tangential flow filtration A separation method that transfers components of one system (stream) into another. The stream the product is being extracted
from crosses the stream that the product is being transferred to multiple times.
target Organ, tissue, or molecule involved in a disease that is modified or affected by a potential therapeutic.
targeted delivery Drug delivery that is specifically directed to the therapeutic molecule's site of action by one of various means such as a
targeting monoclonal antibody (that binds specifically to a particular kind of receptor) or surgery (in which a drug formulation
is injected into a particular location, such as the liver).
Tcell A synonym for T lymphocyte, T cells are a type of leukocyte (white cells of the blood and lymphoid system) that (along with
the less numerous B lymphocytes in the bloodstream) are necessary for conferring antibody-independent cellular immunity. Of
their subsets, cytotoxic or killer T cells can kill cells bearing specific antigens, helper T cells can help B cells form
antibodies, and suppressor T cells suppress the activity of other cells involved in immune responses.
Team Biologies A partnership between FDA's Office of Regulatory Affairs (ORA) and CBER to focus on inspection and compliance issues in biologics.
Its goal is to ensure the quality and safety of biologic products and resolve inconsistencies.
tertiary structure The three-dimensional folding (its normal state) of a polypeptide chain in a protein molecule.
threonine; one of more than 20 naturally occurring amino acids.
thrixotropy The property of some non-Newtonian pseudoplastic fluids to show a time-dependent change in viscosity.
throughput The movement of a material through a system; specifically, a measure of the quantity of a substance passing through a piece
of equipment or section of a pipe or pump line during a specified time.
time-of-flight (TOF) mass spectrometer A mass analyzer that separates ions of different mass-to-charge ratios by their time of travel through a field-free vacuum
region after having been give the same kinetic energy. The velocity of the ions is dependent on the mass-to-charge ratio and,
as the ions are traveling over a fixed distance, the time taken to reach the detector allows the mass-to-charge ratios to
be determined with heavier ions taking longer.
tissue culture Growing plant or animal tissues outside of the body, as in a nutrient medium in a laboratory; similar to cell culture, but
cells are maintained in their structured, tissue form.
liter A measured sample. (To draw a measured, representative sample from a larger amount is to titrate.)
TOC analysis Total organic carbon analysis; an analytical method whereby organic carbon is oxidized to produce CO2, the amount of which produced is directly proportional to the amount of carbon present. Measurement of CO2, as a result, indicates the presence of organic molecules. The biopharmaceutical industry uses TOC analysis to test pure
water and to evaluate and validate cleaning procedures.
top-down sequencing The identification and characterization of intact protein from tandem mass spectrometry experiments, enabling the identification
of post-translation modifications. The top-down approach provides direct measurement of the intact mass of the protein, as
well as fragment ion information relating to the amino acid sequence.