Near-Infrared Spectroscopy to Determine Residual Moisture in Freeze-Dried Products: Model Generation by Statistical Design of Experiments.

Moisture content (MC) is a critical quality attribute of lyophilized biopharmaceuticals and can be determined by near-infrared (NIR) spectroscopy as nondestructive alternative to Karl-Fischer titration. In this study, we create NIR models to determine MC in mAb lyophilisates by use of statistical design of experiments (DoE) and multivariate data analysis. We varied the composition of the formulation as well as lyophilization parameters covering a large range of representative conditions, which is commonly referred to as "robustness testing" according to quality-by-design concepts.

Evaluation of Pyrolysis Oil as Carbon Source for Fungal Fermentation.

Pyrolysis oil, a complex mixture of several organic compounds, produced during flash pyrolysis of organic lignocellulosic material was evaluated for its suitability as alternative carbon source for fungal growth and fermentation processes. Therefore several fungi from all phyla were screened for their tolerance toward pyrolysis oil. Additionally and , both established organic acid producers, were chosen as model organisms to investigate the suitability of pyrolysis oil as carbon source in fungal production processes.