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The importance of disaccharide excipients in biologics

17 February 2021 | By , ,

Many biologic formulations use a variety of high-purity injectable grade disaccharide excipients to ensure functionality and stability of the final product. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Thontesh GC explore the use of these sugars in the stabilisation of biologics and provide recommendations to manufacturers for enhancing…

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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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European Pharmaceutical Review Issue 5 2020

16 October 2020 | By

In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…