Abstract

A New Approach towards Chromatographic Method Development for Pharma Industry

K K Bhagchandani, Senior Director, Advanced Chemistry Development Inc

Pharmaceutical or chemical industry has been producing one of the purest and safe chemical compounds for a long time, however they are highly regulated to ensure this keeps happening. All these companies are hence working/dealing with Impurities (and degradents) as a routine. On one hand it has pressures due to costs and faster turnaround and on other hand it gets pushed for quality of methods which they are generating during drug development! In addition, methods are expected to be robust and should not fail with small changes in conditions!

For many years’ statistical tools have been used to address the challenge of chromatographic method development; but it has only helped users upto a certain extend only. The major missing piece; for addressing this issue was deployment of chemical understanding before taking help of statistical tools in a seamless manner. QbD has been mandated for researchers, to generate best methods rationally! In order to achieve this; it has requirements from both sides such as ‘rational selection of conditions’ and Multi-variate analysis’.  The aim is to find the best combination of variables which are most likely to succeed and be robust. Now, humanly it is resource-intensive and time-consuming to work with several variables at the same time; hence they need newer tools for Simulations and informatics to achieve this goal in a much fatser & efficient way. This presentation describes our attempts to apply software tools to streamline method development (following the principles of QbD) to alleviate the increased resource burden. In addition, analytical QbD could significantly reduce the efforts relating to post approval variation.