By Daniel Galbraith, Director of Global Product Characterization, MilliporeSigma
The biopharma industry is constantly advancing and innovating, but what does this mean for processes? Standard approaches are not viable long term due to regulatory changes, more cutting-edge drugs, and new markets. Stability testing is one area that may be considered a victim of the status quo, and this can be misleading because higher expectations are being placed on data quality. Specifically, the regulatory demands are focused on extensive and in-depth analysis more than ever before. This amplifies the responsibility of drug developers to evaluate testing and optimize processes, resulting in complex processes for manufacturers to confirm the quality, efficacy, and safety of drug formulations. A framework for stability studies exists; however, specific testing requirements vary considerably between markets. So, how can drug developers mitigate risks, avoid costly mishaps, and stay current? Let’s explore these questions and their impacts.