mole The amount of a substance that contains the same number of elements (such as atoms, molecules, or ions) as there are atoms
of carbon in 12 grams of carbon-12; one mole contains Avogadro's number of molecules (6.02 x 1023 ).
monomer A simple molecule that may combine with others to form polymers.
Messenger RNA; which serves as a template for protein synthesis. It is made as a complement to a DNA sequence and then transported from the
cell nucleus to the ribosomes.
Material safety data sheets; documentation (including data describing physical characteristics, toxicity, health effects, first aid, reactivity, storage,
disposal, protective equipment, and spill/leak procedures) that provides workers and emergency personnel with the proper procedures
for handling or working with a particular substance.
multicellular Referring to organisms composed of more than one cell — often billions of them — arranged in various organs, tissues, and
multimer Any small polymer; in BioPharm, usually a protein made up of more than one polypeptide chain
multimer formation Association of peptide or protein molecules to produce dimers (two linked identical molecules), trimers (three linked identical
molecules), and so on depending on how many identical molecules link up together
mutagen An agent (chemicals, radiation) that reacts with DNA to produce mutations.
mutagenicity The degree to which a substance can cause a change in an organism's DNA.
mutation A permanent change in DNA sequence or chromosomal structure.
molecular weight; refers to the mass of a molecule, usually stated in Daltons.
mycoplasma Parasitic microorganisms that infect mammalian cells, possessing some characteristics of both bacteria and viruses. Prokaryotic
microorganisms, family Mycoplasmataceae, with no cell walls (therefore resistant to many antibiotics) and needing sterols for maintenance and growth. Potential contaminants
of mammalian cell cultures, they may grow attached or close to cell surfaces in the cytoplasm, subtly altering properties
of the cells, but escaping detection unless specifically monitored. In cell culture of biopharmaceuticals, each lot must be
tested at the end of cell culture for mycoplasma contamination; a confirmed positive results in batch rejection.
myeloma Lymphocytic cancer; a malignancy found in bone marrow.
native The natural state; in BioPharm context, it usually refers to a molecule's normal three-dimensional structure under optimal conditions.
NDA The New Drug Application; CDER's equivalent of the BLA. It is used for small-molecules and some biopharmaceuticals (such as hormones and small peptides),
which are regulated by CDER rather than CBER.
nebulizer A device, pressurized by an oxygen or nitrogen tank, for the purpose of converting a liquid (such as a medicinal formulation)
into a fine mist (to be inhaled, for example).
nick translation A technique used to introduce radioactively and nonradioactively labeled nucleotides into DNA; the new nucleotide is added
at the position where the original nucleotide was excised; nick translation can be used for a number of hybridization techniques,
such as gel blots and colony plaque lifts.
National Institutes of Health, the US government agency that conducts and supports medical research and dissemination of information. One of eight agencies
in Public Health Services, which is in turn part of the US Department of Health and Human Services.
Near-infrared spectroscopy; a bioanalytical technique that uses radiation in the near-infrared range to provide rapid, nondestructive analysis of materials.