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.
Taxonomy
The development of approaches to organize and summarize our knowledge about
the variety or organisms that exist.
Tay-Sachs Disease
An inherited disease of infancy characterized by profound mental
retardation and early death; it is caused by a recessive gene mutation.
Team Biologics
A partnership between FDA's Office of Regulatory Affairs (ORA) and CBER to
focus on inspectional and compliance issues in biologics. Its goal is to
ensure the quality and safety of biologic products and resolve
inconsistencies.
T-Cell (T-lymphocyte)
A blood cell, probably originating from bone marrow, but which matures in
the thymus. Some T-cells are responsible for cell-mediated immunity and in
the production of antibodies.
- Telomere The end of a chromosome. This specialized structure is
involved in the replication and stability of linear DNA molecules.
- Temperature
A specific degree of heat intensity. There are three temperature
designations associated with psychrometrics: 1. Dry Bulb (DB) - The air
temperature as measured by a standard thermometer. 2. Wet Bulb (WB) - The
air temperature measured by a thermometer with its reservoir bulb wrapped
in a moistened cloth wick and exposed to an air stream moving at a
velocity of 1,000 feet per minute. 3. Dewpoint temperature (DP) - Also
called Saturation Temperature is the temperature at which condensation of
moisture begins (air is holding 100% of the moisture it can) when the air
is cooled, measured in °F.
Terminal Sterilization
The process applied to product sealed in its final container that
transforms a non-sterile product into a sterile one.
Terminal Sterilization
This term is a gross misnomer because it refers specifically to the
terminal heat sterilization of LVPs usually by steam.
Terminally Ill
For an individual, it means that the subject has a life expectancy of six
months or less as stated in writing by his or her attending physician and
surgeon.
Test Procedure
A sequence of activities which when executed successfully provides
documentary evidence that part of the system works as specified.
Theoretical Yield
The quantity that would be produced at any appropriate phase of
manufacture, processing, or packing of a particular drug product, based
upon the quantity of components to be used, in the absence of any loss or
error in actual production.
Thermophile
An organism that grows best at greater than 50ºC (122ºF).
Thermophilic (Of A Microorganism)
With optimum temperature for growth above 45ºC, many thermophilic
bacteria exist at high temperatures (greater than 80ºC) and many of
their enzymes which posses high thermal stability, are of great commercial
interest.
Thrombin (Blood Coagulation Factor II)
An enzyme (the activated thrombogen) formed in the blood, after this is
shed, that converts fibrinogen into fibrin for clot formation. It is
formed from conjunction of prothrombin and calcium salts. It is also a
sterile protein substance prepared from prothrombin of bovine origin
through interaction with thromboplastin in the presence of calcium. Bovine
thrombin is often used to aid production of serum from "salvage"
plasma.
Thrombosis
Clotting within a blood vessel that may cause infarction of tissues
supplied by the vessel.
Throughput Volume
The amount of solution passed through an exchange bed before the resin is
exhausted.
- A pyrimidine component of nucleic acid first isolated from the
thymus.
- TIG (Tungsten Inert Gas)
Time Stamp
A part of the audit trail that clearly documents the sequence of events
in human terms, helping to authenticate an electronic signature and
minimizing the chances of signer repudiation. A local time stamp
correlates with the whereabouts of the signer. With client-server data
systems used by international companies and records accessed from remote
sites (such as on business trips), time stamps that reflect the local time
of only the user might make the sequence of actions for an individual
record appear inconsistent. For example, the approval by a peer reviewer
could be signed at 9:00 a.m. on a chromatographic analysis that was
performed at 11:00 a.m. in a different time zone. Local time stamps should
probably be supplemented consistently with the time stamp of a remote
server, with one stamp clearly labeled as local.
Tincture of Iodine
A germicidal solution of iodine in aqueous alcohol used primarily as
antiseptic on skin and tissue.
Tissue Culture
Growing mammalian cells in the laboratory in a tissue culture medium (in
vitro). For example, this allows researchers to determine the effects of
various chemicals on mammalian cells without experimenting directly on
live animals or man. Since a molecule of some toxic substances can harm a
single mammalian cell, even one part-per-billion of some impurities can
affect a tissue culture. Therefore, water used to make up tissue culture
media should be extremely pure.
Titer
A measured sample - the strength of a solution or the concentration of a
substance (as an antibody) in solution as determined by titration.
Titration
Volumetric analysis by means of the addition of definite amounts of a
test solution to a solution of a known amount of the substance analyzed.
TNT (Tumor Necrosis Therapy)
Therapeutic agents that target dead and dying cells found primarily at
the core of the tumor.
Toe of Weld
The junction between the face of a weld and the base material.
Tolerance
Failure to mount an immune reaction on exposure to what would normally be
an antigenic substance.
Ton of Refrigeration
A unit used to indicate the size of a refrigeration unit. One ton of
refrigeration effect is equivalent to removing 12,000 Btu/hr of heat, or
melting one ton of ice in a 24-hour period.
Topical
A medication applied to the skin, an ointment. Usually a medicament
suspended in a carrier such as petrolatum or another oil based carrier.
Filtration at elevated temperatures is usually possible.
Topical Product
A pharmaceutical product meant to be applied to the skin or soft tissue
in the form of liquid, cream, or ointment, and therefore needs not be
aseptic. Sterile ophthalmic products throughout are manufactured
aseptically.
Total Bacteria Count
An estimation of the total number of bacteria in a sample based usually
on Standard Methods procedures for collecting, incubating, and counting
colony-forming units (cfu).
Total Dissolved Solids (TDS) The term used to describe inorganic ions
in the water. Usually measured by electrical conductance of the water
corrected to 25°C, and expressed as ppm (parts per million).
Total Heat (TH)
The sum of sensible heat and latent heat.
Total Ionized Solids
Concentration of dissolved ions in solution expressed in concentration
units of Sodium Chloride (NaCl). It determines the operating life of ion
exchange resins and is calculated from measurements of Specific
Resistance.
Total Organic Carbon (TOC)
A measure of the level of organic impurities in water by their carbon
content that determines the operating life of activated carbon beds. This
is one of the parameters used to determine the purity of Semiconductor
Grade water. Feed water will have TOC measured in ppm (parts per million),
and ultrapure water (UPW) will have TOC measured in ppb (parts per
billion).
Total Solids
Total solids in water include both dissolved and suspended solids.
Determined by weighing sample before and after evaporation.
Toxic
Pertaining to a substance that is harmful.
Toxicology
A science that deals with poisons, their effects, and the problems
involved.
Toxin
A substance produced by microorganisms that can inhibit cell growth in
tissue culture and may cause temperature rise in animals.
Toxin
Any poisonous agent, especially a poisonous substance produced by one
living organism that is poisonous to other organisms. Toxins are usually
very unstable, notably toxic when introduced into the tissues, and
typically capable of inducing antibody formation.
Toxoid
An antigenic toxin. Example is tetanus toxoid that is a bacterial
vaccine.
TPA (Tissue Plasminogen Activator)
A recombinant drug used in the management of heart attacks to prevent
clotting. Produced by Genentech and one of the first successful
recombinant DNA drugs to be commercialized.
Trace Analysis
Analyzing constituents present in ppm and ppb concentrations. Trace
analysis requires extremely pure reagents, made with ultrapure Type I
reagent grade water.
Traceability
A prerequisite for trustworthy records, apart from data security.
Traceability is the part of the laboratory data system audit trail that
holds the evidence of who did what to a record and when.
Tracer
A radioactively labeled nucleic acid component included in a
reassociation reaction in amounts too small to influence the progress of
reaction.
Transcription
The process by which the genetic information encoded in the gene,
represented as a linear sequence of deoxyribonucleotides (DNA), is copied
into an exactly complementary sequence of ribonucleotides known as mRNA
(messenger RNA).
Transduction
The transfer of genetic material from one cell to another by means of a
viral vector (for bacteria, the vector is Bacteriophage).
Transfection
The acquisition of new genetic markers by addition of viral DNA to cells.
Transfer Panel
A panel to which process and utilities are piped, allowing cross
connections between different use points. A jumper spool is used to
connect the desired process/utility users and mechanically preclude
erroneous connections to other lines.
Transfer RNA (tRNA)
A class of RNA having structures with triplet nucleotide sequences that
are complementary to the triplet nucleotide coding sequences of mRNA. The
role of tRNAs in protein synthesis is to bond with amino acids and
transfer them to the ribosomes, where proteins are assembled according to
the genetic code carried by mRNA.
Transfer Systems
Equipment allowing the introduction and removal of material, toxic and/or
sterile, with continuous protection to both operator and product.
Transformation
A process by which the genetic material carried by an individual cell is
altered by incorporation of exogenous DNA into its genome.
Transgenics
The alteration of a plant or animal's DNA such that it contains a gene
from another organism. There are two types of cells in animal and plants,
germ line cells (the sperm and egg in animals, pollen and ovule in plants)
and somatic cells (all other cells). Transgenic animals have alterations
in their germ line DNA so the alterations are passed on to the offspring.
That is done to produce therapeutics, to study disease, and to improve
farm animals. Transgenic plants have been created for increased resistance
to disease and insects as well as to make biopharmaceuticals.
Translation
The process in which the genetic code carried by mRNA directs the
synthesis of proteins from amino acids.
Treatment Investigational New Drug
An Investigational New Drug that makes a promising new drug available to
desperately ill patients as early in the drug development process as
available. 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 not comparable therapy available.
Trihalomethanes
Compounds present in the feed water that are formed by the reaction of
Chlorine and the organic material in the water. Activated carbon and
degasification can reduce THMs.
Tube Size
Tube is sized by its nominal outside diameter. For bioprocessing
equipment, tube does not include pipe.
Tumor
An abnormal growth of cells. Also defined as a circumscribed growth, not
inflammatory in character, arising from preexisting tissue, but
independent of the normal rate or laws of growth of such tissue, and
subserving no physiological function.
Tumor Pathogenesis
Morphological and physiological changes associated with tumor growth.
Tumor-Suppressor Genes
Genes that normally restrain cell growth but, when missing or inactivated
by mutation, allow cells to grow uncontrolled.
Turbidity
A suspension of fine particles that obscures light rays but requires many
days for sedimentation because of small particle size.
Turnover
Also known as "hand over" in the U.K. It is a formal transfer
of custody for a system or unit to another group, department, or operating
company.
Turnover Package (TOP)
A collection of pertinent design, construction, vendor, and operational
documentation. This collection of documentation is used for the
qualification and process validation activity, as well as reference and
single source information for the life of any particular system, process,
or piece of equipment.
Two-Bed Deionizer
Separate beds or layers of cation and anion exchange resins. Results in
lower purity than mixed-bed deionization, but provides higher capacity in
terms of throughput.
Tyrosine (Tyr)
A Phenolic alpha amino acid; a precursor of the hormones epinephrine,
norepinephrine, thyroxine, and triiodothyronine, and of the black pigment
melanin.