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Issue 5 2020

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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.

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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…

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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.