ABSTRACT

INTRODUCTION Pharmaceutical and biotechnology companies are placing increasing pressure on their development to complete more work with less resources. These companies want to identify and solve issues with compounds at an earlier stage to minimize development costs and time ( 1 ). Additionally, quality by design (QbD) initiatives are resulting in more fundamental studies on drug products entering late-stage development in order to understand and quantify the robustness of process conditions. For those activities that are routine and repeated frequently, the use of automation can signifi cantly improve effi ciency, throughput, and impact productivity. Stress-testing studies (also generally known as forced degradation studies) yield data that are essential to understanding the degradation chemistry of drug molecules that are in the development phase. These studies are logical places to consider automation since all drug compounds proceed through essentially the same experimental workfl ow to identify conditions that lead to degradation and to identify degradation products.