Cedex HiRes High Resolution Cell Analyzer. Be Confident. Be Assured.

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1 Cedex HiRes High Resolution Cell Analyzer Be Confident. Be Assured.

2 High Resolution That Counts The Cedex HiRes Analyzer leads the next generation of cell culture analysis, featuring high-resolution scanner-based imaging that enables deeper insights into even subtle changes in your cell culture. Based on the Trypan Blue Exclusion Method, this optimized successor to the world-class Cedex Analyzer offers additional functionality, precise measurements, and state-of-the-art automation. Process Development In biopharmaceutical process development, it is vital to optimize cell culture conditions in order to maximize product yield and quality. Cell density, viability, aggregation rate, morphology, and the amount of cell debris are among the most important indicators of the state of the cell culture inside the bioreactor. Keeping the starting conditions within the required ranges is an absolute prerequisite for any cellular assay, and enables high reproducibility, precision, and comparability over time. The Cedex HiRes Analyzer enables you to closely monitor and document these parameters for direct comparison of large numbers of samples over time. Production The Cedex HiRes Analyzer represents an industry standard for biopharmaceutical production. It can be used in GMP-validated biopharmaceutical production processes worldwide and meets GMP regulations, (e.g., 21 CFR part 11). We provide IQ/QQ, validation services, and the convenience of automated software to perform System Suitability Tests (SST), ensuring optimal performance. For life science research only. Not for use in diagnostic procedures. CEDEX and INNOVATIS are trademarks of Roche. All other product names and trademarks are the property of their respective owners. 2

3 Technology The Cedex HiRes Analyzer features high-resolution scanner-based imaging using an automated Trypan Blue Exclusion method. In addition to cell concentration, the analyzer measures morphological parameters such as cell diameter and compactness, and provides quantitative information about cell aggregation in cell samples. Designed for pharmaceutical process development and industrial production, the Cedex HiRes Analyzer meets GMP compliance requirements. Cell Analysis with High Resolution Imaging Each pixel of a Cedex HiRes image represents 0.8 μm. The Cedex HiRes Analyzer is able to distinguish objects less than 2 μm apart. Advance your research and production using the Cedex HiRes Analyzer s precise functionality, and take advantage of new and varied opportunities for process analysis. Benefit from fully automated cell and aggregate counting and viability determination. Technology: Moving CCD scanner The technology of the Cedex HiRes Analyzer is based on high-resolution digital image recognition. Cells and objects 1 90 μm in size can be detected. The analyzer uses an automated Trypan Blue staining method for viability determination. Monitor cell concentration, viability, and morphological characteristics. Maximize efficiency with automated staining and mixing. Quickly analyze results using comprehensive software features and a user-friendly graphic user interface. Perform automated online sampling (optional). Rely on high levels of imaging, security, and traceability. Technical Data Detectable cell density range Detectable cell diameter range Detectable object diameter range Required sample volume cells/ml 2 μm 40 μm 1 μm 90 μm 300 μl Number of samples 1 20 Physical Dimensions Height 70 mm Width 405 mm Depth 505 mm Weight 28.9 kg 3

4 Designed for the Biopharmaceutical Industry Whether you are running bioreactors or performing cellular assays, information about density, viability, aggregation rate, and cell morphology is an essential factor for reliable data. Developed in close collaboration with customers and researchers, the Cedex HiRes Analyzer is a precisely engineered solution offering a broad range of features: Integrated Multi Sampler for single samples and multiple runs Cultivation Time Chart Cultivation Time Chart Live operator real-time optimization of image analysis Scheduler for cleaning functions Automatic supervision of flow chamber condition (Prescan) Graphical result evaluation Onboard remote sampling port Secured user and rights management Integrated software function (SST) for analysis of performance checks of the system. Remote Sample Port Remote service for screen sharing and data transfer Automation friendly sample handling Audit trail for 21 CFR part 11 compliance The Cedex HiRes Analyzer is designed for projects in cgmp-regulated environments. Fully automated numerical and graphical representation of results. 4

5 Data Management, Automation, and Process Safety Data Management The Cedex HiRes Analyzer incorporates optimized data management. The latest software contains multiple features to secure data handling and result traceability. All measurement data is stored in a database that can be searched using key parameters as filters. Selected measurements can then be viewed, reprocessed and printed. Measurement data is easily exported in several formats, such as XML or Excel- Dif for use with Microsoft Excel. Cedex 2 software is database driven, ensuring that all measurement information, including corresponding images, are available and accessible at any time. Automation The Cedex HiRes Analyzer allows for remote integration and automated in-process control. Optional Cedex Remote Control Software provides the ability to control the Cedex HiRes Analyzer using on-site automation application software. Measurements can be entered and started via the remote interface. Once the measurement has finished, data is automatically forwarded to a predefined location. To allow for smooth integration into remote cabinets, the Cedex HiRes Analyzer has an additional remote port for use with, pipetting robots and other automation. Process Safety Security, transparency, and reproducibility are important when performing daily measurements. The System Suitability Test (SST) is an important process that can be set up after the instrument qualification phase of a validation process is completed. SST uses experimental results to verify that the instrument is reporting accurate results. Verification can be performed on a regular basis using easily obtained measurements. Roche provides products, such as Cedex Density Reference Standard Beads, Cedex HiRes Control Beads, and the SST software function, allowing the user to design protocols to establish their own requirements for cgmp compliance of the Cedex HiRes Analyzers in keeping with quality assurance and risk assessments implemented for validated processes. SST-Trending Chart 5

6 Consumables and Reagents Calibration Beads Tested and optimized for adjusting the Cedex HiRes Analyzer. Consistent production quality. Certificate of Analysis available. The complete procedure is described in the Cedex HiRes Operator s Guide. Viability Beads Enables quick and reliable checks of the optical hardware. Available in four different viabilities for testing low to high viability ranges: 100%, 80%, 60%, and 30%. Density Reference Standard Beads (DRSB) One-point density calibration for the Cedex HiRes Analyzer. Standardized quality assurance when used in System Suitability Tests (SST). Confirmation of the accuracy and precision of measurements to within +/- 5%. Traceable to the Physikalisch-Technische Bundesanstalt Braunschweig/Berlin certified by the Physikalisch-Technische Bundesanstalt Braunschweig/Berlin. Reagent Kit Ready for immediate install and use no mixing or stirring required. Simple and safe waste disposal provides safer handling of hazardous chemicals. The Cedex HiRes Reagent Kit contains all reagents required for preparation, staining, and analysis of eukaryotic cells with the Cedex HiRes Analyzer. Individual reagents required for the Cedex HiRes System can also be purchased as refill kits (4 60 ml). Control Beads Used for frequent inspection of the Cedex HiRes Analyzer. Consistent production quality. Checks the linearity range using three measurement points to confirm that an analyzer is measuring consistently. 6

7 Ordering Information Ordering Information Product Catalog Number Pack Size Cedex HiRes System, including Cedex HiRes Analyzer, Desktop Computer with Flat Screen, Cedex 2 Software, Operator s Guide, and Quick Start Guide Cedex Calibration Breads ml Density Reference Standard Beads Batch A ml Density Reference Standard Beads Batch B ml Cedex HiRes Control Beads ml 6 Cedex HiRes Control Beads ml 5 Cedex HiRes Control Beads ml Cedex HiRes Reagent Kit, including Ultra Pure Water (900 ml), Trypan Blue Solution, 0.2% (60 ml), Detergent, 3% v/v Mucasol (60 ml), Detergent, 3% v/v Mucasol (60 ml), Cleaning Solution (60 ml), Waste Container Cedex Detergent Solution ,000 ml Cedex Trypan Blue Solution Refill ml Cedex Detergent Solution Refill ml Cedex Cleaning Solution Refill ml Cedex MS 20 Sample Tray sample tray Cedex Sample Cups box (500 cups) For life science research only. Not for use in diagnostic procedures. 7

8 Published by Roche Diagnostics GmbH Sandhofer Straße Mannheim Germany 2013 Roche Diagnostics. All rights reserved Your Roche Custom Biotech Customer Service Europe, Middle East, Africa, and Latin America Roche Diagnostics Deutschland GmbH Sandhofer Straße Mannheim, Germany Phone Fax United States Roche Diagnostics Corporation Roche Applied Science 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 Applied Science 6-1, Shiba 2-chome Minato-ku, Tokyo , Japan Phone Fax Asia Pacific Roche Diagnostics Asia Pacific Pte. Ltd. Regional Sales and Market Development 298 Tiong Bahru Road # 16-01/06 Central Plaza Singapore, Phone Fax custombiotech.roche.com

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