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A Guide to the Biopharmaceutical Lexicon

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A Guide to the Biopharmaceutical Lexicon [ BIOTERMINOLOGY ] 2018 Edition A GUIDE TO THE BIOPHARMACEUTICAL LEXICON magentablackcyanyellow ES1010980_BPlexicon0218_cv1.pgs 01.26.2018 15:53 ADV [ BIOTERMINOLOGY ] BIOTERMINOLOGY AND DEFINITIONS acceptance of the results of analytical A procedures which the drug substance or absorption Removal of a particular drug product or materials at other stages molecule from a sample by accumulation of their manufacture should meet. [From into a bound water volume such as might ICH Q6B] be present in a densely fibrous material. In ACN Acetonitrile; the most frequently pharmacology (and more specifically phar- used solvent in HPLC, commonly used as macokinetics), absorption is the movement an eluent. of a drug into the bloodstream. Absorp- acidic variant A product variant that tion involves several phases. First, the exhibits a more negative charge character drug needs to be introduced via a route of by IEX or CE than the primary biotherapeu- administration (oral, via the skin, etc.) and tic form. in a specific dosage form such as a tablet, active starting material The raw ma- capsule, and so on. (See adsorption). terial that is identified as directly related accelerated stability tests Studies to the active chemical comprising the prod- in which the product is stored under stress uct, and is defined at the first stage during conditions (for example, 45 °C and high chemical synthesis at which part or most of humidity over three to six months) and the critical moieties are present. Defining observed for signs of degradation; used to active starting material defines the step at predict long-term storage patterns. which compliance with cGMP requirements acceptance criteria Numerical limits, begins during manufacturing. For biophar- ranges, or other suitable measures for maceuticals, this term is not used. Following acronyms that appear in brackets throughout the guide represent the sources of definitions: • FDA PHS Act definition is the one that appears in the US Public Health Service Act. • FDA QSG definition is the one that appears in the US FDA’s Quality Systems guidance. • ICH Q6B definition is the one that appears in the International Conference on Harmonization (ICH) Q6B guideline, “Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.” • ICH Q8 definition is the one that appears in the ICH Q8 guideline, “Pharmaceutical Development.” • ICH Q9 definition is the one that appears in the ICH Q9 guideline, “Quality Risk Management.” • IC H Q11 under review; definition is the one that appears in the ICH Q11 guideline, “Development and Manufacture of Drug Substances (chemical entities and biotechnical/biological entities).” • ISO 14971 Refers to the International Organization for Standardization’s standard 14971, “Medical Devices—Application of risk management to medical devices.” • ISO/IEC Guide 51 Refers to the the joint ISO and IEC (International Electrotechnical Commission) publication, “Safety aspects—Guidelines for their inclusion in standards.” • ISO Guide 73 Refers to ISO Guide 73, “Risk management—Vocabulary—Guidelines for their use in standards.” A Guide to the Biopharmaceutical Lexicon • 2018 3 magentablackcyanyellow ES1010995_BPlexicon0218_003.pgs 01.26.2018 15:59 ADV [ BIOTERMINOLOGY ] acute Describes a disorder as a one- time condition (an injury or infection), rather than as a chronic disease such as diabetes. ADME Absorption, distribution, metabo- lism, and excretion. adjuvant A chemical agent added to vaccines to boost the immune response to the vaccine antigen. ADR Adverse drug reaction, an undesirable One of the most frequently used effect that may be caused by a study drug (see solvents in chromatographic analysis is ACN, acetonitrile. also adverse events). adsorption Adherence of molecules affinity tag (or tail) An amino acid in solution or suspension to cells or other sequence added to a protein to facilitate molecules—or to solid surfaces, such as chro- purification by affinity chromatography. matography media. Compare to absorption. agarose A polysaccharide (sugar) obtained adventitious agents Acquired, accidental from seaweed and used as a solidifying agent contaminants in a cell line, such as viruses (agar) in microbial culture; also used in gel and toxins; often infectious agents. electrophoresis. adverse events (see also ADR) Unde- aggregate A clustered mass, as of protein sired effects or toxicity in a patient due to molecules; or to cluster together in such a exposure (often to a drug or medical device, way. Aggregates of cells (solid, fluffy, or pel- but not limited to those). Adverse events must letized) can clog the pores of filters or other be notified to the sponsor, who is required to fermentation apparatus. perform a written investigation into the root Ala Alanine; one of more than 20 natu- causes, and may need to take other corrective rally occurring amino acids. or preventive actions. (See complaints, CAPA) albumins Protein constituents of blood aerobic Growing in the presence of oxygen. plasma and serum also found in muscle, egg A strict aerobe grows only under such a white, and milk. condition. alkylation The introduction, by substitution affinity Attraction between particles or or addition, of an alkyl group into an organic substances; relatively speaking, a measure of compound; alkylating agents are various the attraction of one molecule toward another. substances that contain an alkyl radical and affinity chromatography A chromato- that can, therefore, replace a hydrogen atom graphic method that makes use of the specific in an organic compound; alkylation is used to binding of one molecule to another; immuno- prevent refolding of already reduced proteins affinity chromatography uses antibodies, for during peptide mapping. example, and metal affinity chromatography alpha helix (α-helix) A coil or spiral ele- uses chelation. ment of protein secondary structure. 4 2018 • A Guide to the Biopharmaceutical Lexicon magentablackcyanyellow ES1010994_BPlexicon0218_004.pgs 01.26.2018 16:00 ADV [ BIOTERMINOLOGY ] amino acid analysis Hydrolysis of a protein analyze or characterize a mixture, a compound, or peptide into its individual residues (free amino or an unknown material. acids), followed by chromatographic separation anion A negatively charged ion (having and UV-visible detection for analytical purposes. more electrons than protons). amino acids A class of 20 naturally oc- anion exchange chromatography A curring hydrocarbon molecules that combine method for separating molecules on the basis of to form proteins in living things. They include negative charge; it can use strong or weak anion alanine (A), arginine (R), exchangers. asparagine (N), aspartic acid (D), cysteine (C), anneal Complementary sequences of glutamic acid (E), glutamine (Q), glycine (G), single-stranded DNA or RNA are paired by histidine (H), isoleucine (I), leucine (L), lysine hydrogen bonds to form a double-stranded (K), methionine (M), phenylalanine (F), proline polynucleotide. (P), serine (S), threonine (T), tryptophan (W), annual review An evaluation, conducted tyrosine (Y), and valine (V). (Those are the at least annually, which assesses the quality so-called normal amino acids; others have standards of each drug product to determine the been synthesized and are used in medicinal need for changes in drug product specifications chemistry.) They are incorporated into proteins or manufacturing or control procedures. [From by transfer RNA according to the genetic code. FDAQSG] amorphous Having no apparent shape or anodes Positive electrodes; negative ions order; non-crystalline. (anions) migrate carrying electric current toward ampholyte An electrolyte that can be either positive anodes. positively or negatively charged, depending on Amino acid analysis can be used to the pH of its medium. quantitatively determine the amount of amphoteric A substance that has both acid protein and the proportions of amino acids in a sample. The Waters UPLC and base properties; amphoteric molecules can Amino Acid Analysis Solution is a accept or donate protons to act as an acid or a turnkey chromatographic system that provides accurate, high-throughput base. amino acid analysis. ampule A small, sterile glass vessel with an airtight seal that contains a single drug dose. amyloid Insoluble fibrous protein aggregates sharing specific structural traits. Abnormal accumulation of amyloid in organs may lead to amyloidosis and may play a role in various other neurodegenerative diseases. anaerobic Growing in the absence of air or oxygen. Some anaerobic organisms are killed by brief exposure to oxygen, whereas it may simply retard or stop the growth of others. analytical methods Processes used to A Guide to the Biopharmaceutical Lexicon • 2018 5 magentablackcyanyellow ES1011024_BPlexicon0218_005.pgs 01.26.2018 16:12 ADV [ BIOTERMINOLOGY ] antibody An infection-fighting protein mol- antisense oligonucleotides Antisense ecule that tags, neutralizes, and helps destroy oligonucleotides interact with complementary foreign microorganisms or toxins. Also known strands of nucleic acids, modifying expression as immunoglobulins, antibodies are produced of genes. by the immune system in response to antigens. API Active pharmaceutical ingredient; Antibodies are composed of four subunits: two the chemical entity that has the drug activity heavy chains and two light chains. Each sub- and structure, but is not yet formulated with unit contains a constant region and a variable excipients. region. The constant regions remain the same aprotinin
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