CHEMOMETRIC PROCESS ANALYTICAL TECHNOLOGY (PAT) APPLICATIONS IN BIOPROCESS ENGINEERING

摘要

The production process of an active pharmaceutical ingredient (API) by fermentation in an industrial environment was analysed using process analytical technologies. The Food and Drug Administration’s (FDA) process analytical technology (PAT) initiative is intended to be a collaborative effort with industry to promote the integration of new manufacturing technologies into pharmaceutical production. Within the PAT framework the aim is to design, develop and operate processes consistently to ensure a predefined quality at the end of the manufacturing process. Several case-studies are discussed in which combining chemometrics methods with NIR spectra from samples in different process stages leads to increased process understanding and process control of an API production process.