bioanalytical Analytical methods that pertain to biotechnology (that is, to proteins, peptides, and other biomolecules) are more specifically
referred to as bioanalytical methods.
bioassay Inoculation of an infective substance into an animal to see if it develops the same disease as a control animal; other analytical
methods that use living cells, tissues, or organisms as test subjects.
bioavailability Measure of the true rate and the total amount of drug that reaches the target tissue after administration; extent to which
the active drug ingredient enters systemic circulation, thereby gaining access to the site of its action.
bioburden The number of contaminating microbes (bacteria, yeast, mold, etc.) on or in a certain amount of material before that material
has been sterilized.
bioburden assay Microbiological test that enumerates microbial content of a sample, but that is not validated to determine sterility.
biocalorimetry Bioanalytical calorimetry.
bioequivalency A scientific basis on which generic and brand-name drugs are compared with one another. Drugs are bioequivalent if they enter
circulation at the same rate when given in similar doses under similar conditions.
biogeneric A biopharmaceutical that is produced and licensed by a different firm than the one that originally licensed the molecule.
A biogeneric is used for the same indications and may be produced by a substantially similar process, or one that is different,
but results in comparable product.
bioinformatics Use of computers in the life sciences: for instance, searching and analysis of electronic databases of genomes and protein
sequences, and computer modeling of biomolecules and biologic systems.
biologics Products of living organisms used in the prevention or treatment of disease.
biomass The dry weight estimation of organisms (usually microorganisms) in a given habitat or medium.
biometabolism Physical and chemical processes that occur within a cell or an organism — the conversion of nutrients into energy, for example.
biopharmaceutical A therapeutic product created through the genetic manipulation of living things, including (but not limited to) proteins and
monoclonal antibodies, peptides, and other molecules that are not chemically synthesized, along with gene therapies, cell
therapies, and engineered tissues.
bioprocessing Using organisms or biologically derived macromolecules to carry out enzymatic reactions or to manufacture products.
bioreactor A vessel capable of supporting a cell culture in which a biological transformation takes place (also called a fermentor or
biosimilar A biopharmaceutical that is produced using a different cell line or master cell bank and/or different process, yet meets
criteria for comparability in clinical activity. A biosimilar may differ in its purity/impurity profile, and its potency may
differ in a definable way. (See also biogeneric, follow-on biological)
biotechnology The industrial use of living things, specifically genetically engineered organisms.
Biologics license application; the required application for marketing a biologic product in the United States. Most biotechnology-derived drugs are approved
through a BLA, rather than an NDA, although some biologics, such as recombinant insulin and human growth hormone, considered
to be simpler in structure and well-characterized, have been approved under NDAs.
blinding Clinical trial technique in which, to eliminate bias in a research study, subjects (and sometimes clinical investigators)
remain unaware of which therapeutic approach (for example, investigational product or standard treatment) is provided.
blood–brain barrier To protect the brain from infection and from damage that could be caused by foreign chemicals, the endothelial cell linings
of its capillaries are tightly packed together. Nothing but water and nutrients that are actively transported by cellular
mechanisms can pass through.