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 (electroblotting). 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.
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.
cake The solid sediment that has been compacted in a centrifuge after removal of as much liquid as possible; or the remaining solid
after completion of a lyophilization.
calorimetry Analytical method that measures heat loss or gain resulting from physical or chemical changes in a sample. Differential scanning
calorimetry compares the results of heating a sample to those for heating a reference material—for example, to measure the
temperature at which the sample crystallizes, changes phase, or decomposes.
campaigned production Continuous production of successive batches of the same product.
CAPA Corrective and preventive action; a quality system defined by 21CFR820.100; the policies, procedures, and support systems
that enable a firm to assure that exceptions are followed up with appropriate actions to correct the situation, and with continuous
improvement tasks to prevent recurrence and eliminate the cause of potential nonconforming product and other quality problems.
CCDs are used in cameras that take photomicrographs.
capillary electrophoresis The miniaturized instrumental version of traditional electrophoresis using capillary column technology (that is, tiny fused-silica
tubes with 20–100 µm inner diameters) and light-absorbance or fluorescence detection.
capsid The outer protein shell of a virus particle (virion).
carbonyl bond An oxygen atom double-bonded to a carbon atom; the carbon atom then has two additional bonds to attach to the rest of the
carcinogenic Cancer-causing; many agents that are carcinogenic are mutagens (agents that increase the occurrence of mutation).