BEVS Baculovirus expression vector system; an insect cell culture method in which a genetically engineered virus transfers recombinant DNA to the insect cells it infects, which then produce the peptide or protein in large quantities.

BFS Bbw-fill-seal; a type of fill-and-finish system used in the pharmaceutical industry that forms a plastic container, fills that container, and then seals it with in-line machinery.

BHK Baby hamster kidney cells; an established mammalian cell line that is commonly used for biotechnology.

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.

Biopharmaceutical development, manufacturing, and analytical methods use a variety of buffer solutions.

bioburden assay Microbiological test that enumerates microbial content of a sample, but that is not validated to determine sterility.

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.

biological activity The specific ability or capacity of a product to achieve a defined biological effect. Potency is the quantitative measure of biological activity. [From ICH Q6B]

biologies Products of living organisms used in the prevention or treatment of disease.

biomarker The presence or absence of an enzyme, receptor, other protein or peptide, a mutated mRNA, or a genetic mutation, that differentiates patient sub-populations and is indicative of a disease, the disease severity, a stage in a disease, a subpopulation with the disease that are differentiated by their drug response, or a subpopulation of people with a different drug activity or pharmacokinetics.

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.

BiopharmaLynx™ Application Manager for MassLynx™ Software; Software available from Waters Corporation that automates the process of data analysis and reporting of mass spectrometry data for peptide maps and intact mass measurements. It automatically analyzes and assigns results, defining the sequence/features of known proteins, and determining the ID of modified forms. Allows users to edit assignments, annotate new peaks, and compare experimental samples to a reference by using tabular and graphical visualization tools.

bioprocessing Using organisms or biologically derived macromolecules to carry out enzymatic reactions or to manufacture products.