Process Analytical Technology (PAT) Applications in Bioprocess Engineering

The production process of an active pharmaceutical ingredient (API) by fermentation was analysed using process analytical technologies (PAT). FDA 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 understanding and process control of an API production process. In this paper the use of PAT as a tool to operate an important shift in quality control efforts is illustrated, showing that quality should not be tested only on final products but in-process to increase QA.