1. The CuBiAn XC – A universal tool for your bioprocess analysis
Photometric, automated,
XC: Extra Compact
photometrisch, automatisiert,
Gelöste Substanzen: Substrate, Metabolite, Aminosäuren, Protein
CellD
20bis, rue du Chapitre
F ROQUEMAURE
Tel : +33 (0)
Fax : +33 (0)
Alexander Hähnel
Sandra Koptik

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

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

4. Sample & Reagent Handling
Simple, automated handling or reagents and samples
Sample & Reagent Handling
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

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

6. Accuracy and precision
Liquid handling
Accuracy and precision
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)

7. Accuracy and precision
Calibrator and Control liquids
Accuracy and precision
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

8. Accuracy and precision
Calibration graphs
Accuracy and precision

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

10. Accuracy and precision
Customizable warning scenarios
Accuracy and precision

11. The assay portfolio Extract of current assays and ranges
(hs) IgG – 500 mg/L
(hc) IgG 2.8 – g/ L
Total Protein – 2.25 g / L
Glucose g/L
Lactate – 8.0 g/L
Ammonium – 9.0 mM
Glutamine – 10 mM
Glutamate – 10 mM
Inorganic Phosphor 0.13 – mM
LDH (L->P; P->L) 13 – 2800 U/L
Na mM
K mM
CL mM
Reagents
ISE unit
Reruns and pre-dilutions allow to enlarge the measurement ranges displayed above

12. Recently launched, in final tests, under development
The assay portfolio
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)

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

14. The IgG assay principle
Principle of immuno turbidimetry
The IgG assay principle

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

16. The IgG assay principle
Comparison measurements against HPLC
The IgG assay principle
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17. The Validation Package
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

18. Photometric vs. Membrane based analysers
Comparison to membrane based analysers
Photometric vs. Membrane based analysers
Membrane based (electrochemical) systems
CuBiAn® photometric & immuno-turbidimetric systems
Expandability
Limited
Nearly unlimited and customizable
Necessary Frequency of Calibration
Very high
Once per lot of reagents
Reproducibility of Results
Low
High
Immuno-turbidimetry
Not possible
Implemented
On-line capability
Limited due to chemical sterilization
BayChromat® CellCount + CuBiAn®XC with steam sterilized sample valve
Rate analysis

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

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

21. Automation capability
The automation capability of the CuBiAn XC
Automation capability
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

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

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