Advisory Committee on Genetic Manipulation, the British equivalent to the US Recombinant DNA Advisory Committee (RAC).
Acetonitrile, the most frequently used solvent in HPLC, commonly used as an eluent.
active starting material The raw material that is identified as directly related to the active chemical comprising the product, and is defined at the
first stage during chemical synthesis at which part or most of the critical moieties are present. Defining active starting
material defines the step at which compliance with cGMP requirements begins during manufacturing. For biopharma-ceuticals,
this term is not used.
Ampules are one biopharmaceutical packaging alternative.
acute Describes a disorder as a one-time condition (an injury or infection), rather than as a chronic disease such as diabetes.
Absorption, distribution, metabolism, and excretion.
Adverse drug reaction, an undesirable effect that may be caused by a study drug; also "adverse events"
adsorption Adherence of molecules in solution or suspension to cells or other molecules—or to solid surfaces, such as chromatography
media. Compare to absorption.
Assays are the cornerstone of the analytical methods used in biopharmaceutical development.
adventitious agents Acquired, accidental contaminants in a cell line, such as viruses and toxins; often infectious agents.
adverse events (see also ADR) Undesired effects or toxicity in a patient due to exposure (often to a drug or medical device, but not limited to those).
Adverse events must be notified to the sponsor, who is required to perform a written investigation into the root causes, and
may need to take other corrective or preventive actions. (See complaints, CAPA)
aerobic Growing in the presence of oxygen. A strict aerobe grows only under such a condition.
affinity Attraction between particles or substances; relatively speaking, a measure of the attraction of one molecule toward another.
This scientist is using a benchtop bioreactor.
affinity chromatography A chromatographic method that makes use of the specific binding of one molecule to another; immunoaffinity chromatography
uses antibodies, for example, and metal affinity chromatography uses chelation.
affinity tag (or tail) An amino acid sequence added to a protein to facilitate purification by affinity chromatography.
agarose A polysaccharide (sugar) obtained from seaweed and used as a solidifying agent (agar) in microbial culture; also used in gel
aggregate A clustered mass, as of protein molecules; or to cluster together in such a way. Aggregates of cells (solid, fluffy, or pelletized)
can clog the pores of filters or other fermentation apparatus.
Alanine, one of over 20 naturally occurring amino acids.
albumins Protein constituents of blood plasma and serum also found in muscle, egg white, and milk.
alkylation The introduction, by substitution or addition, of an alkyl group into an organic compound; alkylating agents are various
substances that contain an alkyl radical and that can, therefore, replace a hydrogen atom in an organic compound; alkylation
is used to prevent refolding of already reduced proteins during peptide mapping.
alpha helix (α-helix) A coil or spiral element of protein secondary structure.