laminar flow clean air device A clean bench, clean workstation, and wall or ceiling modules or other devices that incorporate a HEPA/ULPA filter and motor
blower for supplying clean air in one direction for a controlled work space; more correctly referred to as "unidirectional
airflow," which is air flow having generally parallel streamlines operating in a single direction and with uniform velocity
over its cross section.
ligands Molecules that bind to other molecules. In a binding action, usually the smaller of the two molecules is considered the
Luer-lock A pressure-locked connection between a needle and syringe body.
lyophilization Freeze-drying; a procedure by which a liquid solution is frozen and then placed under lowering pressure to remove ice crystals
(primary drying), then heated to remove the unfrozen water by sublimation.
mass spectrometry Analytical method that measures the difference in mass-to-charge ratio (m/e) of ionized atoms or molecules to separate them
from each other. Mass spectrometry is useful for counting atoms or molecules and also for determining chemical and structural
information about molecules (molecules have distinctive fragmentation patterns). In the study of proteins, mass spectrometry
data are often combined with liquid chromatography results.
melting temperature (Tm) The melting temperature refers to the midpoint in the transition from one state to another; for example, from folded to
unfolded, or, in the case or a powder, from rigid to viscous.
metered dose inhaler (MDI) A metal canister containing a drug formulation and propellants and placed in a plastic holder that precisely measures out
a formulation dose for inhalation.
microheterogeneity Heterogeneity that is localized to a relatively small region, as in an amino acid sequence or the structure of a polypeptide
microspheres Tiny polymer spheres (usually biodegradable) measured in micrometers.
multimer formation Association of peptide or protein molecules to produce dimers (two linked molecules), trimers (three linked molecules),
and so on depending on how many identical molecules link together.
multiphase solidification Material, such as the plastic used in blow-fill-seal, is heated to suitable viscosity, squeezed through a nozzle by a pumping
system, and deposited layer by layer; the molten material solidifies when it contacts the previous layer; the contact of the
liquefied material leads to partial remelting of the previous layer for good bonding of the layers.
native The natural state; in biopharmaceutical development, it usually refers to a molecule's normal three-dimensional structure
under optimal conditions.
nebulizer A device, pressurized by an oxygen or nitrogen tank, for the purpose of converting a liquid medication into a fine mist
oxidation Combination with oxygen or subjection to its action.
parenteral delivery Drug delivery by injection; subcutaneous, intramuscular, and intravenous delivery are most common.
parison a hot quantity of soft or molten polymer (or glass) that is partly blown or formed into a shape before its final shaping
in a mold.
PEGylation Attachment of a polyethylene glycol molecule to a protein molecule.
peptide bond A covalent bond (link) between an amino group of one amino acid and a carboxyl group of another. This linkage does not allow
free rotation, and it is the important bond that holds amino acid monomers together to form the polymer known as a polypeptide.
peptide mapping Obtaining a characteristic pattern of peptides by partial hydrolysis (cleavage, digestion) of a protein and separation by
chromatographic means to produce a "fingerprint" of it.
pH Measurement of the relative alkalinity or acidity of a solution based on a chemical logarithm. Pure water is pH neutral
(7), acidic solutions have pH values between 0 and 7, and alkaline or basic solutions have pH values between 7 and 14.
pharmacokinetics Study of a drug and its metabolites in the body after administration by any route.