Guide to BioTerminology 2nd edition - - BioPharm International

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Guide to BioTerminology 2nd edition

BioPharm International


DNA array Spots of DNA, oligonucleotide, or cDNA arranged on a solid support such as a glass or silicon "DNA chip" (or microarray), which is used for screening, se-quencing, genetic mapping, and so on.


Vitamin C (crystalline structure above) is a common excipient used in biopharmaceutical formulations to prevent oxidation of delicate proteins.
DNA fingerprinting Sequences of nucleic acids in specific areas (loci) on a DNA molecule are polymorphic, meaning that the genes in those locations may differ from person to person. DNA fragments can be cut from those sequences using restriction enzymes. Fragments from various samples can be analyzed to determine whether they are from the same person. The technique of analyzing restriction fragment length polymorphism (RFLP) is called DNA typing or DNA fingerprinting.

DNase Deoxyribonuclease, the enzyme that breaks up and destroys DNA sequences (a protective mechanism in higher organisms).

DNA vaccine A nucleic acid vaccine: Genes coding for specific antigenic proteins are injected to produce those antigens and trigger an immune response.

DOE Design of experiments; a term for experiments that are planned and analyzed using statistical design tools. A structured, organized method for determining the relationship between factors affecting a process and the output of that process. [ICH Q8]

dosage group A group of subjects in a clinical trial receiving the same dosage of a drug being tested.

downstream processing Bioprocessing steps following fermentation and/or cell culture, a sequence of separation and purification activities needed to obtain the required drug product at the necessary level of purity.

DQ Design Quaification; A documented review of the design, at an appropriate stage of stages in the project, for conformance to operational and regulatory expectations.

drug discovery Methods for identifying new therapeutic molecules. High-throughput techniques include combinatorial chemistry, genomics, and proteomics analysis as the starting point. Low-throughput methods include traditional disease research.

drug product The final dosage form of a pharmaceutical medicine containing drug substance formulated with selected excipients and packaged for the end user.

drug substance (or active pharmaceutical ingredient); the active drug chemical or biological substance in purified bulk form. The drug substance is further processed to derive a drug product.

due diligence A thorough study of a market, a potential product and its manufacturing requirements, a vendor or potential partner organization, or a process to determine its value, feasibility, or efficacy.

E

EBA Expanded-bed adsorption; a chromatography method that uses an upward flow of liquid in a column of suspended, dense chromatography beads to allow passage of crude, unclarified raw materials without clogging the chromatography medium.

efficacy The ability of a substance (such as a protein therapeutic) to produce a desired clinical effect; its strength and effectiveness; usefulness; the power to produce an effect.

efficiency of delivery The relative effectiveness of a drug delivery system.

elastomeric closure A rubber or rubber-like closure or stopper; a packaging component that may come into direct contact with the enclosed drug, which is usually an injectable.

electrolytes Ionized salts in body fluids; electrolyte solutions are solutions containing charged atoms or molecules.

electroosmotic The movement of a liquid out of or through a porous material or a biological membrane under the influence of an electric field.


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