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Analytical techniques

 

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PAT Series: Predictive monitoring and control approaches in biopharmaceutical manufacturing

3 September 2015 | By Cenk Undey, Tony Wang, Bryan Looze, Yingying Zheng and Myra Coufal - Amgen

Predictive monitoring is a key feature of biopharmaceutical manufacturing; making predictions about the key process end points such as process performance indicators or quality attributes using a process model offers the unique advantages of process improvement and optimisation, and helps give insights into variability.

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Revolutionising Raman with the transmission technique

3 July 2015 | By Julien Villaumié and Hilary Jeffreys, Actavis

All regulatory agencies require that manufacturers accurately determine the amount of drug in a medicinal product so that the product can be deemed fit for patients. This forms part of batch release testing performed by Quality Control (QC) laboratories. The drug assay and/or content uniformity of the dosage units is…

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Universal detection in high performance liquid chromatography

3 July 2015 | By David P. Elder, Phil Borman and George Okafo - GlaxoSmithKline

The most commonly used analytical technique for the testing of drug molecules is reversed-phase high performance liquid chromatography (RP-HPLC) with ultraviolet (UV)/visible detection. However, one of the biggest constraints affecting UV/visible detectors is their inability to generate adequate sensitivity for analytes lacking a suitable UV chromophore.

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Fast quantitative 2D NMR for quantifying analytes in complex mixtures

3 July 2015 | By Patrick Giraudeau, University of Nantes

Nuclear magnetic resonance (NMR) spectrometry is a major quantitative tool in pharmaceutical analysis, owing to its extremely high accuracy. However, absolute quantification in complex mixtures is often hampered by spectral overlap which considerably reduces the quantitative performance of NMR.