A vast majority of biotherapeutics are manufactured in either bacterial or mammalian expression systems. Metabolite profiling and substrate analysis during the fermentation process is critical to ensure optimal conditions for production and will trigger actions such as feed, improvement of oxygenation, adjustment of pH etc. The new Cedex Bio Bioprocess Analyzer from Roche (SIX: RO, ROG; OTCQX: RHHBY) is a continuous random-access analyser, enabling for a safe and reliable determination of chemical and biochemical parameters in aqueous solutions.
The compact desktop system is designed to fulfill the essential needs for metabolite screening and substrate analysis of bioprocesses. Its comprehensive testing capabilities include photometric testing and electrolyte testing. The measurement of up to 14 parameters simultaneously (out of 28 programmable tests) is possible per sample. The Cedex Bio Bioprocess Analyzer is easy to operate, enabling continuous loading and unloading of diverse cup types as well as on board dilution of highly concentrated samples. New parameters can be implemented by „plug and play" and a development channel for individual assay customization is planned.
"Bioprocess analytics are performed throughout the process from cell line development to large scale manufacturing of commercialized therapeutics. The majority of testing takes place during the upscale from plate-size to pre-clinical or early clinical studies supply - this is where the Cedex Bio Bioprocess Analyzer fits in perfectly. It is an accurate and reliable tool, providing bioprocess metabolite profiling, which is critical for the optimal production of biotherapeutics," stated Thomas Baier, Life Cycle Leader Custom Biotech at Roche Applied Science.
The Cedex Bio Analyzer was developed utilizing the proven cobas® Instrument technology from Roche. Assays for the determination of Glucose, Lactate, LDH, Ammonia, Na+, K+, Glutamine and Glutamate are available with the instrument. LDH as a parameter for cell death is unique in the metabolite profiling. Future parameters like an IgG measurement with comparable precision to HPLC analysis will be available, soon.
More information on the Cedex Bio Bioprocess Analyzer: http://www.roche-applied-science.com/custom-biotech/index.jsp?id=custom-biotech_090600.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80'000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.