bioreactor A vessel capable of supporting a cell culture in which a biological transformation takes place (also called a fermenter 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.
Biologies 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.
blotting Transfer of nucleic acids or proteins from an electrophoresis gel strip to a chemically reactive paper or membrane (such as
nitrocellulose paper) or matrix (nylon, for example)—to which they bind. Blotting is achieved through capillary diffusion
(when the gel is placed between the paper or matrix and an absorptive pad) or through electrophoresis (electroblot-ting).
Of the three types of blots, Southern hybridization (or Southern blot) transfers DNA; Northern blots transfer RNA, and Western
blots transfer proteins (also called protein blots).
bolus A concentrated mass of injected medication.
bond A mechanism through which atoms, ions, or groups of atoms are held together in a molecule.
Blotting methods make electrophoresis results permanent.
broth The contents of a microbial bioreactor: cells, nutrients, waste, and so on.
Bovine serum albumin; a protein derived from cow serum and commonly used as a growth additive for animal cell culture.
Bovine spongiform encephalopathy; the TSE of cattle believed capable of crossing the species barrier to have become feline spongiform encephalopathy (FSE) in
cats, transmissible mink encephalopathy (TME) in farmed mink, and vCJD in human beings.
buccal delivery Transmucosal (across the mucosal membranes) drug delivery by way of the mouth.
buffer (buffering agent) A solution containing a weak acid and a conjugate base of this acid; it resists change in pH near a specific value when an
acid or a base is added to it because the acid neutralizes any added base and vice versa. For example, bicarbonates and some
proteins in biological fluids, when in solution, tend to stabilize the hydrogen-ion concentration by neutralizing (within
limits) both acids and bases so the solution resists changes in pH.
bulk active ingredient Also bulk drug substance, the active ingredient that is formulated with excipients to produce the drug product formulation.
Biopharmaceuticals are produced "in bulk" through bioprocessing.
bulking agent An additive that increases the volume of a solution or a solid.