Near-infrared (NIR) spectroscopy is a fast and non-destructive analytical technique that
offers many advantages for a broad range of industrial applications. In this work, we …

Abstract The “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st
Century—A Risk Based Approach” initiative announced by the FDA in August 2002 to …

This article provides a perspective on control and operations for biopharmaceutical
manufacturing. Challenges and opportunities are described for (1) microscale technologies …

In the past decades, biotechnology has exploded to a cutting edge industry and its
economical significance is exponentially growing. Bioprocess efficiency, productivity and …

Near‐infrared (NIR) spectroscopy can potentially provide on‐line information on substrate,
biomass, product, and metabolite concentrations in fermentation processes, which could be …

Classical culture media, as well as domestic and/or industrial wastewater treated by
biological processes, have a complex composition. The on-line and/or in situ determination …

Implementing real‐time product quality control meets one or both of the key goals outlined in
FDA's PAT guidance:“variability is managed by the process” and “product quality attributes …

The use of in‐situ near infrared spectroscopy (NIRS) as a tool for monitoring four key
analytes in a CHO‐K1 animal cell culture was investigated. Previous work using on‐line …

The biopharmaceutical industry is at a turning point moving toward a more customized and
patient‐oriented medicine (precision medicine). Straightforward routines such as the …

Bioreactors are closed systems in which microorganisms can be cultivated under defined,
controllable conditions that can be optimized with regard to viability, reproducibility, and …