Articles
Glossary Of Terms
July 8, 2009
21 CFR 11: Code of Federal Regulations (USA) Regulates electronic records, electronic signatures, and handwritten signatures attached to electronic records submitted to the FDA.
21 CFR 210: Code of Federal Regulations (USA) Defines current good manufacturing practices in manufacturing, processing, packing, or holding of drugs in general.
21 CFR 211: Code of Federal Regulations (USA) Defines current good manufacturing practice for finished pharmaceuticals.
A
ABAC: Australian Biotechnology Advisory Council Advises the Australian government on priority issues in biotechnology, including research and development, international links, commercialization, public interest, and ethics.
accuracy: the measure of how close an experimental value is to the true value.
Acellular: without cells; an acellular vaccine contains only parts of an infectious agent, not whole cells.
active immunity: conferred when a disease or an immunization triggers production of an antibody or antitoxin (also active immunization).
ACTS: African Centre for Technology Studies An intergovernmental policy, research, and training organization in Nairobi, Kenya. Focuses on implementing the results of the 1992 United Nations Conference on Environment and Development, including Agenda 21 and the conventions on biological diversity, climate change, and desertification.
adenosine dihosphate (ADP): an ester of adenosine that cells convert into ATP to use for energy.
adenosine triphosphate (ATP): Known as the "molecular currency" of intracellular energy transfer, this nucleotide can store and transport chemical energy. It also plays a part in nucleic acid synthesis.
adjuvant: a nonantigenic substance used in a vaccine to further stimulate the immune response so that less of the actual vaccine is required.
adsorption: retention in which the solute sticks to the surface of an adsorbent.
adult immunizations: vaccines and boosters given to people older than 18 (commonly tetanus boosters, flu vaccines, and pneumonia vaccines).
adventitious agents: viruses and toxins — often infectious agents — that can accidentally contaminate a cell line.
adverse reaction: undesirable effect of a drug, vaccine, or medical device; it can be as mild as a short-term injection-site irritation or as serious as a life-threatening acute onset of anaphylaxis; also referred to as adverse event.
affinity: a measure of the attraction of one molecule to another.
affinity matrix: Ligands or "affinity tails" are inserted into packing material for use in affinity chromatography to form a matrix genetically engineered to have a specific affinity; agarose is the most common substance used.
affinity tag/affinity tail: an amino acid sequence added to a protein to enable affinity in chromatography purification.
agammaglobulinemia: a rare, inherited X chromosome-linked (recessive) disorder that affects only males, causing the body to produce little (if any) gamma globulin (IgG) and other immunoglobulins; affected individuals develop repeated infections such as sinusitis, conjunctivitis, pneumonia, bronchitis, skin infections, and chronic diarrhea.
agar: a colloidal substance (gel) extracted from certain red algaes and used in tissue culture, supplemented with nutrients as required.
agarose: a high–molecular-weight polysaccharide from seaweed used as a solidifying agent in microbial cultures (agar) and in gel electrophoresis.
agent: a microorganism or chemical substance, the presence or absence of which triggers a particular disease or infection.
aggregate: clump together.
Agrobacterium tumefaciens: A bacterial plant pathogen, commonly found in soil, that contains a plasmid used to introduce desired sections of DNA into plants.
alum: common reference to potassium aluminum sulfate dodecahydrate, a crystalline compound used in water purification, leather tanning, as an astringent, and in baking powder; it occurs in nature as the mineral kalunite; in medicine it is used to stop bleeding.
amino acid: one of 20 naturally occurring hydrocarbon molecules that in combination form proteins in living things.
amphoteric: describing something that can behave like two different things — in particular, the manner in which proteins accept or donate electrons and thus react with other molecules as an acidic or alkaline substance.
ampule: an airtight (sealed), sterile glass vessel containing a single drug dose.
anaphylactic shock, anaphylaxis: an immediate, severe, potentially life-threatening ishocki reaction to an allergen (drug substance, food, or insect sting) resulting in breathing difficulty, a drop in blood pressure, and/or unconsciousness.
anion: a negatively charged ion.
antibiotic: a drug that fights a bacterial infection.
antibodies (Abs): infection-fighting proteins that the body produces to destroy foreign microorganisms or toxins (antigens); also known as immunoglobulins.
antibody-mediated immunity (humoral immunity): immunity triggered by antibodies in blood and lymphoid tissue.
antigen (also immunogen): a foreign substance in the body (a bacterium, virus, or protein, for example) that can cause disease — and whose presence triggers an immune response (the formation of antibodies).
antigenicity: the relative ability of a substance to function as an antigen.
antiidiotypic antibodies: monoclonal antibodies that induce (mimic) an immune response to a similar or identical antigen (such as is present on a tumor, for example, in development of a cancer vaccine).
antimicrobial agents: substances such as antibacterial, antiviral, antifungal, and antiparasitic drugs that kill disease-causing organisms.
antiserum: serum containing antibodies (developed through immunization or infection); monovalent antisera are specific for one antigen, and polyvalent antisera apply to more than one.
APHIS: Animal and Plant Health Inspection Service (USA) Division of the U.S. Department of Agriculture that oversees protection of animal and plant resources, including transgenics.
apoptosis: describes the molecular and morphological changes that characterize controlled cellular self-destruction, often called "programmed cell death".
applied epidemiology: the study of the frequency and distribution of disease in human populations as applied to public health practices.
archaea: prokaryotic organisms evolutionarily distinct from bacteria; their gene expression pattern (transcription and translation) is more like the eukaryotic pattern.
arm: in clinical trials, one group of participants (an iarmi of the trial) receives one treatment (drug) while another arm receives a different treatment (placebo).
aromatic rings: hydrocarbons (also called arenes) with molecular structure incorporating one or more sets of six carbon atoms in ring formation(s); called "aromatic" hydrocarbons before the molecular structure was understood because of their shared characteristic of intense smell.
assay: a test for measuring a biological response or for determining such characteristics as composition, activity, purity, and weight.
asymptomatic: showing no signs of a disease or infection.
attack rate: the measure of disease incidence observed in a small population sample over a short time — during an epidemic, for example.
attenuated vaccines: a disease-causing virus is weakened (attenuated) by chemicals, aging, or nutrient deprivation to trigger a strong immune response without being able to cause the disease itself.
autism: a disorder more common in boys than girls, with behavior ranging from mild to severe, that adversely affects the brainis normal development of social and communication skills and can include impaired verbal and nonverbal communication and restricted and repetitive behavior patterns.
autologous: derived from the same person; people facing surgery can bank their own blood for their use as an autologous donation; or a person might receive an autologous skin graft from another part of his or her body.
B
Bacillus subtilis: a microbe commonly found in soil and vegetation, normally considered nonpathogenic, sometimes used in recombinant microbial fermentation.
bacterium (plural, bacteria): a single-celled, microscopic organism that reproduces by cell division, usually has a cell wall, and has no distinct cellular nucleus; some bacteria cause disease, whereas others are beneficial (aiding in digestion, for example).
baculovirus: a class of insect virus used as vectors for recombinant protein expression in insects.
batch mode: the most commonly used type of fermentation, in which microbes are added to a sterile nutrient broth and allowed to ferment without the addition of further nutrients (except oxygen).
BBSRC: Biotechnology and Biological Sciences Research Council (UK) Funding agency that distributes money from the governmentis Office of Science and Technology to universities and institutes throughout the United Kingdom for academic research and training in the biosciences.
BCH: Biosafety Clearing-House (UN) Established by Article 20 of the Cartagena Protocol on Biosafety to facilitate the exchange of scientific, technical, environmental, and legal information on (and experience with) modified organisms and to help countries implement the protocol, taking into account the special needs of developing countries. A project of the United Nationsi Convention on Biological Diversity.
BIA: BioIndustry Association (UK) Trade association for innovative enterprises in the United Kingdomis bioscience sector, advocates biotech to audiences from patient groups to regional, national, and pan-European governments.
big pharma: the top tier of pharmaceutical companies worldwide in terms of revenue and market influence ? often listed in the form of itop 10i lists, and for the most part concerned with development and production of small-molecules and/or synthetic drugs, both prescription and over-the-counter preparations.
BINAS: Biosafety Information Network and Advisory Service (UN) A service of the United Nations Industrial Development Organization that monitors global developments in regulatory issues in biotechnology.
BIO: Biotechnology Industry Organization US-based association that advocates the industryis positions to elected officials and regulators; informs national and international media about the industryis progress, contributions to quality of life, goals, and positions; and provides business development services such as investor and partnering meetings to member companies.
BIO-BIN: A cooperative resource on safety in biotechnology developed by OECDis BioTrack Online and UNIDOis BINAS (Web site).
Biologicals Unit (UK): Part of the Licensing Division of the MCA responsible for assessment of applications for biological and biotechnology products.
Biologics and Genetic Therapies Directorate of Health Canada: Regulates biologics and biotechnology products in the Canadian market and health system including blood and blood products, viral and bacterial vaccines, genetic therapies and diagnostics, tissues and organs, xenotransplants, radiopharmaceuticals, and reproductive technologies.
Biotechnology Australia: A collaboration of five Commonwealth government departments that helps coordinate the Australian governmentis approach to medical, agricultural, and environmental biotechnology.
biotechnology: industrial applications of genetically engineered organisms.
bivalent vaccine: a vaccine that contains two antigens.
BLA: Biologics License Application (USA) Used to submit specified biotechnology products, such as those manufactured by recombinant DNA technology and monoclonal antibody products, for marketing approval by the FDA.
bolus: concentration of injected medication.
booster (injection): a subsequent vaccine dose given to enhance the immune response to the original vaccine antigens.
booster vaccine: a subsequent vaccine dose given to enhance the immune response to the original vaccine antigens.
BPC: British Pharmacopoeia Commission Prepares new editions of the British Pharmacopoeia and its veterinary equivalent, provides advice to the UK delegation to the European Pharmacopoeia Commission, and selects and devises British approved product names. British pharmacopoeial standards are legally enforceable. Web site.
BRAVO: Biotechnology Regulatory Assistance Virtual Office (Canada) Web site (bravo.ic.gc.ca) that identifies Canadian federal and provincial regulations and many of the guidelines that currently or potentially could regulate the various aspects of biotechnology.
broth (fermentation/cell culture): the cells, nutrients, waste, and other components that make up the contents of a microbial bioreactor.
BRS: Biotechnology Regulatory Services Division (USA) Part of APHIS that oversees the importation and interstate movement of bioengineered pharmaceutical plants and infectious plant vectors as well as the release of these entities into the environment (outside of a contained facility such as a greenhouse, laboratory, or fermentor).
C
C of E: Council of Europe An intergovernmental organization founded in 1949 with its headquarters in Strasbourg, France. The Council of Europe has many links to, but should not be confused with, the European Union.
calibration: testing with standard materials to establish a relation between peak location (retention time) and identity and/or peak size and quantity.
cancer vaccine: a vaccine that would stimulate the immune system to recognize and kill cancer cells.
capacity factor: chromatographic parameter that measures the degree of retention — "The capacity factor is a measure of where the peak of interest is located with respect to the void volume, i.e., elution time of the non-retained components".
capillary: a column or tube with an inner diameter of <0.5 mm.
capsule: the coating that accumulates as loose layers with limited solubility outside the walls of many bacteria, often made of polysaccharides and referred to as "gums" or "slimes".
carbohydrate: an organic compound made of carbon, hydrogen, and oxygen; carbohydrates are monosaccharides, disaccharides, oligosaccharides, or polysaccharides depending on degree of polymerization of sugars.
carcinoma: cancer.
casein: a phosphoprotein found in milk.
caspase: intracellular cysteine protease that cleaves protein substrates when activated during apoptosis.
cation: a positively charged ion.
CBD: Convention on Biological Diversity (UN) Treaty on the conservation and sustainable use of biological diversity signed at the 1992 United Nations Conference on Environment and Development in Rio de Janeiro, Brazil. More than 150 governments signed the document at the Rio conference, and since then more than 175 countries have ratified the agreement. Member of IANB.
CBER: Center for Biologics Evaluation and Research (USA) Division of the FDA that regulates biological products, including the blood supply and products derived from it, vaccines, human tissue for transplantation, allergenic materials and anti-toxins, and biological therapeutics. (Find more detail in the iFDA to Consolidatei box.).
CBS: Canadian Biotechnology Strategy Policy orientation that defines the federal governmentis role in managing the biotechnology industry and the development and use of biotechnology in Canada.
CD, CD4+ lymphocyte, and CD8+ lymphocyte: certain cell-surface molecules are used to identify the maturity of immune cells based on their cluster of differentiation (CD); immune cells with the CD4 marker function as helper T cells to stimulate immune responses; cells with the CD8 marker may act as suppressor T cells that iturn offi antibody production after an antigen has been destroyed.
CDC: Centers for Disease Control (USA) Federal agency that develops and administers disease prevention and control, environmental health, and health promotion and education activities.
CDER: Center for Drug Evaluation and Research (USA) Division of the FDA that regulates classical pharmaceuticals, currently being reorganized to also regulate some biopharmaceuticals. (Find more detail in the iFDA to Consolidatei box.).
CDRH: Center for Devices and Radiological Health (USA) Division of the FDA responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational, or consumer products.
cellulose: a fibrous polysaccharide that is the main component in plant cell walls.
Centralised Community Procedure: (EU) Process used to submit new biologics intended for human use to the EMEA for marketing approval. Medicinal products developed by biotechnological means (Part A products), have been required to use the Centralised Procedure since its inception. Other medicinal products (Part B products) have had the option to use it. But the regulations have changed, and now all products that contain new active ingredients, derived from biotechnology or not, must follow the Centralised Procedure. (See "Submitting New Drugs and Biologics in the European Union.").
Centre BATS: Centre for Biosafety and Transdisciplinary Sustainability Management (Switzerland) Founded in 1993 by the Swiss National Science Foundation as a module of the Swiss Priority Programme Biotechnology to anticipate and address the implications of biotechnology on the economy, ecology, and society. Main activities have been developing a biosafety research program; conducting sustainability assessment studies for technology policy options; and collecting, administering, and communicating scientific knowledge on safety issues.
Certified seed: seed of a known variety produced under strict standards to maintain varietal purity.
CGIAR: Consultative Group on International Agricultural Research (UN) An association of public and private members supporting a system of 16 Future Harvest Centers that work in more than 100 countries to mobilize science to reduce hunger and poverty, improve human nutrition and health, and protect the environment. Member of IANB.
cGMPs: Current Good Manufacturing Practices A variation used to emphasize the most up-to-date regulatory guidelines for manufacturing. See GMPs.
chaotropes: substances (e.g., guanidine, sodium thiocyanide, and sodium iodide) that disrupt the molecular structure of water, macromolecules, etc. to promote activities that those structures would have inhibited.
chaperones: proteins that help other proteins fold correctly, either by preventing them from folding incorrectly or by catalyzing their correct formation, used to maximize the usable protein produced by a variety of expression systems.
chelator/chelation: Chelators bind ions of metals such as copper, zinc, or cobalt with other molecules (or parts of the same molecule) to form a highly stable structure, particularly useful in metal-chelate chromatography.
chemostat: growth chamber that maintains a bacterial culture at a particular growth rate by continually adding fresh nutrient medium while removing spent culture.
chimeric transgene: a transgene that contains sequences derived from two different genes from two different species.
chirality: describes a molecule in a chiral configuation (symmetrical with its mirror image).
chitin: a water-soluble polysaccharide polymer composed of N-acetyl-D-glucosamine found in algae, arthropod and crustacean exoskeletons, fungal cell walls, and most protozoa.
cholesterol: an animal sterol occurring in plasma membranes.
chromosome: the structure that contains the DNA and thus the inheritable characteristics of an organism; usually present loosely for gene expression, during cell division it tightens up into "supercoiled" form cilia: plural of cilium; they protrude from the surface of ciliated cells to act as an organ of locomotion or a means of inducing liquid flow around the cell; structurally identical to eukaryotic flagellum, but shorter in length.
chromatography: a technique used to separate molecules based on how they bind to various solids, liquids, or gases.
chromatofocusing: "a form of ion-exchange chromatography in which a resin is equilibrated at one pH and eluted at a second pH. The use of a weak ion-exchange resin causes a pH gradient to be formed at the solvent front owing to the buffering action of the resin. This pH gradient in turn leads to an ordering of proteins by isoelectric point. Molecules of charge sign opposite the resin bind; those of charge sign like the resin do not bind. For best resolution, the equilibration-buffer pH and the elution-buffer pH should bracket the pI of the product protein" (2).
cloning vector: a circular DNA molecule in which foreign DNA is inserted for replication in an appropriate host organism.
coccus (plural cocci): a spherical bacterium.
cohort: a group of people defined according to a common experience (such as birth year) or exposure, such as to a disease — and who, on that basis, may be chosen for/monitored as part of a clinical study.
cold chain: a series of storage and transport links (including refrigerated trucks and cold boxes) designed to keep a vaccine at the correct temperature while it travels to its destination.
column: specific to this issue's theme, a vertical, cylindrical vessel used in separation processes.
combination vaccine: two or more vaccines administered in a single dose (MMR and DTP vaccines, for example).
community immunity (also herd immunity): if a large percentage of people in a community (or animals in a population) are vaccinated against a particular disease, that disease has less chance to occur and to therefore spread to those not directly immunized — so the entire population is protected.
component vaccine:: a vaccine that contains only some components of an infectious organism to minimize the risk or occurrence of adverse reactions; the acellular pertussis vaccine is one example.
congenital: a condition present at birth, not generally referring to inherited/genetic disorders.
conjugate vaccine: a polysaccharide antigen (from, for example, tetanus or diphtheria) chemically joined with a recombinant protein for increased vaccine immunogenicity; conjugate vaccines in the childhood immunization program are Hib and MenC.
consensus conference: a forum in which laypeople are educated about a scientific discipline and create a consensus document reflecting their understanding and/or acceptance of the technology.
constitutive promoter: a DNA sequence that controls gene expression and is always available.
continuous mode: an open system of fermentation in which nutrient solution is continuously added and removed from the fermentor.
CORDIS: Community Research and Development Information Service Provides information about R&D programs and relevant matters in the European Union, including biotechnology and bioethics research.
cowpox (Variolae vaccinae): a disease of cattle, not usually lethal, that causes pus-filled blisters similar to those seen in smallpox.
CPMP BWG: Biotechnology Working Group (EU) Coordinates CPMP biotechnology activities.
CPMP: Committee for Proprietary Medicinal Products (EU) Scientific committee of the EMEA responsible for preparing the agencyis opinion on matters relating to medicinal products for human use.
crop volunteers: uncultivated seedlings or progeny from a plant.
CSM: Committee on Safety of Medicines (UK) Provides advice to the Licensing Authority on whether new active substances submitted to the MCA should be granted a marketing authorization. Also monitors the safety of marketed medicines in close association with the MCAis Post-Licensing Division to ensure that medicines meet acceptable standards of safety and efficacy.
CTD: Common Technical Document (ICH) A work in progress to provide the harmonized format and content for new product applications, already in use in the EU. Also called M4.
cytotoxic T lymphocyte (CTL): also known as killer T cells, CTLs are a type of white blood cell with surface antigen receptors that bind to fragments of antigens displayed by certain molecules of virus-infected somatic and tumor cells.
D
daughter (in cell division):: one of two genetically identical cells produced during the division of a parent cell or replication of a DNA molecule.
dead volume: empty volume in a chromatogram representing tubing between the injector and column or between column and detector; an excess can cause band broadening by diffusion.
degassing: Removal of gases from the mobile phase prior to column injection is important in HPLC to prevnt bubble formation as pressure decreases toward the bottom of the column (causing baseline spikes and noise). Degassing is achieved by heating a solvent, by helium sparging, by using vacuum (in a vacuum flask), or by on-line evacuation from a tube made of a gas-permeable substance.
dendritic cells: the most immune-stimulating cells in the human body, occurring naturally in tissues that contact the exterior environment: in the skin and the lining of nose, lungs, stomach, and intestines; they get their name from their long tentacle-like arms, called dendrites, and form from circulating monocytes; they function as antigen-presenting cells and attract invading viruses and bacteria, then cut those proteins into short, linear peptide pieces (see epitope), and carry the fragments on their surfaces (enmeshed in their tentacles) through the blood stream to lymph nodes to activate B cells, helper T cells, and CTLs; only dendritic cells can activate a helper T cell that has never before encountered a particular antigen before.
developmentally regulated promoters: a DNA sequence that controls gene expression and is available only at certain times or stages.
dextran: a linear polysaccharide of bacterial origin, made of many glucose molecules joined into a long chain.
diatomaceous earth: finely ground fossilized shells of minuscule hard-shelled algae called diatoms; also known as diatomite or kieselguhr, naturally occurring DE is roughly 86% silicon, 5% sodium, 3% magnesium, and 2% iron.
diffusion: the process by which two fluids or solutions disperse and mix when put together in a single area because of random movement of molecules by intermolecular collision.
diffusivity: the tendency of materials to spread out (mix with their surroundings), and measurements thereof.
Division of Biological Chemistry and Biologicals: (Japan) Part of NIHS responsible for quality control, inspection, and evaluation of medical agents including hormones, enzymes, proteins, biologically active high-molecular-weight compounds, radiopharmaceuticals, diagnostic agents, and biotech medicines. The division also performs biochemical studies on these drugs, makes experimental preparations of some newly developed drugs, and standardizes assay methods.
DNA: deoxyribonucleic acid, a biopolymer found primarily in the nucleus of cells. It carries genetic information for making all the structures and materials necessary for life. Its double-stranded helical molecular chain is held together by weak bonds between base pairs of nucleotides (cytosine, guanine, adenine, or thymine) linked with ribose sugar molecules.
DNA vaccine (nucleic acid vaccine): injection of a gene that codes for a specific antigen, enabling the recipient to produce that antigen directly to achieve the desired immune response.
domain (most general classification of life): a category ranked above kingdom in taxonomy; archaea and bacteria are considered by most to be distinct domains, after once being thought to be in the same kingdom (Archaebacteria); archaea were distinguished from other prokaryotes (Eubacteria) before the distinction between these groups of prokaryotes was shown to be more fundamental.
domain (of a protein): an amino acid sequence within a protein with a discrete structure or function independent of the rest of the protein.
drift: (of baseline in a chromatogram) may be caused by movement of the stationary phase into the mobile phase.
DTI: Department of Trade and Industry (UK) The Bioscience Unit advocates commercial exploitation of biotechnology by British industry, working to ensure that government, European, and international measures affecting biotechnology take full account of the implications for competitiveness. Focuses on four key areas: research and development policy and technology transfer; the regulatory environment and intellectual property rights; the financing and development of small companies; and competitiveness issues of the key biotechnology subsectors.
E
EC-Enterprise DG: European Commission Enterprise Directorate-General (EU) Promotes business competitiveness by encouraging entrepreneurship and innovation and by facilitating access to appropriate markets, giving special attention to the needs of smaller enterprises. Includes specific initiatives for pharmaceuticals (F2) and biotechnology (F3).
edible vaccines: transgenic plants developed to initiate an immune response in people who eat the raw fruits.
EDQM: European Directorate for the Quality of Medicines (C of E) Oversees a network of laboratories involved in the quality control of medicines for human and veterinary use and produces the European Pharmacopoeia.
EDTA: ethylenediaminetetraacetic acid, a common chelating agent used for enzyme deactivation and as a bacteriocide.
EFB: European Federation of Biotechnology (EU) Association of scientific institutes, societies, companies, biotechnology organizations, and personal members active or interested in biotechnology and its safe and beneficial applications. Maintains contact with the European Commissionis Research Directorate-General and disseminates information on European Commission programs and policy.
efficacy: proven ability of a drug or vaccine to produce a desired clinical effect at the optimal dose.
EFPIA: European Federation of Pharmaceutical Industriesi Associations Member associations in sixteen European countries include all of Europeis major research-based pharmaceutical companies. Provides industry input to EMEA and ICH.
electrophoresis: migration of charged molecules in an electric field through a medium such as polyacrylamide gel; usually performed for analytical purposes — but may be used to partially purify molecules for other analytical methods such as mass spectrometry, PCR, cloning, DNA sequencing, or immunoblotting.
eluate: what is recovered from a chromatography column during elution.
eluent: a substance used for recovering samples from a chromatography column (also called an elution buffer).
elution: washing out adsorbed material with a solvent of buffering agent.
EMEA: European Agency for the Evaluation of Medicinal Products (EU) Established by the European Commission to coordinate scientific resources in member states, evaluating and supervising medicinal products for human and veterinary use.
enantiomer: Two stereoisomers are enantiomers if one can be superimposed on the mirror image of the other (your left and right shoes are like enantiomers of one another).
endemic: the continual presence of a disease in a population.
endoplasmic reticulum: a network of interconnected tubules and sacs in a cell that synthesizes proteins, among other things.
enzyme-linked immunosorbent assay (ELISA): in diagnostics, a blood test to measure the concentration of antibodies to a specific antigen; an experimental technique that uses enzymes to detect the presence of specific proteins.
EPA: Environmental Protection Agency (USA) Administers (among many other things) the Toxic Substances Control Actis Biotechnology Program. (see: TSCA)
EPC: European Pharmacopoeia Commission (C of E) Produces the European Pharmacopoeia, part of the EDQM.
epidemic: occurrence of a disease within a specific area or region in excess of its normal level.
epitope: functions as an antigenic determinant a short, linear peptide sequence cut from a larger protein antigen by an antigen-presenting cell and carried to the lymph node to trigger a specific immune response.
equilibration: returning the contents of a column to a state of chemical and thermodynamic equilibrium.
ESACT: European Society for Animal Cell Technology Organization that brings together scientists, engineers, and other specialists working with animal cells to promote communication between European and international investigators and to further the development of cell systems and products derived from them.
Escherichia coli: a Gram-negative bacterium commonly found in the human colon, the most thoroughly studied of all bacteria, frequently used in recombinant bacterial fermentation.
EU: European Union An economic organization of 15 member states (Belgium, Germany, Greece, France, Italy, Luxembourg, The Netherlands, Denmark, Ireland, the United Kingdom, Spain, Portugal, Austria, Finland, and Sweden) intended to establish European citizenship; ensure freedom, security, and justice; promote economic and social progress; and assert Europeis role in the world.
eukaryote (Greek: true nucleus): a higher organism; its cells have a membrane-defined nucleus and other defined organelles.
European Commission: Represents the fifteen EU member states, working to harmonize technical requirements and procedures to achieve a single market in pharmaceuticals and allow free movement of products throughout the European Union.
EWGs: Expert Working Groups (ICH) Review the differences in requirements among the three ICH regions and develop scientific consensus required to reconcile those differences.
expression system: in genetic engineering, the cells (host organism) into which a gene is inserted to manufacture desired proteins; the gene is combined with a genetic vector (such as a virus or circular DNA molecule called a plasmid) to provide the genetic context in which it will function in the cell; that is, the gene will be expressed as the protein of interest.
F
FAO: Food and Agriculture Organization (UN) Founded in 1945 with a mandate to improve agricultural productivity and raise levels of nutrition and standards of living of rural populations. Sponsors electronic conferences on biotechnology subjects such as gene flow from genetically modified organisms. Member of IANB.
FD&C Act: Federal Food, Drug, and Cosmetic Act (USA) Legislation under which most pharmaceutical products are regulated in the United States. See also PHS Act.
FDA: Food and Drug Administration (USA) See iPharmaceutical Regulating Agencies Around the World.
fed-batch mode: fermentation in which substrate is added incrementally throughout the process.
feedstream (feed, feedstock):: the solution fed into a separation or purification process; that is, the mixture that must be divided into its separate ingredients.
filament: a bacterial cell with a length at least 10 times its width.
filamentous: in the form of long rods (filaments), much longer than wide.
flagellum (plural, flagella): a propulsive structure used by some single-celled organisms to move through liquid; bacterial and archaeal flagella are helical filaments that rotate like a screw; the eukaryotic flagella (as on sperm cells) are whip-like structures.
flash chromatography: medium-pressure chromatography (1.5–2 bar pressure forces the mobile phase through a relatively large-diameter column).
Foundation seed: produced from the original seed of a particular variety (breeder's seed) and maintained by companies or state agricultural agencies.
frits: porous elements placed at either end of a column to contain its packing (usually in the end fitting); made of stainless steel or other inert metal or plastic.
functional antibody: An antibody that binds to an antigen for an effect.
fungus (plural fungi): occurring as single-celled forms such as yeast and complex forms such as mushrooms, fungi can cause infections from mild skin infections such as ringworm and athleteis foot to life-threatening conditions such as cryptococcal meningitis, histoplasmosis, and clastomycosis.
fusion partner: the gene for a protein that can be joined to the gene for a medically useful protein to optimize production in bacterial fermentation expression systems.
G
GAMPs: Good Automated Manufacturing Practices.
GAPs: Good Agricultural Practices.
GCPs: Good Clinical Practices.
GDP: guanosine diphosphate, a chemical compound created by the actions of GTPases on GTP and essential to signal transduction in living cells genome: an organism's complete set of genetic material.
gene-flow: the movement of genes from one population to another through interbreeding.
genetic engineering: manipulating the genetic structure of an organism through technological means rather than through traditional breeding or simple cell culture to produce a therapeutic or agricultural product.
genome: an organismis complete set of genetic material.
germ cell: a "sex cell" in higher animals or plants that carries half an organism's genetic material and can combine with other germ cells to make offspring.
GLPs: Good Laboratory Practices.
glucose: a hexose (sugar containing six carbon atoms) and the prime fuel for energy generation in organisms; broken down by the metabolic process of glycolysis to form energy.
glycosylation: a posttranslational modification in which one or more carbohydrate molecules are added onto a protein.
GMPs: Good Manufacturing Practices Have been defined differently in different countries, harmonization of regulations ongoing through ICH.
Golgi apparatus: cellular organelle involved in posttranslational processing, the formation of lysosome and secretory vesicles, and the concentration and transport of cellular materials.
gradient (elution): chromatographic operation using continuous change in conditions (solvent or temperature).
GRAS: generally recognized as safe, a regulatory designation in the United States.
GTP: guanosine triposphate, a high-energy molecule required for a number of biochemical reactions, including nucleic acid and protein synthesis (formation); it is incorporated into the RNA chain during synthesis of RNA.
guanine: a purine base that is a fundamental component of nucleic acids.
guard column: a short, disposable segment of column located before the main column to trap difficult materials.
H
haptens: small parts of antigens that react specifically with an antibody but cannot stimulate antibody production on their own.
helper T cell: the chief regulatory cell of the immune response.
hemoglobin: the part of a red blood cell that carries oxygen.
heterologous: referring to certain cells and antisera derived from a different individual or species, one immunologically related but not identical (a heterologous skin graft, for example, would not come directly from its own recipient).
Hib disease (Haemophilus influenzae type b: until recently, the most common cause of death from bacterial meningitis in children, and also the cause of blood infections, pneumonia, epiglottis, and otitis media.
hollow-fiber bioreactor: cell culture system in which cells are separated from the medium using semipermeable membranes arranged into hollow fibers.
hormone-induced mammogenesis: development of the mammary gland induced by the administration of hormones (in contrast with development induced by aging or pregnancy).
host cell: a cell whose metabolism is used by a virus for growth and reproduction or into which a plasmid is introduced in recombinant DNA experiments; in bioprocessing, the cells engineered and cultured to express a protein of interest are the expression system host cells.
host factor: the intrinsic factor such as age, race, sex, or behavior that influences a personis exposure, susceptibility, or response to a causative agent.
HVAC: the heating, ventilation, and air conditioning system of a building.
hybridoma: hybrid cells made by combining tumor cells and plasma cells; the combination of normal b-lymphocytes and myeloma cells is commonly used in cell-culture expressions systems to produce monoclonal antibodies.
hydrophilic: having an affinity for water, readily absorbing moisture; either compatible with water or water soluble.
hydrophobic: insoluble in water, not readily absorbing moisture, or being adversely affected by water; either incompatible with water or having little affinity for it; often, such molecules are hydrocarbons.
hypnozoite: the form of the malaria parasite that remains in the liver and causes relapses.
hypogammaglobulinemia: a condition characterized by very low levels of all types of immunoglobulins.
I
IANB: Inter-Agency Network for Safety in Biotechnology A network of nine intergovernmental organizations (CGIAR, CBD, FAO, OECD, OIE, UNCTAD, UNIDO, WHO, and WTO) formed to exchange information and foster cooperation in biosafety regulation.
ICGEB: International Centre for Genetic Engineering and Biotechnology An autonomous international organization dedicated to advanced research and training in molecular biology and biotechnology, with special regard to the needs of the developing world.
ICH: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Brings together regulatory authorities from Europe, Japan, and the United States with experts from the pharmaceutical industry in those three regions to harmonize the scientific and technical aspects of product registration among them.
IFPMA: International Federation of Pharmaceutical Manufacturers Associations Member associations represent the research-based pharmaceutical industry and other manufacturers of prescription medicines in 56 countries. Closely associated with ICH in seeking to ensure contact with the research-based industry outside the ICH regions.
immune complex: the result of a reaction between an antigen and a specific.
immune response: the reaction of the immune system to foreign organisms.
immune serum: a serum obtained from human or animal sources and containing naturally or artificially produced antibodies to a given antigen.
immune system: cells that can destroy infected cells and cancer cells.
immunity: measured by the presence of antibodies in the blood, a natural or acquired resistance to a specific disease, whether partial or complete, specific or nonspecific, lasting or temporary.
immunodeficiency (also immunosuppression): condition in which the normal immune response is weakened or diminished from the effects of disease or drugs.
immunogenicity: the relative ability of an antigen or vaccine to elicit an immune response.
immunoglobulin (IG): when administered, an antibody that confers short-term immunity; immune gamma globulin (IGG) provides passive protection against viral infections such as hepatitis A, measles, rubella, and varicella; immune globulin (human) (IGH) is used to prevent hepatitis B.
immunomodulator: a chemical agent that modifies the immune response or the functioning of the immune system.
immunotherapy (also called biological therapy): most often referred to as a process in which allergic patients receive small, weekly doses to desensitize them to allergic substances (by developing a protective antibody, immunoglobulin G, to block the allergic reaction); in vaccine research, it refers to efforts to harness the bodyis ability to develop immune defenses against cancerous cells.
inclusion body: discrete structures present normally or abnormally within cells; examples are virons, aggregated proteins, and cellular material; recombinant proteins made by bacteria most often accumulate as inclusion bodies.
inclusion criteria: characteristics that must be met by all who participate in a clinical trial.
incubation period: a period following exposure to an infectious agent during which inapparent pathological changes culminate in the onset of disease.
IND: Investigational New Drug Application (USA) Formal means by which a company requests permission from the FDA to expose people to an experimental drug compound for clinical trials.
infectious agents: organisms (such as bacteria, viruses, and fungi) that cause.
inflammation: heat, pain, redness, and/or swelling: reactions to the release of body chemicals at a site of tissue damage; physical injury; bacterial, viral, fungal, or parasitic infection; or an allergic reaction.
inhibitor: a molecule that decreases or prevents a chemical reaction, also called negative catalysts; often used as medicines to decrease enzyme-mediated reactions; antioxidants are inhibitors, and a type of corrosion inhibitor is added to antifreeze in automobile motors.
inoculation: introducing material (a vaccine, for example) into the bodyis tissues; also introducing cells into a culture medium.
International Pharmacopoeia: (UN) Effort to unify terminology and the strengths and composition of drugs dating back to 1874 now carried out in collaboration with members of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations as well as specialists from industry and other institutions. Web site.
international transportation of disease: transmission of a disease from one country to another through an infected person, insect, or increasing ability of a pathogen to avoid the immune system.
intracellular proteins: the most ancient proteins present in all eukaryotes (multicellular organisms) are intracellular proteins, which are involved in cellular functions such as genetic transcription, DNA repair, and membrane transport.
investigational new drug (IND) application: a form submitted by a company as a request for FDAis permission to expose healthy human volunteers to an experimental drug; must be filed for each clinical trial performed, phases 1-3.
ion channels: membrane proteins that provide regulated flow of ions across cell membranes; usually selective for a specific ion type.
isocratic (elution): chromatographic operation with constant mobile phase composition.
isoelectric point (pI: the pH value at which a molecule carries no net electrical charge (below their pI, proteins carry a net positive charge; above it they carry a net negative charge).
J
joint committee on vaccination and immunization (JCVI): nondepartmental public body and statutory expert standing advisory committee that advises the secretaries of state for health in Scotland, Wales, and Northern Ireland on matters relating to communicable diseases that are potentially preventable through immunization.
JPMA: Japan Pharmaceutical Manufacturers Association Represents the major research-based pharmaceutical manufacturers in Japan. Coordinates with ICH to promote and encourage the adoption of international standards by its member companies.
K
kinesin: a motor protein that uses the energy of ATP hydrolysis to transport vesicles and particles toward the distal end of microtubules.
L
lactic acid: a byproduct of carbohydrate metabolism (anaerobic metabolism) that plays a role in several biochemical processes; produced (for example) as a result of anaerobic respiration in muscles and red blood cells when glycogen rather than oxygen is used as an energy source for respiration.
legumes: any of a large family (Leguminosae) of plants with nodules on their roots that contain nitrogen-fixing bacteria, including important food and forage plants such as peas, beans, alfalfas, and clovers.
ligand: a molecule that binds to a specific site on a protein.
limit of detection: "Detection limit is the lowest concentration of analyte in a sample that can be detected, but not necessarily quantitated, under the stated experimental conditions".
limit of quantitation: "Quantitation limit is the lowest concentration of analyte in a sample that can be determined with acceptable precision and accuracy under the stated experimental conditions".
linearity: "The linear range of detectability that obeys Beer's Law is dependent on the compound analyzed and detector used. The working sample concentration and samples tested for accuracy should be in the linear range".
lipids: fat or fatlike compounds (sterols, fatty acids, and many other substances); cannot be dissolved or mixed in water.
liposomes: microscopic, fluid-filled pouches with walls made of layers of phospholipids identical to those that make up cell membranes; used to deliver certain vaccines, enzymes, or drugs (e.g., insulin and some cancer drugs) to the body; used in the delivery of some cancer drugs to shield healthy cells from the drugsi toxicity and prevent their concentration in vulnerable tissues, lessening or eliminating common side effects; also used experimentally as a method of carrying normal genes into cells to replace defective, disease-causing genes.
live-vector vaccine: a vaccine that stimulates an immune response by using a non-disease-causing bacterium or virus to transport foreign genes into the body.
long-term memory: the immune-systemis ability to remember and defend against foreign proteins when challenged; certain vaccines are better at inducing long-term memory than others (the tetanus vaccine, for example, as compared with influenza vaccines).
lyophilization: freeze-drying.
M
M4: See CTD (Common Technical Document).
master cell bank: a culture of fully characterized cells processed together to ensure uniformity and stability and used to prepare the working cell banks for production.
MCA: Medicines Control Agency (UK) See iPharmaceutical Regulating Agencies Around the World.
MedDRA: Medical Dictionary for Regulatory Activities (ICH) Medical terminology for international electronic transmission of clinical-trial data and adverse event reporting for pre- and postmarketed compounds.
meiosis: cell division in which the daughter cells have half the number of chromosomes as the parent cell.
membrane: a lipid bilayer composed of a double layer of phospholipids and occasional proteins intertwined; may contain ion channels.
metabolites: products of metabolism; usually small molecules or protein ligands.
MHW: Ministry of Health and Welfare (Japan) Oversees National Institute of Health Sciences.
microbes: organisms too small to be seen with the naked eye — bacteria, fungi, microscopic algae, protozoa, and viruses — also called microorganisms.
microbial fermentation: the culture of bacteria, fungi, algae, protozoa, or viruses in liquid or solid media for commercial or experimental purposes.
microbore: describes LC columns with inner diameters of 0.5–2.0 mm.
microencapsulation: the process of trapping cells inside a thin, protective, often biodegradable membrane to help anchor them and protect them against harsh conditions.
microinjection: a technique by which part of one cell is injected into another cell, as DNA into ova or other cells to create transgenic animals.
mitochondrion: pl. mitochondria, cellular organelle responsible for oxidative metabolism and phosphorylation in eukaryotic cells, widely believed to have originated as a symbiotic bacterium.
monoclonal antibody (MAb): a highly specific, purified antibody that recognizes only a single epitope.
monovalent vaccine: a vaccine that recognizes only one antigen.
morbidity: exhibiting illness or disease; also the percentage of illness or disease in a population.
mortality: death; also referring to the percentage of deaths in a population.
MRFG: Mutual Recognition Facilitation Group (EU) Coordinates the operation of a decentralized mutual recognition procedure for EU member states.
mRNA: messenger ribonucleic acid that serves as a template for protein synthesis; it carries information from DNA in a cell nucleus to the ribosome sites of protein synthesis in the cell to mediate transfer of genetic information from the nucleus to ribosomes in the cytoplasm.
MSSO: Maintenance and Support Service Organisation (ICH) Group responsible for updating and maintaining MedDRA.
multidrug resistance: the ability of a pathogen to withstand a number of antimicrobial drugs — such as those that might have fought that pathogen before.
mutation: a change (usually rare and random) in the base sequence of a DNA molecule.
myosin: a protein contained in striated muscle responsible for contraction; slides along filaments of actin, generating force using ATP as its energy source.
N
NAD: nicotinamide adenine dinucleotide, a coenzyme present in most living cells; derived from the B vitamin nicotinic acid, it serves as a reductant in various etabolic processes.
NDA: New Drug Application (USA): Means by which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
necrosis: localized nonapoptotic death of cells and tissues.
NIH: National Institutes of Health (USA) Federal agency that conducts and supports medical research and dissemination of information.
NIHS: National Institute of Health Services (Japan) See iPharmaceutical Regulating Agencies Around the World.
NIST: National Institute of Standards and Technology (USA) Federal agency that develops and certifies standard reference materials for use in US industry applications.
normal phase: chromatography using a more polar stationary phase (often water) than mobile phase; not used in biotechnology, where reverse phase (more polar mobile phase) is more common peak area measures quantity; peak height measures concentration.
nuclear transfer: moving an part or all of an organism's genetic information into an unfertilized egg (whose nucleus had previously been removed); can be used for cloning or to produce transgenic animals (if the genes put into the egg have been recombined with genes from others species).
nucleoside: glycosylamines that occur when a purine or pyrimidine base is covalently attached to pentose; usually attached to ribose or 2-deoxyribose.
nucleotide: a nucleoside in which the sugar carries at least one phosphate group; nucleotides are the subunits that make up nucleic acid.
nutrient: a substance that promotes growth and healthy biological function.
O
OECD: Organisation for Economic Co-operation and Development 30 member countries and 70 other involved countries, nongovernmental organizations, and civil societies work to promote democratic government and the market economy with a focus on economic and social issues including biotechnology. Maintains Web site (Web site) that reports on efforts to harmonize biotechnology regulations among member countries.
OGTR: Office of the Gene Technology Regulator (Australia) Part of the Therapeutic Goods Administration within the Commonwealth Department of Health and Ageing. Regulates genetically modified organisms in Australia.
OIE: Office International des Epizooties Intergovernmental organization with 162 member countries intended to guarantee the transparency of animal disease status worldwide. Member of IANB.
OMCLs: Official Medicines Control Laboratories (Europe) Independent labs that control and test medicines, organized into a network by the EDQM in close collaboration with the European Union.
oocyte: immature ovum still in the ovary, becomes an ovum following meiosis.
osmosis: process that maintains equilibrium through the diffusion of water from a place of high concentration to a place of low concentration through a selectively permeable membrane.
outbreak: the spread of a disease over a short period in a limited geographic area.
P
PAI: Preapproval inspection (USA) FDA facility inspection performed after a biopharmaceutical company files a BLA or NDA.
pandemic: the spread of a disease (an epidemic) over a very large geographical area.
parenteral: a medicine that is administered intravenously or by injection; most vaccines can be administered subcutaneously (to the fatty layer immediately below the skin) or intramuscularly — but not intravenously.
PDG: Pharmacopoeial Discussion Group A forum where the pharmacopeias of Europe, Japan, and the United States discuss monographs and general methods of analysis proposed by national associations of manufacturers of pharmaceutical products for convergence and harmonization.
peptide: two or more amino acids linked together.
PERF: Pan European Regulatory Forum for Pharmaceuticals A program to encourage better cooperation among the regulators of the European pharmaceutical market.
perfusion: a fermentation process used for antibody production in which high concentrations of mammalian cells inside a chamber receive fresh growth medium continually as waste products are removed.
Ph Eur: European Pharmacopoeia (C of E) Sets out the mandatory standards for active substances, excipients, and formulated preparations together with supporting notices, method texts, and reagent specifications. Produced by the EPC. Web site.
pharmacokinetics: study of ADME processes (adsorption, distribution, metabolism, and excretion).
PhRMA: Pharmaceutical Research and Manufacturers of America Represents the research-based pharmaceutical industry in the United States.
PHS Act: Public Health Service Act (USA) Regulations under which biological products are approved for marketing. (Most biological products also meet the definition of idrugsi under the FD&C Act and are also subject to regulation under FD&C Act provisions.).
pili: elongated, proteinaceous, plasmid-encoded structures extending from the surface of Gram-negative bacteria that express conjugative plasmid; some types have been shown to be essential in conjugation.
pilot scale: an intermediate (medium-scale) bioprocessing step used to scale up from the laboratory to commercial production.
placebo: an inactive substance (or another vaccine that will elicit different immune responses from the one being tested) adminstered to some clinical trial participants to provide a basis for comparison of effects.
plant-made pharmaceuticals (PMPs): therapeutics produced in genetically modified plants.
Plantibody: antibody produced by a genetically modified plant, a trademark of Epicyte Pharmaceutical Inc.
plasmid: self-replicating hereditary material that is not part of a chromosome and is usually found in the cytoplasm of bacteria and some yeasts; plasmids can be used as vectors for introducing foreign DNA into recipient cells.
plastid: any of several types of cellular organelle found in plants and algae but not in animals or prokaryotes.
polar/nonpolar: A dipole is a pair of electric charges or magnetic poles of equal magnitude but opposite polarity (positive and negative) separated by a small distance. Polarized (polar) molecules possess this electromagnetic quality.
polyhedrin: protein some viruses use to protect themselves from ultraviolet light.
polypeptide: several amino acids linked together by a peptide bond.
polyvalent vaccine: a vaccine that contains several antigens.
posttranslational processing: enzymatic processing of a protein such as the addition of carbohydrate moieties or the removal of a signal sequence to direct a protein through a cell or organelle membrane.
potential (as in "water potential" and "cell potential"): a measure of the ability of any object or substance to draw water into itself; a cell wall that has a negative water potential will draw water into itself from an object or surroundings that has relatively positive water potential.
precision: "Precision is the measure of how close the data values are to each other for a number of measurements under the same analytical conditions. ICH has defined precision to contain three components: repeatability, intermediate precision, and reproducibility".
pre-erythrocytic: before entering red blood cells.
prevalence: the measure of people in a population affected by a disease or condition at a particular time.
prime-boost (also heterologous boosting, priming): in cases when the immune response from a single dose of a vaccine is insufficient to provide effective protection, the same antigen can be administered in two different vectors, successively: The first vector (a live-vector vaccine, for example) iprimesi the immune response with the antigen, and reexposure in the second vector (such as a recombinant subunit vaccine) iboostsi that response; contrasts with the traditional method of homologous boosting in which two or more doses of the same vaccine are given successively.
prion (derived from proteinaceous infectious particle): The causal agent of scrapie and other transmissible spongiform encephalopathies, it is a hydrophobic protein containing no nucleic acid.
prokaryote (Greek: before the nucleus): cellular microorganism in which the chromosomes are not isolated from the cytoplasm by a membrane (nucleus-free cells).
promoter: DNA sequence that initiates transcription of a gene to produce mRNA, used in genetic engineering to direct cells to manufacture a protein of interest.
prophylaxis: prevention of a disease or condition.
protease: enzyme that speeds the breakdown of proteins into amino acids.
protein: a large organic molecule composed of more than 40 amino acids chains organized ("folded") into complex structures; required for the structure, function, and regulation of cells, tissues, and organs; molecules of fewer than 40 amino acids are called peptides.
protein A: A 42-kDa monomeric protein from Staphylococcus aureus bacteria, protein A lacks cysteine residues and binds to the Fc portion of immunoglobulins. It is used extensively in affinity chromatography; ELISAs; and immunoblotting, -precipitation, and -histochemistry.
proteomics: the study of protein function and structure by organism.
protocol: documentation that ties together all SOPs (standard operating procedures) to direct the work performed in a regulated facility: who approves what, who is allowed to sign off on materials and products, where certain files and documents are kept, and so on; also a detailed plan for a clinical trial, stating (among other things) the trialis rationale, purpose, scope, dosages, routes of administration, length of study, and eligibility criteria.
protozoa: single-celled organisms, many of which are parasitic (e.g., the malaria parasite).
pseudopregnancy: a state resembling pregnancy that can occur in mammals following an infertile copulation.
pyrogen: a lipopolysaccharide found in the cell wall of Gram-negative bacteria that induces inflammation and fever as an immune response in higher organisms.
pyruvic acid (pyruvate): a colorless acid formed from glucose and glycerol as an important intermediate in metabolism or fermentation (glycolysis).
Q
QA/QC: Quality Assurance/Quality Control activities (and related company departments) responsible for testing, documenting, and enforcing product quality according to good manufacturing practice (GMP) regulatory requirements.
quadrivalent vaccine: a vaccine that contains four antigens.
qualification: documention showing that equipment is correctly installed, does what it is intended to do, and continues to operate within specified parameters.
R
RAC: Recombinant DNA Advisory Committee (USA) A public advisory committee to the Director of the NIH on the scientific, safety, and ethical issues involved in gene transfer research.
randomized trial: a study in which participants are randomly assigned to one of two or more trial arms to minimize potential grouping or prevalence of certain characteristics.
range: "the interval between the high and low levels of analyte studied".
reassortant virus: in viruses with segmented genomes, hybrid virions containing segments from different iparenti viruses can be produced by cells infected with different strains of the virus (giving rise to new strains).
receptor: a molecule on the surface of a cell that can bind antigens, antibodies, or other cellular components responsible for many of the immune system functions.
receptor (in relation to hormones): A cellular protein that binds hormones or neurotransmitters to initiate a physiologic response. Some receptors are located in the plasma membrane, and others are found within the cytoplasm or nucleus.
recovery: "expressed as the amount/weight of the compound of interest analyzed as a percentage to the theoretical amount present in the medium".
regeneration: To return a column packing to its initial state after elution, mobile phase is passed through the column in a gradient or stepwise. The stationary phase is restored to its initial condition. Regeneration may also refer to removing impurities with a strong solvent.
residue: an amino acid in/from a protein (described as a component of the polypeptide chain).
resin: a generic term for chromatography media, often (but not exclusively) referring to polymer beads.
resolution: In chromatography, the quality of separation is measured in terms of the purity of the resulting components. The higher the resolution (the more clearly those fractions are separate and distinguishable from one another), the greater the purity.
restriction endonuclease: an enzyme able to cleave the phosphodiester bonds within a nucleic acid strand by binding to DNA at a specific site.
retention factor (retention rate): Calculated from an adjusted retention time, the retention factor (k) describes the period of time a solute resides in/on the stationary phase relative to the time it resides in the mobile phase. (see: retention time)
retention time: Describing the time between sample injection and the appearance of a given solute's eluted peak maximum, retention time is adjusted to account for a column's void volume.
risk, risk factor: along with the probability that an event will occur (risk) are those factors of behavior, lifestyle, environment, or heredity associated with increasing or decreasing that probability.
RNA: ribonucleic acid that synthesizes protein within a cell, transferring information from DNA to the protein-forming system of the cell; also involved in expression and repression of hereditary information; its four main types are heterogeneous nuclear RNA (hRNA), messenger RNA (mRNA), transfer RNA (tRNA) and ribosomal RNA (rRNA).
robustness: "ICH defines robustness as a measure of the method's capability to remain unaffected by small, but deliberate variations in method parameters. Robustness can be partly assured by good system suitability specifications. Thus, it is important to set tight, but realistic, system suitability specifications.".
S
Saccharomyces cerevisiae: a species of yeast widely used in the production of alcoholic beverages, food, and biologic therapeutics.
salt: general term used for ionic compounds composed of positively charged cations and negatively charged anions, resulting in a net neutral charge.
SBB: Service of Biosafety and Biotechnology (Belgium) With the Biosafety Council, composes a single scientific advisory system that advises federal and regional authorities about biosafety in GMO-related matters, including specific regulations.
scale-up: the steps involed in transferring a manufacturing process or section of a process from laboratory scale to the level of commercial production.
Schizosaccharomyces pombe: a yeast species used for recombinant protein expression fermentations.
selectivity (factor): separation factor or relative retention.
semipreparative: preparative LC using analytical (4–5 mm ID) or slightly larger (6–10 mm ID) columns and milligram- to gram-size samples; usually to purify samples for analysis.
separation factor: thermodynamic factor used to measure relative retention of two substances.
seroconversion: development of antibodies in the blood that were not there before vaccination.
serum: fluid portion of blood; retains antibodies present in whole blood.
signal transduction: biochemical event that conducts the "signal" of a hormone or growth factor from the exterior of a cell, through the membrane and into the cytoplasm; involves receptors, ligands, messengers, and other molecules.
silica: Silicon dioxide, SiO2, occurring naturally in amorphous form or as crystals or microcrystals. Silica gel is commonly used as a solid medium in chromatography.
Society of Japanese Pharmacopoeia: Web site (Japanese only).
sodium–potassium pump: cell membrane proteins that move potassium ions into a cell while moving sodium ions out.
solid-substrate fermentation: growth of microbes on a solid material rather than in a liquid medium.
solubility: the degree to which a substance can be dissolved in a defined solvent.
solute: a substance dissolved in another substance (the solvent) to create a solution.
sparging: spraying; a sparger on a fermentor sprays air into the broth.
speciesism: prejudice based on species, especially discrimination against animals.
Spodoptera frugiperda: an insect species (common name fall armyworm) used in baculovirus protein expression systems.
stem cell: an undifferentiated cell that can divide to form specialized cells; pluripotent stem cells can differentiate into many different cell types.
sterilizing immunity: an immune response that is completely effective at preventing infection.
stereoisomers: two different molecules made up of the exact same atoms, having exactly the same neighbors, and differing only in spatial orientation.
strain: a genetic variant within a species.
substrate (in cell culture): surface on which a cell or organism grows or is attached — such as the use of microcarriers in cell culture; most eukaryotic cell types require attachment to a substrate for survival; also called extracellular matrices; in the body they are composed mainly of proteins and provide chemical cues that affect or guide the behavior of cells.
substrate (in downstream processing): solid particles that may be coated or have a chemically bonded phase for HPLC; the solid support does not contribute to the chromatographic separation itself (also called a support).
sugar: a simple carbohydrate molecule; usually crystalline and water soluble; the sugar in DNA nucleotides is deoxyribose, and that found in RNA nucleotides is ribose.
supercritical fluids: Highly compressed gases that combine properties of gases and liquids, they can lead to reactions that are difficult or even impossible to achieve in conventional solvents.
superovulation: the production of an exceptional number of ova at one time, induced in the production of transgenic animals.
surrogate marker: an indirect measure of disease progression.
suspending fluid: the substance that carries a vaccine into the body.
suspension culture: cell or tissue culture in which cells are grown in agitated liquid media.
symbiotic: a biological relationship in which two or more dissimilar organisms mutually benefit by living in close association with each other.
T
telomerase: an enzyme that directs replication of telomeres at the end of DNA strands; a reverse transcriptase that carries its own RNA template; inactive in regular cells, but active in cancerous cells.
telomeres: A series of repeated DNA sequences at the 5´ end of a chromosome that ensure correct chromosome replication during cell division; each time a cell divides, some of the telomeres are lost in the process, eventually leaving little or no telomeres and resulting in cell death.
thermodynamics: theory of heat and energy distribution, especially the conversion of energy from one form to another; commonly expressed as three laws.
thermokinetics: describes the specific movement of heat and energy in a given system.
thimerosal (also thiomersal): a mercury-based preservative used in some vaccines to prevent contamination and also used as a formulation ingredient in inactivated vaccines.
Ti-plasmids: tumor-inducing plasmids associated with agrobacteria.
tissue: a group of eukaryotic cells organized to perform a similar function.
titer: the quantity of one substance required to produce a reaction with a specific volume of another; also the number/measure of antibodies detected in blood.
toxicity: potential of a substance to exert a harmful effect on humans or animals, often used to refer to side effects of drugs.
toxin: any of various unstable poisonous compounds produced by some microorganisms and causing certain disease states.
TPD: Therapeutic Products Directorate (Canada) Responsible for the regulation — including evaluation and monitoring for safety, effectiveness, and quality — of pharmaceutical drugs, medical devices, and other therapeutic products available to Canadians.
transduction: transfer of genes from one bacterium to another using a phage (virus).
transfection: permanently changing a cell using viral DNA.
transformation: permanent genetic change following incorporation of new DNA.
transgene: foreign gene incorporated by transformation into the germline.
transplastomic: transformation of plastids.
trivalent vaccine: a vaccine that contains three antigens.
tRNA: transfer RNA, a small ribonucleic chain (74-93 nucleotides) that transfers amino acids to the ribosome to be placed in the order prescribed by the messenger RNA; tRNA molecules match up with a template strand of mRNA to facilitate formation of a specific sequence of amino acids into linear strands that are later processed in the cell to form proteins.
TSCA: Toxic Substances Control Act (USA) Authorizes EPA to, among other things, review new chemicals before they are introduced into commerce, including the examination of intergeneric microorganisms (microorganisms created to contain genetic material from organisms in more than one taxonomic genera).
turbidistat: continuous-mode fermentor in which fresh medium is introduced to keep turbidity constant.
U
UK: United Kingdom.
UN: United Nations.
UNCTAD: United Nations Conference on Trade and Development Intergovernmental organization intended to maximize the trade, investment, and development opportunities for developing countries and to assist their efforts toward integrating equitably into the world economy. Member of IANB.
UNIDO: United Nations Industrial Development Organization Sponsors BINAS and BIO-BIN.
urea: an organic compound of carbon, nitrogen, oxygen, and hydrogen; produced in the liver under the control of N-acetylglutamate.
USDA: United States Department of Agriculture (USA) Regulates all agricultural aspects of biotechnology in the United States including conducting its own research and tracking international regulations of genetically modified organisms.
USP: United States Pharmacopeial Convention Establishes and disseminates officially recognized standards of quality and authoritative information for use in manufacturing and testing drugs, excipients, and raw materials. Web site.
V
vaccine association: administering several vaccines to different sites of the body at the same time.
valence: measure of the number of antigens contained in a vaccine.
validation: documented proof that a procedure reproducibly gives results of acceptable accuracy, precision, sensitivity, etc.
VBU: Vereinigung deutscher Biotechnologie — Unternehmen Association of German biotechnology companies.
vector: a plasmid, virus, or other vehicle for carrying a DNA sequence into the cells of another species; also a method (such as genetically engineered viruses or bacteria) of delivering genetic material to cells.
virus: a microorganism that grows and reproduces in living cells of a host (bacteria, plant, or animal); the simplest form of life, more than 200 viruses are known to produce human disease.
virus-like particles (VLPs): noninfectious analogs of pathogenic viruses; cultured cells can be infected with a live virus, causing them to express viral proteins on their surfaces; once transferred into an individual, those viral proteins elicit an immune response, resulting in soluble antibodies in serum that in turn bind to live virus and block infection; VLPs also can be created by removing genes encoding for virulance from live viruses.
void: a space or gap, usually at the head of the column, caused by settling or dissolution of the column packing; sometimes filled with glass beads or packing resin.
volatile: describes an unstable substance that vaporizes or evaporates quickly.
W
water for injection (WFI): very pure water used for medical purposes.
whey acidic proteins: noncasein milk proteins containing eight characteristically spaced cysteine residues.
WHO: World Health Organization The United Nations specialized agency for health, governed by 191 member states through the World Health Assembly, which resolves major policy questions in addition to administering WHO.
working cell bank: cells used in pharmaceutical production grown from those maintained in a master cell bank so that their stability and uniformity are well characterized.
WTO: World Trade Organization International organization that deals with the rules of trade between nations to help producers of goods and services, exporters, and importers conduct their business. Member of IANB.
X
There are currently no words under the letter X
Y
yeast: single-celled ascomycete fungus that reproduces by budding or fission; produces enzymes that convert sugar to alcohol in a process called fermentation.
yeast: single-celled ascomycete fungus that reproduces by budding or fission; produces enzymes that convert sugar to alcohol in a process called fermentation.
yeast artificial chromosome (YAC): A vector constructed from the telomeric, centromeric, and replication origin sequences needed for replication in yeast cells used to clone pieces of DNA c.
Z
zest: zestfully clean.
