ICH The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; a project bringing together the regulatory authorities of Europe, Japan, and the United States with experts from the pharmaceutical
industry to discuss scientific and technical aspects of product registration. Its purpose is to recommend ways to harmonize
the technical guidelines and requirements for product registration and reduce or obviate the need to duplicate testing during
development of new medicines.
Insulin, a hormone, was the first biopharmaceutical approved by FDA.
Ion-exchange chromatography; sometimes abbreviated IEX, a liquid chromatographic technique based on the electrical phenomenon of ion exchange. The amphoteric
nature of proteins can be exploited to bind them in cation-exchange (binding positively charged proteins) or anion-exchange
(binding negatively charged proteins).
Isoelectric focusing; analytical separations in an electrical field through a pH gradient (therefore based on the net charge of the molecules);
usually done in bioanalysis at a neutral pH so that proteins (for example) will move under the influence of the electric field
until their net charge is zero (their isoelectric point, pI). IEF is a specialized form of electrophoresis that can be adapted
to the capillary format.
Isoleucine; one of over 20 naturally occurring amino acids.
immortalize To alter cells (either chemically or genetically) so that they can reproduce indefinitely.
immunoassay An antibody-based test used most often for bioanalytical purposes.
immunodetection A process that identifies and quantifies specific biological substances, such as antigens.
immunogen A substance that provokes an immune response — that is, the body recognizes it as a foreign agent that must be expelled or
immunoglobulin A protein produced by plasma cells that fights infection or takes part in various immune responses. Immunoglobulins bind with
other molecules with a high degree of specificity; divided into five classes (IgM, IgG, IgA, IgD, and IgE) on the basis of
structure and biological activity.
Immunohistochemistry The staining of histology preparations using chromagen linked antibodies to specifically stain for specific proteins in
a histology section/slide.
impurity A foreign agent or material either introduced as part of processing (such as buffers or salts added during chromatography)
or intrinsic to the nature of bioprocessing (such as product variants and cellular debris).
in silico Studies done "in the computer." Modeling a protein in silico refers to providing an integrated, computerized view of the molecule.
in vitro Performed using laboratory apparatus rather than a living animal.
in vivo Involving living animals or humans as test subjects.
inclusion bodies Discrete structures (virions, viral components, cellular material, aggregated proteins) present either normally or abnormally
IND The Investigational New Drug application, by which a company files a request with FDA for permission to expose its experimental drug to patients or healthy
human volunteers. This application must be filed for each individual clinical study performed, Phases 1–3.
indications A collection of symptoms or one disease type; the condition that a drug is intended to treat. The condition or symptoms a
particular drug is used to treat are determined either by evidence of positive effect or knowledge of the cause of the disease.
infusion Introducing a solution into the bloodstream or another solution; also refers to the solution itself, such as a drug formulation,
in-house Not outsourced: work done by a company's own employees.
inoculate To introduce cells into a culture medium; also to introduce material to sensitize patients (as in vaccination).