Utilizing Roche Cedex Bio analyzer for in process monitoring in biotech production

Introduction One task during development and control of bioprocesses used for production of recombinant proteins is to deliver fast, accurate and reliable analytical process data. Monitoring of nutrients and metabolites in animal or bacterial cell culture is essential to avoid limitations or toxic accumulation during fermentations that can effect cell growth, viability, product yield and quality. Within certain fermentation processes low levels of nutrients trigger in-process actions such as feed. Other parameters are used to track culture reproducibility and to gain process understanding for process development and validation. Typical parameters in mammalian cell culture are glucose, lactate, glutamine, glutamate, ammonia, sodium and potassium. Therefore it is common to use multianalyzer systems based on enzymatic-dependent biosensors and ionselective potentiometry. Furthermore the release of lactate dehydrogenase (LDH) into the fermentation media is used as an indicator of cell death during fermentation processes therefore a 96-well based photometric assay is used . The measurement of product titer like IgG is needed to track productivity or yield during fermentation and protein purification processes and is mostly done by HPLC methods. One major motivation for this new Bioprocess analyzer lies within the eminent issues of enzyme membrane based analytical technology such as: short life cycles as well as poor or changing quality of the enzyme membranes, high material costs, non-linearity of measurements and in particular insufficient sensitivity and accuracy. Additionally the laborious maintenance required to operate different analytical devices and labor intensive sample management as well as manual steps to avoid operator dependent variability needed to be reduced.