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Developments in stability testing and evaluation

4 September 2019 | By , , , , , , , ,

The Joint Pharmaceutical Analysis Group (JPAG) held a stability meeting at the Royal Society of Chemistry’s headquarters in London earlier this year. Attended by 65 delegates, its focus was on developments in stability testing and evaluation. Here follows a summary of the presentations made at the meeting.

China and the evolving regulatory landscape

4 September 2019 | By

The Chinese pharmaceutical industry has been lagging behind in terms of drug development and bringing new products to the market. In this article, Megha Baruah discusses the changes the National Medical Products Administration (NMPA) of China is making to existing policies and informs on guidance documents that have been released…

ICH Q10 knowledge management

3 September 2019 | By

The efficient handling of information and resources is key for achieving success within a commercial organisation. Against the backdrop of ICH Q10 – the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Christian Rack discusses five things you can implement right now to…

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…

How tablet formulation can impact production

3 September 2019 | By

Transforming a formulation into a successful solid dose product is a complex process that involves many considerations. Given the ever-growing demand for increased tablet quantities and the goal of reducing time to market, Rob Blanchard explains how the pressure is on manufacturers to find innovative processes to improve production efficiency.

The future of tamper-proof pharmaceutical packaging

3 September 2019 | By

In February this year the EU Falsified Medicines Directive (FMD) came into effect. Rich Quelch assesses this latest regulatory attempt to rid the supply chain of dangerous falsified products and reflects on the industry’s need to keep ahead of the game to future-protect itself.

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…