A new, automated modular analyzer from Nova Biomedical provides a comprehensive analysis for cell culture processing. BioProfile FLEX provides up to 16 key cell culture attributes, including glucose, lactate, glutamine, glutamate, ammonium, PCO2, PO2, pH, sodium, potassium, calcium, osmolality, cell density/viability, and phosphate or total protein in a single, easy-to-use workstation. This comprehensive test menu provides immediate access to the critical information required to optimize product quality and yield.
BioProfile FLEX is provided in one modular field upgradeable platform to accommodate the needs of R&D through GMP manufacturing applications. The system can be configured in various combinations from one to four modules, building on the base chemistry/gas module and adding any combination of osmolality, cell density/cell viability, and phosphate or total protein.
Taking the place of up to five separate analyzers, BioProfile FLEX can reduce cell culture analysis time, labor, and operating costs by consolidating multiple analyzers into a single workstation. This compact analyzer uses a small, 1 mL sample to conserve cell culture mass and end product, and provides a fast, six- minute analysis that saves as much as 30 minutes per sample over multiple instrument analyses. One intuitive user interface simplifies operation. One data source eliminates transcription and streamlines data collection, archiving, and regulatory analysis. One validation simplifies the validation process.
BioProfile FLEX offers multiple sampling options, including individual sampling via a syringe/docking device, automated batch sampling using a 20-position sampling tray, and on-line automated sampling from up to four bioreactors. The analyzer features a Microsoft Windows XP-based interface that can be operated from an external PC with keyboard and mouse, or touch screen computer. Data may be automatically exported into most common formats including Microsoft Excel. All BioProfile FLEX software is fully compliant with FDA 21 CFR Part 11 Electronic Signatures and Electronic Records.
By consolidating all tests into a single instrument, BioProfile FLEX facilitates the task of data sharing and interoperability with other devices. Data can be easily exported to OPC compliant devices such as bioreactor controllers, overall existing IT infrastructure, LIMS, Plant Manager, or data historians for feedback control, analysis, and record keeping. BioProfile FLEX tracks the FDA’s PAT initiative to measure, communicate, capture, and control bioprocess data for cell culture or fermentation.