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Science and risk-based specification setting for excipients

27 October 2020 | By , ,

Reducing unnecessary regulatory burden relating to excipients is important for any pharmaceutical manufacturer. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Kalyan Janjanam discuss a rational basis for controlling and specifying conflicting excipient attributes to avoid potentially tedious and complex regulatory processes.

Approval of regulatory starting materials

27 October 2020 | By

There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…

Using patent data to get ahead of the next pandemic

26 October 2020 | By

The COVID-19 pandemic initiated a huge pharmaceutical effort to tackle the virus at the cause, resulting in a surge in innovation in vaccines and antiviral drugs. This is an R&D trend that is likely to continue in an attempt to protect ourselves from future outbreaks. In this article, IP Analyst…

Biologics: a leadership journey

26 October 2020 | By

Behind every technological advance there is often a leadership story just as interesting. In this article, Ben Woollard highlights key leadership behaviours that have been fundamental in biological innovation and suggests how businesses can implement these attributes to strive forward in a new era of biologics.

Expert view: Maximising treatment efficacy

23 October 2020 | By

As a world-leading drug device combination solutions specialist, our purpose of putting patients first enables us to design and manufacture devices that maximise treatment efficacy.

Your endotoxin experts

21 October 2020 | By

Specialising in chromogenic and turbidimetric reagent technologies, ACC has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 45 years.