The BioProfile® FLEX2 integrates Nova’s innovative MicroSensor™ Card technology with freezing point osmometry and optical measurement for a comprehensive and automated cell culture analyzer that eliminates maintenance of chemistry sensors, reduces sample volume and increases the speed of analysis.
The entire 16 cell culture test menu comprises Gluc, Glu, Lac, Gln, NH4+, K+, Na+, Ca++, pH, PO2, PCO2, viable cell density, total cell density, viability, cell diameter and osmolality.
In contrast to the earlier generation BioProfile FLEX, no maintenance is required for any of the 11 gas and chemistry sensors. Sample volume for the entire test menu is also decreased by 75% to 275 µL, and testing time is decreased to just 4.5 minutes.
Automated sampling from syringes, 96-well plates or a 24-position external “load-and-go” sample tray offers the highest workflow efficiency and flexibility for cell culture monitoring.
Video Credit: Nova Biomedical
Fully automated sampling options
FLEX2 online autosampler
The BioProfile FLEX2 is capable of automated online sampling. The FLEX2 On-Line Autosampler (OLS) from Nova offers a completely automated sampling from almost all culture systems, right from single-use bench-scale bioreactors to large production bioreactors.
When linked to an OPC-compatible control system, the FLEX2 with OLS offers live data transmission for automated sampling, analysis and feedback control of all measured parameters. In addition, the OLS can link up to 10 vessels and users can complete the setup time for a full bench of 10-bioreactors within just 20 minutes.
Image Credit: Nova Biomedical
FLEX2 and ESM integration with ambr® 250 and ambr® 15 cell culture systems
Nova has also integrated the FLEX2 analyzer with ambr 15 and 250 microbioreactors to offer a completely automated system.
The optional External Sampling Module (ESM) of the FLEX2 automatically delivers cell culture specimens from ambr 15 and ambr 250 microbioreactor systems to the FLEX2 device for analysis.
Video Credit: Nova Biomedical
Maintenance-free microsensor cards
Gas and chemistry biosensors are integrated into credit-card-sized MicroSensor cards, which use the established Nova biosensor technology that has been verified in scores of cell culture processes. The MicroSensor Cards are maintenance-free and can be replaced in seconds.
Image Credit: Nova Biomedical
Cartridge-based reagent management system (RMS)
FLEX2’s RMS includes smart reagent cartridges that are user-friendly with simple snap-in replacement.
- RMS automatically records the lot number, expiration and installation date and time of cartridges.
- Within the cartridge, a self-contained waste receptacle prevents direct handling of waste and also prevents direct contact with dangerous trypan blue and biological materials. Other kinds of systems can pose considerable waste handling hazards to operators.
- RMS tracks reagent usage and offers live reagent status and alerts, thus increasing the readiness of the analyzer.
Fast analysis time
Complete test results, such as pH/gases, cell density/viability and critical chemistries, are available in just 4.5 minutes. Throughput for individual modules is only 2.0 minutes.
Small sample volume
A full 16-test profile requires a sample volume of 275 μL, allowing extensive testing even from low-volume culture systems. Separate modules need as little as 135 μL.
Analysis time and sample size when modules are run individually
Table 1. Source: Nova Biomedical
| Module |
Analysis Time |
Sample Size |
Gas Module:
pH, PCO2 , PO2 |
120 sec |
275 μl |
Chemistry Module:
Gluc, Lac, Gln, Glu, NH4+, Na+, K+, Ca++ |
120 sec |
135 μl |
Osmometry Module:
Osmolality |
240 sec |
145 μl |
Cell Density/Viability Module:
Total cell density, viability, cell diameter |
240 sec |
135 μl |
Analysis time and sample size when all modules are run collectively
Table 2. Source: Nova Biomedical
| Module |
Analysis Time |
Sample Size |
| All Modules-All Tests |
270 sec |
275 μl |
Walkaway automation
The high-capacity, 48-position osmometer of the FLEX2 allows walkaway, automated sampling of up to 48 specimens without any intervention of users. This considerably extends maintenance intervals.
Moreover, the high-capacity tray allows fully automated sampling for all tests, including osmometry, for automated culture systems such as the Sartorius ambr 15.
This prevents the need to substitute osmometer tubes in the middle of a sampling set and enables sample scheduling in the middle of the night, during holidays and weekends, without having to do any maintenance during the entire batch of automated samples.
This ability frees up the system to carry out regular sampling of non-automated cultures during normal business hours.
Image Credit: Nova Biomedical
Maximum workflow efficiency
Rapid analysis time, a choice of three sampling modes, easy touch screen operation and automated quality control (QC) offer labor savings, maximum simplicity and workflow efficiency for monitoring cell cultures.
Onboard automated QC
True verification of FLEX2 performance is offered by onboard liquid QC, saving hours of labor every week when compared to manual QC testing. Controls are run automatically at user-defined intervals, QC cartridges include a 30-day supply of QC material, and QC data is logged automatically and filed in a variety of formats.
24-position, external load-and-go tray
An external load-and-go sample tray enables constant loading of cell culture samples for the most efficient and flexible sample throughput.
Image Credit: Nova Biomedical
Automated, 96-well plate analysis
The FLEX2 is the world’s only cell culture analyzer to provide automated sampling from 96-well plates.
Image Credit: Nova Biomedical
Syringe or cup sampling
Separate samples can also be examined directly from cups or syringes. Batch sampling performed through the 96-well plate and/or external “load-and-go” sample tray runs can be interrupted at any time to run crucial gas syringe samples.
Image Credit: Nova Biomedical
Advanced OPC connectivity
The OPC connectivity from Nova combines the FLEX2 with any OPC-compliant devices, like data historians, bioreactor controllers, plant management systems and laboratory information management systems (LIMS).
Listed below are Nova’s OPC connectivity features:
- Data archiving
- Automated bidirectional data as well as control commands
- Connectivity verification
- Can be linked to any OPC-compliant device
- Remote monitoring of data and status
- Bioreactor feedback control
GMP compliance
The FLEX2 complies with GMP manufacturing requirements via operational qualification (OQ) and installation qualification (IQ) documentation and validation support from Nova experts.
Compliance with 21 CFR Part 11
Limited access
User password and ID protect user log-on. Automatic log-off features inhibit unauthorized access.
Electronic record retention and retrieval
- Records can be readily retrieved throughout their retention period
- All data is safely retained via password access control in both electronic and human-readable forms
Audit trails
- Time-stamped audit trails capture the time and date of operator entries and actions that generate, delete or alter electronic records
- Records are preserved in the original and audited form
- Record changes do not obscure the formerly recorded data