One Automated Analyzer for Fast Comprehensive Cell Culture Analysis

BioProfile is a chemistry/cell viability modular instrument that measures up to 16 key cell culture attributes. By combining as many as five separate instruments into one easy-to-use instrument, BioProfile FLEX simplifies workflow and saves time, labor, and operating cost versus multiple instruments. Applications of BioProfile FLEX include:

• Monitoring the progress of bioreactor runs
• Determining 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.

Modular, Field Upgradeable System

The modular design of BioProfile FLEX can be customized with one to four analytical modules, to consolidate up to 15 vital cell culture tests.

One Fast, 2-8 Minute Analysis

Saves as much as 30 minutes per sample compared to using multiple instruments.

One Integrated Data Report

Simplifies data collection, analysis, archiving, and regulatory compliance.

One Intuitive User Interface

Saves 30 or more operator steps compared to multiple instrument interfaces

One Small, 1 mL Sample

Conserves cell culture mass and end product.

One Consolidated Workstation

Saves up to 15-20 square feet of valuable bench space and saves hours of maintenance each month compared to multiple instruments.

Optional Equipment

On-Line Autosampler

An automated sampling system connects up to 10 bioreactors to one BioProfile FLEX.

• Maintains a sterile barrier
• Provides real time testing either automatically pre-scheduled or manually initiated

Advanced Connectivity

Provides automated bi-directional flow of data and control commands

The BioProfile Connectivity Suite uses OPC (OLE for Process Control), for bi-directional communication with other devices. OPC is an industry-wide standard for open connectivity of devices. The BioProfile Connectivity Suite integrates BioProfile FLEX with other OPC compliant devices such as bioreactor controllers, data historians, laboratory information management systems, and plant management systems.

• Easy, plug-and-play connection to OPC compliant devices
• Bi-directional acknowledgement of connectivity transactions
• Remote monitoring of BioProfile FLEX status and data.

Specifications

Sample Analysis Time:
2.5 minutes (Gases only - PO2 + PCO2)
4.0 minutes (Chemistry/Gas & Osmolality)
6.25 minutes (All 16 tests)

Operating Temperature Range:
15-30°C (59-86°F)

Operating Relative Humidity Range:
20-85%

Sample Size:
1 mL (for all modules)

Sampling Options:
Individual via syringe/cup
Automated batch using 20-position sampling tray
On-line, automated from up to ten bioreactors

Electrical Requirements:
90-264 VAC, 50 to 60 Hz (Universal Power Supply)

System Size:
Height: 20 in (50 cm)
Width: 26 in (66 cm)
Depth: 20 in (50 cm)

System Weight:
Analyzer: 94 lbs (42.6 kg) without reagents
Host Computer Monitor/CPU: 41.5 lbs (18.8 kg)

Safety Certifications:
TUV: IEC 61010-1:2001

Quality Systems Certifications:
TUV: ISO9001:2000 FDA Registered Quality Compliant, PAT Compatible, 21 CFR Part 11 Compliant

Chemistry/Gas Module

Assay	Measurement Range	Resolution	Method
Glucose	0.2–30.0 g/L*	0.01g/L	Biosensor
Lactate	0.2–10.0 g/L*	0.01g/L	Biosensor
Glutamine	0.2–12.0 mmol/L*	0.01 mmol/L	Biosensor
Glutamate	0.2–12.0 mmol/L*	0.01 mmol/L	Biosensor
Ammonium	0.2–25.0 mmol/L	0.01 mmol/L	Direct ISE
pH	5.000–8.000	0.001	Direct ISE
PCO2	3.0–300.0 mmHg	0.1 mmHg	Direct ISE
PO2	3.0–800.0 mmHg	0.1 mmHg	Clarke Electrode
Sodium	40–220 mmol/L	0.1 mmol/L	Direct ISE
Potassium	1.0–100.0 mmol/L	0.01 mmol/L	Direct ISE
Calcium	0.10–10.0 mmol/L	0.01 mmol/L	Direct ISE

Calculated Tests: O2 Saturation; CO2 Saturation; Temp. Corrected pH, PCO2, PO2

*Ranges Reflect User Selectable 1:2 Dilution

Osmolality Module

Assay	Measurement Range	Resolution	Method
Osmolality	0–1500 mOsm/kg	1 mOsm/kg	Freezing Point

Cell Density/Viability Module

Assay	Measurement Range	Resolution	Method
Cell Diameter	4 – 50 μm	N/A	Digital Imaging
Detectable Density	50,000 - 100,000,000 cells/mL**	N/A	Digital Imaging
Viability	0 – 100%	N/A	Digital Imaging

**Ranges Reflect User Selectable 1:2, 1:4, 1:5, 1:10 Dilution

IgG Module

Measurement Range: 0.10–10.00 g/L*

*Ranges Reflect User Selectable 1:2 Dilution