Application of Microarrays in Process Analytical Technologies A First Step Towards Real Time Product Release

Summary

Full implementation of Process Analytical Technologies (PAT) in a biopharmaceutical process makes real time product release feasible.¹

On line process monitoring with near infrared (nIR) spectroscopy gives insight in product quality as it is formed.

Extensive process understanding is necessary to identify critical quality attributes. By monitoring these attributes with nIR, real time quality assurance and ultimately real time product release can be achieved.

Application of microarrays during process development helps to gain insight in biological processes involved in product formation, increasing process understanding.

The NVI is working on the implementation of this approach on the cultivation process step for the manufacturing of a whole cell vaccine against whooping cough disease, caused by the Bordetella pertussis bacterium.