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European Pharmaceutical Review Issue 5 2019

30 October 2019 | By

Within this issue is an analysis of the impacts that low temperature can have on protein aggregation, a discussion on maintaining the safety and quality of medicines when delivered using drones and an exploration of chromatographic techniques used to identify impurities in radiopharmaceuticals. Other articles focus on regulatory non-compliance, excipients…

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Biofluorescent particle counter-based real-time feedback and control of processing conditions

3 September 2019 | By , , , , , , , , ,

Biofluorescent particle detectors offer a fundamentally different way of enumerating microbes present in an environment, as compared to traditional growth-based methods. Here, the Process and Environmental Monitoring Methods (PEMM) group shares information about the technology and applications for real-time biofluorescent particle detection methods and how they help to address major…

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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…