Biological pharmaceuticals, analytical

Ingels FM, Augustijns PF (2003) Biological, pharmaceutical, and analytical considerations with respect to the transport media used in the absorption screening system, Caco-2. J Pharm Sci 92 1545-58. 

Product development for biological pharmaceuticals might appear as a simple continuation of a research project after a sufficiently effective compound has been identified. From a scientific point of view there is no clear distinction between research and development. Until the clinical phase, product development utilizes the same basic skills and methods and - to a great extent - the experience of the same people who did the research. However, the rules change considerably as soon as innovative research turns into conservative testing of quality, safety and efficacy and into analytical and process development. 

An analytical technique for the separation and determination of solutes in any sample (such as biological, pharmaceutical, environmental, etc.). During the process, a liquid (the eluant) is pumped (usually at high pressure) through a porous, solid, stationary phase, which separates the solute species, and then into a flow-through detector. 

Ingels FM and Augustijns PF. Biological, Pharmaceutical, and Analytical Considerations with Respect to the Transport Media used in the Absorption Screening System, Czco-2. JPharm Set 2005 92(8) 1545-1558. 

Control of biological pharmaceutical products usually involves biological analytical techniques which have a greater variability than physic-chemical determinations. In-process controls therefore take on a great importance in the manufacture of biological pharmaceutical products. 

As many biologically important analytes do not exhibit efficient detection properties (UV or visible light absorption, fluorescence, or electrochemical activity), their detection limits are relatively low. For example, drugs with chiral centers exist naturally in racemic mixtures that are optically inactive due to the nearly equal proportion of the enantiomers. The determination of enantiomeric purity is of paramount importance in the pharmaceutical industry as each enantiomer may have different therapeutic characteristics. Currently, a method that offers multiple advantages for chiral separations is by converting enantiomers to diastereomers by precolumn derivatization with a pure fluorescent enantiomer. For instance, propranolol existing in racemic form may be analyzed by precolumn derivatization with (+ )-l-(9-fluorenyl)ethyl chloroformate. Well correlated calibration plots were found up to 400pmol and a reproducibility of <2% for each derivative. 

Classical, spontaneous Raman scattering is a powerful analytical tool that allows for the investigation of the qualitative and quantitative composition of biological, pharmaceutical, and environmental samples. The following discussion of NIR-Raman spectroscopy will begin with a general review of Raman spectroscopy, followed by a description of NIR-Raman, with further discussion about instrumentation and applications of the NIR-Raman technique. 

Diffuse reflectance spectroscopy is a versatile tool that allows us to accurately measure the flux per wavelength of light reflected in a scattered manner from a sample. Whether the sample be almost purely diffuse, as in a lightly packed powder, predominately specular, as in a burnished metal surface, or something in between, such as a glossy paint sample, diffuse reflectance spectroscopy tells much about the physical and chemical characteristics that are not available by other analytical means. In addition, diffuse reflectance spectroscopy in the visible region of the spectrum— that area between approximately 360 and 760 nm where our eyes are sensitive— allows quantitation of color measurement for biological, pharmaceutical, commercial, and artistic applications. 

Note Analytics for biological pharmaceutical products follow similar principles but utilize methods for in vitro or in vivo (animal model) bioactivity, electrophoretic and chromatographic methods, amino acid analysis, peptide mapping, sequencing, etc. for characterization. 

Highlights applications in analytical, organic, medicinal, biological, pharmaceutical, and drug analysis fields... 

The field of steroid analysis includes identification of steroids in biological samples, analysis of pharmaceutical formulations, and elucidation of steroid stmctures. Many different analytical methods, such as ultraviolet (uv) spectroscopy, infrared (ir) spectroscopy, nuclear magnetic resonance (nmr) spectroscopy, x-ray crystallography, and mass spectroscopy, are used for steroid analysis. The constant development of these analytical techniques has stimulated the advancement of steroid analysis. 

Pyrazol-3-ones are very versatile compounds and are important as products and intermediates in analytical, agricultural, biological, and pharmaceutical chemistry. 

Examples of SPE-GC of biological samples are few, while the usefulness of SPE-GC for the analysis of surface and drinking water has been demonstrated many times (133). This might be due to the fact that biological samples are often considerably more complex than environmental water samples. In addition, various biomedically and pharmaceutically interesting analytes will not be amenable to GC. Nevertheless, because many of the initial SPE-GC interfacing problems have now been solved (133), it seems appropriate and worthwhile to explore its utility in the bioanalytical field more thoroughly. 

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