and for the development of micro-organisms to act on the environment.2. The scientific manipulation of living organisms, especially at the molecular genetic level, to produce new products, such as hormones, vaccines or monoclonal antibodies.

Large molecules that are not manufactured by means of chemical synthesis but rather produced by means of fermentation and/or recovery, sourced from genetically engineered products.

Contaminant substance that is obnoxious to the development and preservation of the life of organisms, microorganisms, tissues or individual cells.

The conversion of one chemical or material into another using a biological catalyst: a near synonym is biocatalysis, and hence the catalyst used is called a biocatalyst. Usually the catalyst is an enzyme, or a whole, dead microorganism that contains an enzyme or several enzymes.

Waste biological material from bioprocessing.

The inactivation or “killing” of biological organisms using heat or chemicals. This step is done at the end of the processing to ensure that there are no living organisms remaining in the effluent that is sent to the sanitary sewer system. Heat is usually applied at 130ºC (266ºF) for mammalian cells. Chemicals used include caustic or acid.

International Bureau of Weights and Measures (Bureau International des Poids et Mesures)

Bureau International des Poids et Mesures

Building Integrated Photovoltaics

The British Institute of Regulatory Affairs