Comparability Studies  

Throughout the lifecycle of a biopharmaceutical product, it is often necessary to make changes to the manufacturing process. These changes may improve the consistency of the process, increase the scale or yield to meet supply needs, involve transfer to a new facility or equipment, and/or be designed to improve product quality.  

When manufacturing changes occur, it is necessary to demonstrate that product quality is not adversely impacted, and that the safety and efficacy established with prior process versions will be maintained with material from the post-change process. These requirements are fulfilled by performing a comparability exercise following the guidelines of ICH Q5E.  

A comparability exercise is designed to evaluate product quality attributes using a set of analytical tests, and typically includes release assays, extended characterization methods and analysis of stressed samples.  

The design and rigor of the comparability exercise is guided by the potential impacts of process changes and considers the phase of drug development. 

We have the comprehensive instrumentation, methodologies and experience to support comparability evaluations across all phases of the clinical and commercial lifecycle.