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Biotech Industry Overview - Industry Terms

LMSB-04-0207-019 

"This document is not an official pronouncement of the law or the position of the Service and cannot be used, or cited, or relied upon as such."

4.  Industry Terms

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.

Chapter 3 | Table of Contents | Chapters 5, 6, & 7

Page Last Reviewed or Updated: 03-Mar-2014