toxicology Study of harmful substances: what they are composed of and which part is harmful, how they exert their effect, whether an
antidote exists, and how the antidote works.
trade secret any unpatented and/or unpatentable trade-secret information and proprietary technology of any kind or nature owned by a
company, such as a process method, formulation, or other information that adds value to a product or process.
transcription Synthesis involving RNA polymerase of complementary RNA from a sequence of DNA.
transdermal delivery Drug delivery across the skin, accomplished without breaking the skin. For large molecules like proteins and peptides, this
is possible only through iontophoresis.
transgenics The alteration of plant or animal DNA so that it contains a gene from another organism. There are two types of cells in animals
and plants, germ line cells (the sperm and egg in animals, pollen and ovule in plants) and somatic cells (all of the other
cells). Germ-line DNA is altered in transgenic animals and plants so those alterations are passed on to offspring. That is
done to produce therapeutics, to study disease, and to improve livestock strains. Transgenic plants have been created for
increased resistance to disease and insects as well as to make biopharmaceuticals.
translation The process by which information transferred from DNA by RNA specifies the sequence of amino acids in a polypeptide (protein)
transmucosal delivery Drug delivery across mucosal membranes, such as the nasal lining, the inside of the mouth, or the rectal wall.
treatment IND An IND that makes a promising new drug available to desperately ill patients as early in the drug development process as possible.
FDA permits the drug to be used if there is preliminary evidence of efficacy and it treats a serious or life-threatening disease,
or if there is no comparable therapy available.
trehalose A sugar (nonreducing disaccharide) found in certain algae and plants, some bacteria, and some insects. It is used as a preservative
and stabilizer in some biopharmaceutical formulations.
trend A statistical term referring to the direction or rate of change of a variable(s) [from ICH Q9].
trifluoroacetic acid A nonflammable, hygroscopic (takes up moisture), colorless liquid used as a reagent, solvent, catalyst, and strong nonoxidizing
Transfer RNA, a type of RNA with triplet nucleotide sequences that complement the nucleotide coding sequences of mRNA. In protein synthesis,
tRNA bonds with amino acids and transfers them to the ribosomes, where proteins are assembled according to the genetic code
carried by mRNA.
Tryptophan, one of over 20 naturally occurring amino acids.
trypsin An enzyme capable of cleaving peptide bonds. It is used to remove adherent cells from a surface and to break up (digest) purified
proteins for analysis.
tryptic fragment analysis Identifying and quantitating the peptides resulting from tryptic digestion.
Transmissible spongiform encephalopathies, neurological disease in mammals of many species, generally believed to be caused by prions.
turbidostat A variation on a chemostat. Whereas a chemostat is designed for constant input of medium, a turbidostat is designed to keep
the organisms at a constant concentration. A turbidity sensor measures the concentration of organisms in the culture and adds
additional medium when a preset value is exceeded.
turbulent flow field The state that results from mixing the contents of a fermentor or bioreactor to provide oxygen to the cells. That must be
balanced against the shear that causes cell damage and death.
turnkey system A piece of equipment, process train, or manufacturing plant that is delivered to the customer in a ready-to-run condition,
specialized for the customer's application, with no additional equipment or modifications required.
Tyrosine, one of over 20 naturally occurring amino acids.
ultrafiltration Filtration under pressure.