Glossary

Biologic
A therapeutic or prophylactic derived from a living source (human, animal or unicellular). Most biologics are complex mixtures that are not easily identified or characterized, and many are manufactured using biotechnology. Biological products often represent the cutting edge of biomedical research and are sometimes the most effective way to prevent or treat disease

Bioprocess
A process in which living cells, or components thereof, are used to produce a desired product

Biosimilar
A biologic that is similar to, but not the same as, an innovator biologic.  Also sometimes called a follow-on biologic.

Biotechnology
The use of biological processes to solve problems or make useful products

Cell
The smallest structural unit of a living organism that can grow and reproduce independently

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.

Embryonic Stem Cells
Cells that can give rise to any type of differentiated cell. They can be derived from two sources: the inner cell mass from a blastocyst or the primordial germ cells (eggs and sperm) of an older embryo

Enzyme
A protein catalyst that facilitates specific chemical or metabolic reactions necessary for cell growth and reproduction

FDA
The Food and Drug Administration is an agency within the U.S. Public Health Service, which is a part of the Department of Health and Human Services.  The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.  The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Immunogen
Any substance that can elicit an immune response

Immunogenicity
The property enabling a substance to elicit an immune response, or the degree to which a substance possesses this property.

Innovator
An original product and its associated manufacturer.  The innovator is usually the first to receive regulatory approval conducts the original, extensive research and development on a product.

Interchangeable
A product is interchangeable if the FDA determines is can be safely substituted for the innovator product.

Oncogene
Gene thought to be capable of producing cancer

Peptide
Two or more amino acids joined by a linkage called a peptide bond

Pharmacogenomics
The science that examines the inherited variations in genes that dictate drug response and explores the ways these variations can be used to predict whether a patient will have a good response to a drug, a bad response to a drug, or no response at all.

Polypeptide
Long chain of amino acids joined by a peptide bond

Therapeutics
Compounds that are used to treat specific diseases or medical conditions