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Can calorimetry provide accurate estimates of long‑term stability for monoclonal antibodies?

3 September 2019 | By

Differential scanning calorimetry (DSC) has been one of the most widely used techniques to characterise the temperature stability of monoclonal antibodies (mAbs) and provide important information in formulation optimisation. However, despite its widespread use, not all the information contained in DSC data, especially denaturation kinetics, is routinely extracted. In this…

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Advances in automated performance verification for UV/VIS spectrophotometers

22 August 2018 | By Mettler-Toledo

Regulated environments require performance verification (qualification) of UV/VIS spectrophotometers on a regular basis. Instrument performance is the main factor directly affecting the accuracy and repeatability of measurements. Hence, it is important that this is regularly monitored and that documentary evidence is provided. Optical performance verification is conducted to the widely…

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Isothermal calorimetry in the pharmaceutical sciences

13 June 2013 | By Anthony E. Beezer and Simon Gaisford, UCL School of Pharmacy

Fifty years ago, isothermal microcalorimetry (IMC) was a means to determine thermodynamic data (principally values for enthalpies of formation or reaction to assist in the calculation of Gibb’s Free Energy functions and entropies). These data were used in the compilation of tables of thermodynamic values, for use in evaluating, inter…

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Fast-scan differential scanning calorimetry

2 August 2008 | By

Differential scanning calorimetry (DSC) is a widely used technique within the pharmaceutical industry because the range of phase transitions it can measure usually allows near complete physical characterisation of a new active principal early during preformulation. In addition, because DSC measures a property change that is ubiquitous† (heat) there are…

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Thermal analysis and calorimetry: latest developments

19 March 2008 | By Danielle Giron, Chemical Research & Development, Novartis Pharma AG, Basel, Switzerland

Thermal analysis techniques cover all methods in which a physical property is monitored as a function of temperature or time, whilst the sample is being heated or cooled under controlled conditions. Calorimetric methods measure the energy involved in every process. The quicker new developments attain the market, such as the…

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Calorimetry for amorphous content quantification

23 May 2007 | By Simon Gaisford PhD and Rita Ramos PhD, School of Pharmacy, University of London

In the previous article (European Pharmaceutical Review, Issue 2, 2007) an introduction to calorimetry was given and its application to polymorph characterisation, discussed. Another area of application of growing importance is quantification of (usually small) amorphous contents. A requirement to demonstrate the presence or absence of amorphous material is becoming…