Case Study: Ono Pharmaceutical achieves robust quality control in manufacturing with JMP

A statistical approach helps Ono Pharmaceutical build quality controls directly into manufacturing methods

Ono Pharmaceutical needed to adapt its new process development to ICH guidelines that recommend statistical methods for pharmaceutical quality control, while managing many interacting manufacturing factors. The company turned to JMP to help model these relationships and design robust manufacturing operations that could consistently meet quality goals.

Using JMP, Ono Pharmaceutical identified the factors affecting product quality, visualized interactions with contour plots, and optimized its design space to reduce impurities and stabilize results. The solution helped the company set better manufacturing parameters and build quality controls directly into the process, resulting in highly robust processes and broader use of statistical analysis across research teams.

Ono Pharmaceutical

Tatsushi Murase

Chemical Process R&D Researcher, CMC and Production HQ