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 …

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

A novel online sensor system for noninvasive and continuous monitoring of cell growth in
shake flasks is described. The measurement principle is based on turbidity measurement by …

It has been more than a decade since the concept of Quality by Design (QbD) was
introduced to the biotech industry. Considerable efforts have been spent by the major …

摘要为了实时, 原位和非接触测量工业生产过程中封闭管道系统内透明, 半透明液体折射率,
提出了一种简单的基于玻璃管壁光学特性的液体折射率测量方法. 该方法通过涂覆在玻璃管壁外 …

Although shake flasks are most widely used for microbial cultivations, noninvasive on-line
sensors for these systems are still limited compared to bioreactors. While pH and dissolved …

Rapid development of biotechnology resulted in increasing need for bioprocess monitoring
and control. Efficient process control allows optimization of process efficiency and …

This work studies the problem of design of nonlinear observers in the presence of
exogenous disturbances. In particular, the present work proposes a systematic design …

This study developed an artificial neural network (ANN) to estimate the growth of
microorganisms during a fermentation process. The ANN relies solely on the cumulative …

In recent times, there is a growing need in the biopharmaceutical industry for improved
process understanding to enhance productivity and product quality. Process Analytical …