Developed in conjunction with leading biotechnology companies, BioProfile Analyzers provide those assays necessary to address the testing requirements from small to large scale bioprocessing, encompassing:

• Research and Development
• Process Development
• Pilot Plant
• Production

Applications of the BioProfile include:

• Monitoring the progress of bioreactor runs
• Determining the consumption and production of key metabolites
• Identification of growth-limiting nutrients
• Design of feeding strategies
• Calibration of bioreactor probes
• Measurement of cellular respiration
• Balancing media electrolytes
• Control levels of waste product

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BioProfile's comprehensive test menus allow consolidation of testing into a single analyzer. This results in significant time and labor savings, as well as real-time process control capabilities.

BioProfile's fast analysis time and consolidated testing offer the following advantages:

• Eliminate the requirement for taking multiple samples and large sample volumes from reactor vessels
• Provide real-time access to test results, enabling real-time process control
• Substantially decrease labor, capital equipment, and reagent costs
• Improve the ability to effectively monitor and control bioreactor processes
• Improve process reliability and reproducibility
• Speed optimization of feeding strategies
• Improve manufacturing yield and quality

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ELECTROCHEMICAL (BIOSENSORS)
Potentiometric Electrodes (pH, PCO2, NH4+, Na+, K+, Acetate)
Potentiometric-based electrodes measure charged ions and have a sensing membrane that is selective to the ion being measured. They develop a voltage proportional to the concentration of the measured ion.

Amperometric Electrodes (PO2, Glucose, Lactate, Glutamine, Glutamate)
The basic amperometric electrode is the oxygen electrode, which consists of an oxygen-permeable membrane covering a platinum cathode.

Glucose, lactate, glutamine, and glutamate biosensors are amperometric electrodes that have immobilized enzymes in their membranes. They develop a current proportional to the substrate being measured.

Photometry (Phosphate and Glycerol)
The photometry method measures the change in light transmission through a sample mixture to calculate the analyte concentration in the sample.

The phosphate assay is based on the reaction of phosphate ions with ammonium molybdate to form an ammonium phosphomolybdate complex which is converted to a blue color using a reducing agent.

The glycerol assay is based on oxidation of glycerol into formaldehyde using sodium meta-periodate in buffered solution.

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Unlike in-situ monitoring devices, BioProfile Analyzer's automated calibration protocol provides precise quality control and maintains consistency of test results. Further, BioProfile's automated measurement provides faster, more accurate results than off-line methods.

Results obtained from the BioProfile Analyzer show excellent correlation with conventional techniques.

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FULLY-AUTOMATED TESTING
BioProfile Analyzers are fully automated and designed for easy use by any operator. After the "ANALYZE" key is pressed, the sample is automatically aspirated, and the analysis is performed without further operator intervention. An on-board computer monitors the analysis cycle from sample aspiration to results presentation. The operational status of the BioProfile Analyzer is continuously displayed; any deviation from normal operation is promptly reported to the operator with any suspect data flagged.

PRESENTATION OF TEST RESULTS
BioProfile Analyzers report test results on a CRT or monochrome display and a built-in printer. The analyzer can be programmed to alert the operator automatically when test data are outside pre-determined normal ranges and critical limits. Out-of-range test samples are flagged on all data print-outs.

All results can be stored for review individually or for trend analysis, using the optional BioProfile Data Management System (BDM), or via an external computer with appropriate data communications software.

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AUTOMATED BATCH PROCESSING
BioProfile Basic, 100 Plus, 300 and 400 offer a 40-position sample tray that enables batch processing with full walkaway automation. The sample tray will accommodate a variety of tube sizes including:

• 500 µL - 2 mL Eppendorf tubes
• 500 µL - 4 mL sample cups
• 5 mL - 7 mL test tubes

A complete 40-sample tray can be analyzed in approximately 80 minutes.

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Mobile workstation carts with UPS power supplies are available for all BioProfile models. These carts allow transport of the analyzer to any location.

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Nova's OPC Server software allows the BioProfile Analyzer to transfer analytical data on key chemistries to any bioreactor controlling software that is OPC compliant. This critical data allows the controller to initiate real time feedback control to optimize the bioprocess. The OPC Server software can be installed on the Nova Biomedical Data Manager (BDM) or on an ancillary computer.

An acronym for "OLE for Process Control," OPC is a published industrial standard for system interconnectivity that provides a standards-based infrastructure for the exchange of process control data. It uses Microsoft COM and DCOM technology to enable applications to exchange data on one or more computers using client server architecture.

OPC defines a common set of interfaces so that each application retrieves data in exactly the same format, regardless of the data source. Using OPC standards, data can be transmitted from any data source to any OPC-compliant application including HMI/SCADA, data historians, spreadsheets, and databases. The result is a complete, out-of-the-box, plug and play communication solution.

True interoperability reduces implementation costs and builds a fully scaleable system to accommodate your current and future bioprocessing requirements.

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21 CFR Part 11 describes regulatory requirements governing electronic signatures and records that assure the integrity of data within a diagnostic instrument such as the BioProfile Analyzer.

The BioProfile Data Management System (BDM) incorporates an effective archival and restorative mechanism as well as adequate security features and audit trails to automatically monitor the creation, modification, and deletion of electronic records. These features create full compliance with 21 CFR Part 11 requirements.

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The BioProfile Instrumentation Qualification (IQ) protocol provides comprehensive information to assist you in validating your BioProfile Analyzer for use in your bioprocess.

The IQ protocol includes:

• System documentation
• Pre-installation checks
• Installation procedure checks
• Installation performance qualification
• Instrument/system control verification

The BioProfile Instrumentation Qualification/Operation Qualification (IQ/OQ) service includes all Installation Qualification procedures outlined above, plus:

• Performance of IQ/OQ procedures
• All required NIST traceable standard materials
• Statistical analysis and final report

These optional services can be performed either during installation or at a later date.

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