Cedex Bio HT Bioprocess Analyzer. Be Confident. Be Assured.

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1 Cedex Bio HT Bioprocess Analyzer Be Confident. Be Assured.

2 Next Generation Technology for Bioprocess Analytics Analyze Your Samples with Confidence. Be Assured of the Data Integrity. Metabolite Screening Substrate Analysis Fermentation Analysis At-Line Monitoring Quality Reliable photometric technology based on 40 years of experience High accuracy and precision for entire assay range Broad dynamic range and sensitivity Performance superior to membrane technology 5% variability between instruments and reagent lots Speed Automated daily maintenance Pre- and post-dilution capabilities Long reagent on-board stability Reagent loading capacity of 32 cassettes 90 samples loaded at one time Average maintenance is just about 100 minutes per year Value Versatile menu tailored to today s workload Expandable menu for tomorrow s requirements One instrument for multiple parameters of mammalian, bacterial, and yeast culture systems Minimal hands-on time: a true walk-away analyzer Consistent results using the Cedex Bio and Cedex Bio HT Bioprocess Analyzers CEDEX and ISE are trademarks of Roche. For use in quality control/manufacturing processes only.

3 Performance Characteristics Process Control with Maximal Reliability. Comparison of Cedex Bio HT and Membrane Technology in Glucose Analysis Cedex Bio HT instrument data demonstrate greater accuracy and precision (1, 2), sensitivity (3) and linearity (4) compared to instruments using membrane-based amperometric technology. Measuring Ranges of the Tests Analyte Test range With automatic dilution up to Acetate Ammonia (NH3) mmol/l mg/l mmol/l mg/l 2.54 mol/l 150 g/l 1.39 mol/l 23.6 g/l Recovery [%] (3) (4) (1,2) Calcium Cholesterol Galactose Glucose mmol/l mg/l mmol/l mg/l mmol/l g/l mmol/l mg/l 500 mmol/l 20 g/l 207 mmol/l 80 g/l 3.9 mmol/l 700 g/l 4.16 mol/l 750 g/l Target Concentration [mg/l] Membrane analyzer Cedex Bio HT Figure 1: Recovery of glucose concentration was determined in parallel using the Cedex Bio HT System and a membrane analyzer. Recovery is calculated as percentage of the measured value to the respective target value of a standard solution. A total of 250 measurements of standards with different concentrations was made over a six month period. Glutamate Glutamine Glycerol IgG Iron Lactate mmol/l mg/l mmol/l mg/l mmol/l mg/l µmol/l mg/l μmol/l mg/l mmol/l mg/l 1 mol/l 150 g/l 1 mol/l 150 g/l 1 mol/l 92.1 g/l 1.07 mmol/l 160 g/l 17.9 mmol/l 1 g/l 1.55 mol/l 140 g/l High Correlation for the Cedex Bio and Cedex Bio HT Analyzer Cedex Bio HT glucose [mg/l] y = 1.002x 3000 R 2 = Cedex Bio Figure 2: The Cedex Bio and Cedex Bio HT Systems show the same recovery of glucose. LDH U/L 100 ku/l Magnesium Phosphate Potassium (ISE) Pyruvate Sodium (ISE) mmol/l mg/l mmol/l mg/l mmol/l g/l mmol/l mg/l mmol/l g/l 250 mmol/l 6.08 g/l 836 mmol/l 79.5 g/l 800 mmol/l 69.6 g/l Total Protein g/l max. solubility

4 System Specifications High-level System Robustness. Test Throughput (Theoretical Max) Sample Types Sample Handling Up to 320 tests/hour (including ISE) mammalian cell culture; microbial fermentation Up to 90 sample tubes in 6 racks on-board, samples can be replaced during operation Cooled rack position for controls and calibrators Automated sample dilution Barcode reading via laser scanner, with immediate STAT recognition Sample Container Types Sample Volume Sampling tubes: 5 10 ml; ; 16 75; ; mm Standard cup: 1.5 ml Micro Micro cup: 650 μl Cup on tube definable Minimal sample volume of 100 µl for several tests, 2 20 µl sample consumption per test Sample Barcode types Code 128, Codabar, Code 2 of 5 interleaved, code 39 Reagents Onboard Capacity Reaction Cells Control Unit System Interfaces Electrical Requirements Physical Dimensions Weight Water Requirements Certification Up to 32 Cedex Bio HT reagent cassettes in 8 racks on-board, tests per cassette, Cooled reagent compartment (10 15 C), on-board stability up to 3 months, Calibration typically once per lot Holds 1000 disposable cuvettes with 5 mm path length and μl reaction volume HP workstation running Windows XP, Intel Pentium IV with 512 MB RAM, Dual 40 GB hard drives, CD Rom, floppy drive and built-in modem RS 2332 serial interface, bidirectional, built-in modem for remote access / volts AC, 50 or 60 Hz, consumption 1200 VA Width: 135 cm (53.1 in.) Depth: 66 cm (25.9 in.) Height: 75 cm (28.5 in.) 320 kg (506 Ibs) Up to 2 liters per hour in operation mode, Type 1 NCCLS CE, UL, C-UL For use in quality control/manufacturing processes only.

5 System Overview and Capabilities Minimal Hands-on Time: A True Walk-away Analyzer Low maintenance Automated daily maintenance reduces operator intervention Robustness assures minimal downtime Result security Precision Technology Precise temperature controlled rotor ensures reliability Sensitive photometric and turbidmetric measurements Highly sensitive pressure sensors detect incorrect pipetting, even at 2 µl volume Sample probe debris removed upon detection ISE module Rapid measurement of sodium and potassium Flexible change of onboard tests Refrigerated storage for long on-board and calibration curve stability Easy reagent cassette changes while system operates Continuous sample loading Up to 90 samples on-board supported by continuous reloading Automated pre- and post-dilution options

6 Published by Roche Diagnostics GmbH Sandhofer Straße Mannheim Germany 2015 Roche Diagnostics. All rights reserved. cedexbio.roche.com Your Roche Custom Biotech Contacts Europe, Middle East, Africa, and Latin America Roche Diagnostics Deutschland GmbH Sandhofer Straße Mannheim, Germany Phone Fax United States Roche Diagnostics Corporation Roche Custom Biotech 9115 Hague Road P.O. Box Indianapolis, IN , USA Phone , ext (toll-free) Fax Canada Roche Diagnostics 201, Boulevard Armand-Frappier HV 4A2 Laval, Québec, Canada Phone Fax Japan Roche Diagnostics K.K. Roche Custom Biotech 6-1, Shiba 2-chome Minato-ku, Tokyo , Japan Phone Fax Asia Pacific Roche Diagnostics Asia Pacific Pte. Ltd. Regional Business Development 8 Kallang Avenue # 10-01/09 Aperia Tower 1 Singapore, Phone Fax custombiotech.roche.com

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