Sunil Kumar Nataraj (DFE Pharma)

article

The importance of disaccharide excipients in biologics

17 February 2021 | By Bastiaan Dickhoff (DFE Pharma), Sunil Kumar Nataraj (DFE Pharma), Thontesh GC (Apotex Pharmaceuticals)

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…

article

Science and risk-based specification setting for excipients

27 October 2020 | By Bastiaan Dickhoff (DFE Pharma), Kalyan Janjanam (Epic Pharma), Sunil Kumar Nataraj (DFE Pharma)

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.