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Www.optocell.de The CuBiAn XC – A universal tool for your bioprocess analysis Sandra Koptik Alexander Hähnel CellD 20bis, rue du Chapitre F-30150 ROQUEMAURE.

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Presentation on theme: "Www.optocell.de The CuBiAn XC – A universal tool for your bioprocess analysis Sandra Koptik Alexander Hähnel CellD 20bis, rue du Chapitre F-30150 ROQUEMAURE."— Presentation transcript:

1 The CuBiAn XC – A universal tool for your bioprocess analysis Sandra Koptik Alexander Hähnel CellD 20bis, rue du Chapitre F ROQUEMAURE Tel : +33 (0) Fax : +33 (0)

2 The CuBiAn XC presentation Comparison membrane - photometry The IgG assay principle The assay portfolio Sample & Reagent Handling Accuracy and precision Automation capability of CuBiAn® XC The validation package

3 Sample & Reagent Handling Reagent and Sample Container Unit Photometric Detector Unit Cuvette Platform Reagent and Sample Pipette Unit Incubation Reaction Unit (below cover) Mixing Unit Robotic Cuvette Arm Overview over the analyser 3

4 Most reagents ready-to-use Reagents and samples kept refrigerated on board Reagents and samples optionally identified by barcode reader (type, expiry date, and consumption) Reagents single assays obtainable separately for maximum flexibility Each reagent bottle allows for 96 tests Automatic dilution steps for samples programmable Low sample volume required: 2µL - 35µL per test ≤ 200µL minimum volume The Reagent and Sample Container Unit has space for 20 assay bottles and 10 samples Simple, automated handling or reagents and samples Sample & Reagent Handling 4

5 Samples and reagents automatically pipetted into disposable cuvettes in the Incubation Reaction Unit (IRU) Reactions constantly incubated at 37 °C Rapid delivery of results Each reaction is mixed thoroughly The cuvettes will be uploaded, checked before use and discarded by the automated robot arm Each reaction takes exactly 10 minutes Assays measured every 40 seconds Up to 90 results/hour possible (360 with ISE unit) Samples can be run in replicates (2-40) The measurement workflow Sample & Reagent Handling 5

6 The automated pipetting system for reagents and samples guarantees for a high reproducibility and accuracy The reagent and sample syringes work with a cv of less than 1%, and 2% respectively The accuracy of pipetting can be checked at any time by the user via (SPT+ RPT (Sample and Reagent Precision Tests; part of the CuBiAn ® SST concept) Liquid handling Accuracy and precision 6

7 Two multi- (universal) calibrators create calibration curves for the majority of the assays (Lactate, Glucose, Ammonia, Glutamate, Inorganic Phosphate, Iron, Mg, Cholesterol,...) Separate Calibrators for Glutamine and IgGs Two or three levels of controls (low, medium, high) available to check the system’s precision of the specific assay Calibrator and Control liquids Accuracy and precision 7

8 Calibration graphs Accuracy and precision 8

9 Control status documented in quality graphs (Levey-Jennings plots) Accuracy and precision 9

10 Customizable warning scenarios Accuracy and precision 10

11 (hs) IgG10.0 – 500 mg/L (hc) IgG2.8 – g/ L Total Protein0.04 – 2.25 g / L Glucose g/L Lactate 0.05 – 8.0 g/L Ammonium0.05 – 9.0 mM Glutamine0.06 – 10 mM Glutamate0.12 – 10 mM Inorganic Phosphor0.13 – mM LDH (L->P; P->L)13 – 2800 U/L Na mM K mM CL mM Reruns and pre-dilutions allow to enlarge the measurement ranges displayed above ISE unit Reagents Extract of current assays and ranges The assay portfolio 11

12 Acetic Acid (launched; 0.05 – 1.25 g/L) Magnesium (launched; mMol/L) Cholesterol (launched; 0.87 – 16.6 mMol/L) Iron (launched; 2 – 198 µMol/L) Glycerol (final tests; mMol/L) Galactose (under development: 0.05 – 7 g/L) Recently launched, in final tests, under development The assay portfolio 12

13 Model of a human IgG Target of the anti-serum in the hs IgG assay The IgG assay principle Principle of immuno turbidimetry 13

14 The IgG assay principle Principle of immuno turbidimetry 14

15 The IgG assay principle Parameter settings customizable – Instrument Factor 15

16 10 / 23 The IgG assay principle Comparison measurements against HPLC 16

17 Validation documents are available (Verification documents including IQ, OQ); PQ on demand Experienced validation consulting and support service by OPTOCELL technology Documents developed in close cooperation with customers Validation The Validation Package 17

18 Membrane based (electrochemical) systems CuBiAn ® photometric & immuno-turbidimetric systems ExpandabilityLimitedNearly unlimited and customizable Necessary Frequency of Calibration Very highOnce per lot of reagents Reproducibility of ResultsLowHigh Immuno-turbidimetryNot possibleImplemented On-line capabilityLimited due to chemical sterilization BayChromat ® CellCount + CuBiAn ® XC with steam sterilized sample valve Rate analysisNot possibleImplemented Photometric vs. Membrane based analysers Comparison to membrane based analysers 18

19 Membrane based electrochemical (biosensors) systems CuBiAn ® photometric and immunoturbidimetric Systems Comparison to membrane based analysers Photometric vs. Membrane based analysers 19

20 Comparison to membrane based analysers Photometric vs. Membrane based analysers 20

21 The CuBiAn ® XC can be completely integrated into a fully automated bioreactor environment without any technical hardware changes The remote access software (developed together with Bayer Technology Services, Germany) can be easily upgraded to an CuBiAn ® XC The steam-sterilizable automatic sample drawing system of the BayChromat ® Cell Count has shown its high stability in several contamination-free cultivations, lasting over more than 180 days The BayChromat ® control software allows for the integration of additional analysing devices Automation capability The automation capability of the CuBiAn XC 21

22 The STAT port The BayChromat ® Cell Count by: Bayer Technology Services, Leverkusen, Germany Automation capability Comparison to membrane based analysers 22

23 Outlook – CuBiAn Family Throughput: 270 tests/hour (max. 404 tests/hour with ISE High precision pipettor und reagent pipettor Environment-friendly semi-disposable resin cuvettes Refrigerated Reagent Container Unit Optional built-in ISE module available Optional built-in degaser module available 23


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