Case Study: a major pharmaceutical company achieves expanded QbD process monitoring and fewer quality deviations with Seeq

Major Pharmaceutical Company - Customer Case Study

A major pharmaceutical company worked to improve quality by design (QbD) modeling for a continuous drug product wet granulation process, with the challenge of avoiding failed batches and preserving process knowledge as products moved from R&D into commercial production. The company needed a better way to account for interactions among critical process parameters so it could reduce deviations and maintain product quality at scale, using Seeq Corporation’s analytics platform.

Using Seeq Corporation, the company built a multivariate QbD process model from DOE data, time-warped signals to align sensor data, and filtered the results to steady-state operation before applying prediction models for critical quality attributes. Seeq then helped deploy the design space into commercial production for online monitoring, automatically flagging deviations with capsules and expanding the process design space to minimize out-of-specification product and reduce costly quality deviations.