Biotech Industry Overview - Industry Terms
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Agonist: A drug that promotes certain kinds of cellular activity by binding to a cells receptor.
Amino Acids: Building blocks of proteins.
Antagonist: A drug that prevents certain types of cellular reactions by blocking other substances from binding to a cells receptor.
Antibody: A protein produced by certain types of white blood cells to deactivate foreign proteins.
Antigen: Any substance that induces a body's immune response.
Antisense: A drug that is the complimentary image of a small segment of messenger RNA (mRNA), the substance that carries instructions from cells genes to its protein-making machinery.
Assay: A test that measures a biological response.
Autoimmune disease: A condition such as multiple sclerosis where the body produces antibodies against its own tissues.
Bioavailability: The percentage of a drugs active ingredient that reaches patients bloodstream and body tissues.
Bioinformatics: A system whereby biological information is collected, stored, and accessed via computers and similar other electronic media.
Biologicals: Also known as biological drugs, they are medicinal preparations made from living organisms or their byproducts. Vaccines, antigens, serums, and plasmas are examples of biologicals.
Biologics license application (BLA): The formal filings that drug makers submit to the FDA for approval to market new biologic-based drugs. The application must contain clinical evidence of the compounds safety and efficacy.
Bioremediation: The use of microorganisms to remedy environmental problems, rendering hazardous waste nonhazardous.
Biosynthesis: Production of a chemical by a living organism.
Biotransformation: The use of enzymes in chemical synthesis to produce chemical compounds of a desired stereochemistry.
Breakthrough Drug: A compound whose mode of action is significantly different from that of existing drugs, representing a major therapeutic advance.
Chemotherapy drugs: Drugs used to treat cancers.
Chromosomes: Microscopic, threadlike components in the nucleus of a cell that carry hereditary information in the form of genes.
Clinical Trials: Test in which experimental drugs are administered to humans to determine their safety and efficacy.
Clone: A term that is applied to genes, cells, or entire organisms that are derived from and are genetically identical to a single common ancestor gene, cell or organism respectively.
Clotting factors: Proteins involved in the normal clotting of blood.
Colony-stimulating factors: Proteins responsible for the controlling production of white blood cells.
Combination therapy: The use of two or more drugs that together has greater therapeutic power in treating illnesses and diseases than either used alone.
Deoxyribonucleic acid (DNA): The basic molecule that contains genetic information for most living systems.
DNA chip: A micro array used to analyze DNA sequences, ascertain gene expression or detect single nucleotide polymorphisms (SNPs).
Drug Delivery: The process by which a formulated drug is administered to the patient. Traditional routes have been oral or intravenous perfusion. New methods deliver through the skin with a transdermal patch or across the nasal membrane with an aerosol spray.
Enzyme: Protein that controls chemical reactions in the body.
Fermentation: The process of growing microorganisms for the production of various chemical or pharmaceutical compounds.
Fusion: Joining the membrane of two cells, thus creating a daughter cell that contains some of the same properties from each parent cells.
Gene: The basic determinant of heredity, genes are chromosomal segments that direct the syntheses of proteins and conduct other molecular regulatory functions.
Gene sequencing: Decoding DNA strands into the specific order of its four nucleotides.
Gene therapy: The introduction of genes into a patient's body to replace the defective ones or to suppress the action of a harmful one.
Genetic screening: The use of specific biological tests to screen for inherited diseases or medical conditions.
Genetic testing: The analysis of an individual’s genetic material. Can be used to gather information on an individual’s genetic predisposition to a particular health condition or to confirm a diagnosis of genetic disease.
Genome: The total complement of genetic material in a cell, comprising the entire chromosomal set found in each nucleus of a given species.
Genomics: The study of genes and their function, including mapping genes within the genome, identifying their nucleic acid structures, and investigating their functions.
Growth Factors: Proteins responsible for regulating cell proliferation, function, and differentiation.
Human growth hormone: Pituitary hormone that stimulates the growth of long bones in prepubertal children.
Immunomodulator: A drug that attempts to modify the immune system.
Interferon: A glycoprotein, produced naturally by cells, which interferes with a virus's ability to reproduce after it invades the body.
Interleukin: An endogenous substance that stimulates the production of different types of white blood cells or leukocytes.
Investigational new drug (IND): Regulatory classification of an experimental new compound that has successfully completed animal studies and has been approved by the FDA to proceed to human trials.
In vitro: Literally "in glass" performed in a test tube or lab apparatus.
In vivo: In the living organism.
Macrophage: A type of white blood cell that is involved in the production of interleukin 1. These substances are being studied as potential anticancer therapies.
Monoclonal Antibodies: Large protein molecules produced by white blood cells, which seek out and destroy harmful foreign substances.
New drug application (NDA): The formal filing that drug makers submit to the FDA for approval to market new chemical based drugs.
Orphan drug: A drug designed to treat rare diseases afflicting relatively small patient populations (currently less than 200,000 cases).
Polymerase: General term for enzymes that carry out the synthesis of nucleic acids.
Preclinical studies: Studies that test a drug on animals and in other non human test systems.
Priority review: An investigational drug that receives this status from the FDA will be reviewed within 6 months of its BLA or NDA submission.
Prodrug: An inactive compound that converts to an active agent through contact with a specific enzyme.
Proteome: The set of all proteins expressed by a genome.
Proteomics: The study of encoded proteins and their function, with emphasis on the role proteins play in the disease process.
Recombinant DNA technology: The process of creating new DNA by combining components of DNA from different organisms. Usually the new DNA is then incorporated into therapeutic substances.
Regeneration: Laboratory technique for forming new plant from a clump of plant cells.
Scale Up: Transition from small-scale production to large industrial quantities.
Single nucleotide polymorphism (SNP): A variation in the sequence of a gene due to a change in a single nucleotide.
Tissue plasminogen activator (TPA): A substance produced in small amounts by the inner lining of blood vessels, it prevents abnormal blood clotting.
Treatment IND: An FDA program that allows experimental drugs treating life threatening illnesses to be made available to very sick patients before the drugs obtain FDA approval.
Tumor necrosis factors (TNF): Rare proteins of the immune system that appear to destroy some types of tumor cells without affecting healthy cells.
Vaccine: A preparation that contains an antigen consisting of whole disease-causing organisms (killed or weakened) or parts of such organisms, used to confer immunity against the disease that the organisms cause.
Vector: The agent (plasmid or virus) used to carry new DNA into a cell.
Virus: A submicroscopic organism that contains genetic information but cannot reproduce itself.
Xenotransplantation: The process of transplanting organs, cells or tissues from animals into humans.