Inactive

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) / Division of Genetic and Molecular Toxicology requires brand name or equal Bioprofile Flex2 System bio... The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) / Division of Genetic and Molecular Toxicology requires brand name or equal Bioprofile Flex2 System bioanalyzer (model number: 57805) capable of monitoring metabolites in cell culture media. The instrument is required to understand the effects on stem cell products cultured in a bioreactor system. Optimal expansion of cells in a bioreactor requires monitoring of parameters such as pH, dissolved gases like CO2 and O2, and metabolites like glucose, lactate, and glutamine. The Office does not currently have the ability to monitor metabolites in culture media and needs to purchase a system that can monitor those critical parameters during cell culture in bioreactors.