BioProfile^® FLEX2

Automated Cell Culture Analyzer with Maintenance-Free Chemistry Sensors

BioProfile FLEX2 combines Nova’s groundbreaking MicroSensor^™ Card technology with optical measurement and freezing point osmometry for an automated and comprehensive cell culture analyzer that eliminates chemistry sensor maintenance, increases analyzer speed, and reduces sample volume. The full 16 cell culture test menu includes: Gluc, Lac, Gln, Glu, NH₄⁺, Na⁺, K⁺, Ca⁺⁺, pH, PCO₂, PO₂, total cell density, viable cell density, viability, cell diameter, and osmolality.

Compared to the previous generation BioProfile FLEX there is no maintenance for any of the 11 chemistry and gas sensors, sample volume for the full test menu is reduced by 75% to 275 microliters, and testing time is reduced to just 4.5 minutes. Automated sampling from 96-well plates, syringes, or a 24-position external “load-and-go” sample tray provides maximum workflow flexibility and efficiency for cell culture monitoring.

Maintenance-free microsensor cards

Chemistry and gas biosensors are combined in credit-card-sized MicroSensor cards, which use proven Nova biosensor technology that has been validated in thousands of cell culture processes. MicroSensor Cards are maintenance-free, and replaceable in seconds.

Cartridge-based reagent management system (RMS)

FLEX2’s RMS features smart reagent cartridges that are easy to use with simple snap-in replacement.
• RMS automatically captures cartridge installation date and time, lot number, and expiration.
• RMS monitors reagent usage and provides real-time reagent status and alerts, maximizing analyzer readiness.
• A self-contained waste receptacle within the cartridge eliminates direct handling of waste and direct contact with hazardous trypan blue and biological materials. Other systems can pose significant waste handling hazards to operators.

Fast analysis time

Comprehensive test results including cell density/viability, pH/gases, and key chemistries are available in 4.5 minutes. Throughput for individual modules is 2.0 minutes.

Small sample volume

Sample volume is 275 μL for a full 16-test profile, enabling comprehensive testing even from low volume culture systems. Individual modules require as little as 135 μL.

Analysis time and sample size when modules are run individually

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

All Modules-All Tests

270 sec

275 μl

Maximum Workflow Efficiency

Simple touchscreen operation, a choice of three sampling modes, fast analysis time, and automated quality control (QC) provide maximum simplicity, labor savings, and workflow efficiency for cell culture monitoring.

Onboard automated QC

Onboard liquid QC provides true verification of FLEX2 performance and saves hours of labor each week compared to manual QC testing. QC cartridges contain a 30-day supply of QC material. Controls are run automatically at user-selected intervals and QC data is automatically logged and filed in a variety of formats.

Online autosampling from microbioreactor systems including ambr^®15 and ambr^®250

24-position, external load-and-go tray

An external load-and-go sample tray allows for continuous loading of cell culture samples for the most flexible and efficient sample throughput.

Automated, 96-well plate analysis

FLEX2 is the only cell culture analyzer to offer automated sampling from 96-well plates.

Syringe or cup sampling for critical analysis

Individual samples also can be analyzed directly from syringes or cups. Batch sampling via the 96-well plate and/or external “load-and-go” sample tray runs can be interrupted at any time to run critical gas syringe samples.

Advanced OPC Connectivity

Nova’s OPC connectivity integrates FLEX2 with any OPC-compliant devices, such as bioreactor controllers, data historians, laboratory information management systems (LIMS), and plant management systems. Nova’s OPC connectivity features:

• Automated bidirectional data and control commands
• Data archiving
• Connection to any OPC-compliant device
• Connectivity verification
• Bioreactor feedback control
• Remote monitoring of status and data

GMP compliance

FLEX2 meets GMP manufacturing requirements through installation qualification (IQ) and operational qualification (OQ) documentation and validation support from Nova specialists.

Compliance with 21 CFR Part 11

Limited access
User log-on is secured by both user ID and password. Automatic log-off features prevent unauthorized access.

Electronic record retention and retrieval

• All data are securely retained through password access control in both human-readable and electronic forms.
• Records are readily retrievable throughout their retention period.

Audit trails

• Time-stamped audit trails record the date and time of operator entries and actions that create, modify, or delete electronic records.
• Record changes do not obscure previously recorded information.
• Records are maintained in original and audited form.