Cedex Bio Bioprocess Analyzer. Be Confident. Be Assured.

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Cedex Bio Bioprocess Analyzer Be Confident. Be Assured.

Next Generation Technology for Bioprocess Analytics Metabolite Screening Substrate Analysis Fermentation Analysis At-Line Monitoring Analyze your samples with confidence. Be assured of the data integrity. Quality Reliable photometric technology Developed utilizing cobas instrument technology and expertise Better accuracy, precision and linearity of data Broad dynamic range and sensitivity Superior performance compared to membrane technology Speed Auto-dilution feature reduces the need for follow up measurements Single module to study up to fourteen analytes Plug and play reagent format Intuitive touch screen driven user interface Seamless data integration capabilities Value Single machine for multiple parameters and culture systems (mammalian, bacterial and yeast) Customizable assay development option Decreased cost due to reduced maintenance Low down time due to robust operation Benchtop instrument with a small footprint Standby 21.12.2009 13:21 Overview 1 2 Workplace 3* 4?? Utilities 5!! 6? 7* 8+ 5 Tests / 2 Blocked 3 Results / 1 Flagged COBAS and CEDEX are trademarks of Roche. For use in quality control/manufacturing processes only. STAT Order Tests Log off Prepare End Shift Perform routine tasks via the overview screen

Comparison of Cedex Bio and Membrane Technology in Glucose Recovery Analysis The data from Cedex Bio demonstrate better accuracy and precision (1,2), sensitivity (3) and linearity (4) compared to membrane based amperometric technology. Parameter Current methods Cedex Bio w/o dilution automatic dilution Recovery [%] 140 130 120 110 (3) (4) 100 90 80 (1,2) Glucose (g/l) 0.2 15* 0.02 7.5 0.02 75 Lactate (g/l) 0.2 5* 0.004 1.4 0.004 14 Ammonia (g/l) 0.0036 0.45* 0.00048 0.012 0.00048 0.48 LDH (U/L) 20 150** 20 1000 20 10000 Glutamine (g/l) 0.030 0.877* 0.06 1.5 0.06 7.5 70 60 50 40 0 1000 2000 3000 4000 5000 6000 7000 Target Concentration [mg/l] Membrane analyzer Cedex Bio Figure 1: Recovery of glucose standard was measured on Cedex Bio and compared to the membrane analyzer. Recovery is estimated as a percentage value using (measured value of the analyte/target concentration) x 100. When the target value is the same as the measured value, the recovery is estimated to be 100%. If the measured value exceeds or is below the target concentration, the values are appropriately measured as greater or less than 100% recovery. A total of 250 data points were measured over a 6 months period. Glutamate (g/l) 0.030 0.882* 0.015 1.5 0.015 7.5 IgG (g/l) 0.035 1.5*** 0.004 0.1 0.1 1.6 0.004 1 0.1 16 Acetate (g/l) 3 1.2 3 12 Ethanol (g/l) 0.1 5 0.1 15 Sodium [g/l] 0.92 5.06* 0.46 5.75 0.46 5.75 Potassium [g/l] 0.0391 0.978* 0.039 1.17 0.039 1.17 * amperometric; ** 96 well photometric method; *** HPLC; Photometric ISE (Ion Sensitive Electrode) Standby 21.07.2009 17:12? Standby 23.07.2009 10:05? Overview Workplace Utilities Order > Identify Sample 7 8 9 4 5 6 1 2 3 0 A-Z Maintenance Deproteinize Probe Electrode Service Clean Housing Call Service Rep. Activate Electrodes Initialize ISE Fluid Sensor Prime Fluid System 23.07. 23.07. 08.01. 09.07. Standby 21.07.2009 13:48? QC History > GLU2 [PNU - 07/06] 06/09 07/09 To begin a test, simply press ORDER and identify the sample Keep track of all service actions through the Maintenance screen Monitor quality control over time with the QC History screen

System Specifications Test Throughput (Theoretical Max) 65 tests/hour for photometry tests only 180 tests/hour for ISE tests only Up to 100 tests/hour for mixed requests Number of Channels (Reagent Slots) 27 slots (or approximately 14 assays) per reagent disk, up to 8 disks 3 channels on ISE module Programmable Parameters Maximum of 50 photometric assays with software v. 3.0 3 ISE tests, 10 profiles Sample Types mammalian cell culture; microbial fermentation Sample Input Load capacity: 8 positions, continuous loading Priority sampling: is available Continuous operation: Additional sample setting during operation Sample cooling: Not available Sample Container Types Sampling tubes: 5 10 ml; 16 x 100; 16 x 75; 13 x 100; 13 x 75 mm Sample cup: 2.5 ml Micro cup: 1.5 ml Cups on tube: Cup on top of a 16 x 75/100 mm tube Sample Volume 2.0 16.5 μl in 0.25 μl steps Sample Dilution 1.5 100 times Minimum Sample Volume Primary tubes: 500 μl Sample cup: 40 μl Micro cup: 40 μl System Interfaces RS 232 serial interface, bi-directional; USB port Sample Data Base 300 test results QC Analysis QC history provides QC results of previous 60 days Graphic analysis of results over time Rerun (automatic dilution) Rerun with predefined dilution factor Electrical Requirements Power requirements: 100 125V and 200 240V (-15% to +10%) 250 VA (320 VA with ISE) Frequency: 50 Hz or 60 Hz ± 0.5% Water/Waste Requirements Minimum: Reagent Grade NCCLS Type II Recommended: Reagent Grade NCCLS Type I Water consumption: 2.5 3.0 L/day Water temperature: 15 32 C Waste: Separate container Operating Conditions Ambient temperature: 15 32 C Ambient humidity: 30 80% (RH, without condensation) Heat output: Maximum 320 W/hr or 270 Kcal/hr Noise output: 60 db Physical Dimensions Width: 28.4 in (720 mm) Depth: 21.7 in (550 mm) Height: 18.9 in (480 mm) Weight 85.1 lbs (38.6 kg) For use in quality control/manufacturing processes only.

Dynamic transfer head Integrated ISE unit Sample loading area Reagent and cuvette rotor Ion Sensitive Electrode (ISE) module User interface Disposable microcuvettes for precise and accurate measurement 12 wavelength photometer for testing beyond routine assays

Published by Roche Diagnostics GmbH Sandhofer Straße 116 68305 Mannheim Germany 2011 Roche Diagnostics. All rights reserved. 06300081990 0211 Your Roche Custom Biotech Customer Service Europe, Middle East, Africa, and Latin America Roche Diagnostics Deutschland GmbH Sandhofer Straße 116 68305 Mannheim, Germany Phone +49 621 759 8580 Fax +49 621 759 8610 mannheim.custombiotech@roche.com United States Roche Diagnostics Corporation Roche Applied Science 9115 Hague Road P.O. Box 50414 Indianapolis, IN 46250-0414, USA Phone +1 800 428 5433, ext. 14649 (toll-free) Fax +1 317 521 4065 custombiotech.ussales@roche.com Canada Roche Diagnostics 201, Boulevard Armand-Frappier HV 4A2 Laval, Québec, Canada Phone +1 450 686 7050 Fax +1 450 686 7012 custombiotech.can@roche.com Japan Roche Diagnostics K.K. Roche Custom Biotech Applied Science 6-1, Shiba 2-chome Minato-ku, Tokyo 105-0014, Japan Phone +81 3 5443 5285 Fax +81 3 5443 7934 japan.custombiotech@roche.com Asia Pacific Roche Diagnostics Asia Pacific Pte. Ltd. Regional Sales and Market Development 298 Tiong Bahru Road # 16-01/06 Central Plaza Singapore, 168730 Phone +65 6371 6638 Fax +65 6371 6601 apac.custombiotech@roche.com custombiotech.roche.com