Topic

Articles

The accuracy of prediction models based on spectroscopic measurements can be influenced by a variety of factors, including aging equipment. Continuous monitoring is key to managing the PAT model lifecycle and ensuring that changes over time do not negatively affect prediction model performance.

Process Analytical Technology (PAT) Model Lifecycle Management

John Wasylyk, a principal scientist at Bristol-Myers Squibb in New York, New York, has been using quality by design (QbD), Raman spectroscopy, and Fourier transform infrared (FT-IR) spectroscopy in process development as well as for at-line and on-line monitoring of active pharmaceutical ingredient (API) crystallization. Here, he discusses the advantages, limitations, and challenges of these techniques.

Quality by Design (QbD)