Guide to BioTerminology 2nd edition - - BioPharm International


Guide to BioTerminology 2nd edition

BioPharm International

Insulin, a hormone, was the first biopharmaceutical approved by FDA.
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.

IEC 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).

IEF 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.

Ile 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 destroyed.

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 within cells.

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, when infused.

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).

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