Advance The Potential Of Your Cell Culture Cedex Bio And Cedex Bio HT .

Advance the potential of your cell cultureCedex Bio and Cedex Bio HT Analyzers

The value of certaintyCedex Bio and Cedex Bio HT AnalyzersUnderstanding the challenges of bioprocess monitoringWhether you are working in the pharmaceutical or biotech industry, you always value the safety andconfidence of monitoring and analyzing cell culture with state of the art solutions.As one of the leaders in the diagnostics and pharmaceutical field, Roche has first-hand experience withchallenges in biomanufacturing. That knowledge, plus many years of competence in designing diagnostictests and engineering analyzer systems, are the foundation for the Cedex Bio Analyzer family from RocheCustomBiotech.The Cedex metabolite analyzers are based on enzymatic assays, enabling high robustness and sensitivityas well as optimized measurement ranges, adapted to the particular demands of cell culture and fermentationprocesses. Thus, you can rely on one instrument family to capture useful and timely insights into yourbioprocess and make the right decisions for optimal manufacturing outcomes.We continuously improve the performance and level of integration of our analyzers to support you with reliableand up-to-date instruments. Moreover we are offering a comprehensive test menu we are constantly evolvingaccording to the user needs, so you can flexibly monitor multiple and modern parameters in your bioprocesswithout having to develop new assays on your own or purchase additional instruments.Act on predictability and accuracy2 Advance the potential of your cell culture140130120Recovery [%]Ultimately, having a bioprocess under controlmeans pre-dicting changes in cell cultivation andfermentation that can impact product yield andquality. This is especially true when running thebioprocess within narrow specifications, such asunder substrate-limiting conditions. High predicta bility requires precise and accurate data that reflectthe actual conditions in a bioreactor, even at lowanalyte concentrations. Compared to membranebased analyzers, the Cedex Bio Analyzers offersignificantly higher reproducibility, accuracy andprecision (Figure 1). For example, you can rely onthe monitoring results to indicate the right timepoints for substrate bolus shots or harvest.Precision in metabolite testing - comparisonwith membrane technology in glucose analysis11010090807060Membrane analyzerCedex Bio HT Analyzer504001000200030004000500060007000Target concentration [mg/L]Figure 1: Recovery of glucose concentration was determinedin parallel using the Cedex Bio HT Analyzer and a membraneanalyzer (Roche evaluation data).

Information about the conditions in a cell culture mustbe available in time to enable controlled processingwith optimal manufacturing outcome. Thus, the CedexBio Analyzers offer an assortment of assays, somedesigned specifically to determine the product yieldand quality throughout the fermentation process.Quantify IgG levels in minutes and with the sameaccuracy as the gold standard HPLC (Figure 2).In addition, determine lactate dehydrogenase (LDH)as a sensitive control for cell integrity. A rising LDHactivity in the culture medium is an early indicatorof cell lysis, which is combined with the releaseof intracellular proteases, glucosidases and otherdegrading proteins, generating a considerable riskfor the yield and quality of the valuable product.IgG concentration [arbitrary units]See relevant information in timeIgG: Cedex Bio HT vs HPLC8Cedex Bio HT in Bldg. ACedex Bio HT in Bldg. BHPLC (Protein A)76543variation coeff. 6%versus HPLC210123456789 10 11 12 13 14 15 16 17 18sample #Figure 2: Results comparable to HPLC. The IgG titer inthe culture medium was monitored over a production periodof 18 days. Samples were analyzed in parallel using HPLC(Protein A) and two Cedex Bio HT Analyzers in separatelocations (bldg. A/B). The consistent results representthe perfect precision and the equivalence of the methods(Roche evaluation data).Count on answers, every timeCedex Bio Analyzers were developed based on industry-proven diagnostic technology. Adapted to supportprocess development and large-scale production at Roche Pharmaceuticals, each instrument withstandsthe demanding conditions in the daily bioprocessing, with need for high robustness and minimal manualinteraction.The flexible capabilities for automated sample pre-dilution, the long on-board stabilitiesof the reagents and the long calibration intervals, the dedicated multi-analyte calibratorsand controls, and the identification of reagents and samples via barcodes, make Cedex BioAnalyzers a perfect match for highly efficient process monitoring.Advance the potential of your cell culture 3

Powerful, flexible and comprehensive cell culture profilingCedex Bio and Cedex Bio HT AssaysFind answers you need, with a comprehensive test panelEach available assay facilitates tight control of biopharmaceutical manufacturing, and new assaysare consecutively added to the menu based on industry knowledge and requests from customers.Thus, with a single platform, you have continuously increasing testing flexibility and insights tooptimize your bioprocess.Culture control formammalian cells, bacteria, yeast & insect cellsSubstrates Ala-Gln eMetabolites AcetateAmmoniaFormateLactateLDHOsmolality atePotassiumPyruvateSodiumSucroseAdditional assays are in development.Visit custombiotech.roche.com/cedex for updates or contact your local CustomBiotech team.4 Advance the potential of your cell cultureProducts Ig Fab (human)IgG (human)Mouse lgGOptical Density (bio mass)Total Protein

Select the right analyzer to optimize your bioprocess workflowDifferent specifications, identical test resultsCedex Bio AnalyzerCedex Bio HT AnalyzerThroughput50  – 100 tests per hour200 – 400 tests per hourSample capacityup to 8 samples at once (continuous loading)up to 96 30 samples at once (continuous loading)Test kit capacity1332Daily maintenance"semi-automated", 5 min minutes hands onautomatedAutomated on-board sample dilutionselectable dilutionfreely programmableCedex Bio and Cedex Bio HT Analyzersdeliver consistent results9000Glucose [mg/L]Although the two analyzers differ in throughput andcertain aspects you can rely on equivalent results.High correlation between the Cedex Bio and theCedex Bio HT Analyzer has been proven for all assays.Cedex Bio HT Analyzer800070006000500040003000y 1.002xR 2 0.998200010001000 2000 3000 4000 5000 6000 7000 8000 9000Cedex Bio AnalyzerFigure 3: Comparison of the Cedex Bio and Cedex Bio HT Analyzershowing the same recovery of glucose (Roche evaluation data).Advance the potential of your cell culture 5

Cedex Bio AnalyzerSmall footprint, big impact48 cm, 18.9 in55 cm, 21.7 in60 cm, 23.6 inweight 33.0 kgA reliable, high-quality instrument for small sample throughput Small size: Benchtop system suitable for any spaceEasy handling: Sophisticated and intuitive operating softwareIntegrated processing unit: Built-in touchscreen reduces qualification effortReliable answers: Robust and proven technologyEfficiency: Low maintenance effort and frequency save time and moneyCedex Bio and Bio HT Analyzer Same menu of enzymatic assays with high specificity and sensitivity LIMS connectivity through middleware systems with complete traceability and regulatory compliance6 Advance the potential of your cell culture

Cedex Bio HT AnalyzerHigh efficiency, fast actionThe right instrument for improved workflow efficiency High throughput: Numerous samples can be processed simultaneously with minimal manual interventionEnhanced flexibility with the 96-well Upgrade Kit: Use 96-well plates or conventional racks (total capacity: up to 96 30 samples) Boosts processing safety and efficiency, minimizing overall hands-on time (e.g., 96 glucose assays in 35 min) Designed for manual or robotic loading of 96-well platesLong-term operation: Long time on-board stability of reagents and assay calFlexible dilution: Automated sample dilution capabilities save time and accuracyFull automation: Online integration with automated systems to optimize measurement points and timelinesIntegration system*FeedingFeedbackAutomated sterile samplingSm@rtlineData Cockpit**Analytical resultsSample distributionto analyticsCedex HiRes AnalyzerCedex Bio HT AnalyzerFigure 4: Process integration and automation capabilities with Cedex Bio HT and Cedex HiRes Analyzer*Various integration systems are available. **Sm@rtline Data Cockpit is provided by AGU, Leverkusen, GermanyAdvance the potential of your cell culture 7

Ordering informationProductCatalog numberCedex Bio Analyzer06 395 554 001Cedex Bio HT Analyzer06 608 116 001Kit 96-well plate Cedex09 181 687 001Rack 96-well plate Cedex09 241 400 001The ordering information for all Cedex Bio Analyzer and Cedex Bio HT Analyzerassays is available on custombiotech.roche.comRegulatory disclaimerFor use in quality control/manufacturing process only.TrademarksCEDEX is a trademark of Roche.custombiotech.roche.com/cedexPlease contact your local CustomBiotech representativeEurope, Middle East, Africa, Latin AmericaPhone 49 621 759 8580Fax 49 621 759 6385mannheim.custombiotech@roche.comJapanPhone 81 3 6634 1046Fax 81 3 5479 0585japan.custombiotech@roche.comUnited StatesPhone 1 800 428 5433 (toll-free)Fax 1 317 521 4065custombiotech.ussales@roche.comAsia PacificPhone 65 6371 6638Fax 65 6371 6601apac.custombiotech@roche.comCanadaPhone 1 450 686 7050Fax 1 450 686 7012custombiotech.can@roche.comPublished byRoche Diagnostics GmbHSandhofer Straße 11668305 MannheimGermany 2022 Roche Diagnostics GmbHAll rights reserved.

6 Advance the potential of your cell culture 55 cm, 21.7 in 48 cm, 18.9 in 60 cm, 23.6 in weight 33.0 kg Cedex Bio Analyzer Small footprint, big impact Cedex Bio and Bio HT Analyzer Same menu of enzymatic assays with high specificity and sensitivity LIMS connectivity through middleware systems with complete traceability and regulatory compliance A reliable, high-quality instrument .