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www.optocell.de
The CuBiAn XC – A universal tool for your bioprocess analysis
Sandra
Koptik
Alexander Hähnel
CellD20bis, rue du Chapitre F-30150 ROQUEMAURETel : +33 (0)4 66 82 82 60Fax : +33 (0)4 66 90 21 10Email : [email protected] www.celld.com
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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
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Sam
ple
& R
eage
nt H
andl
ing
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
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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 samplesSa
mpl
e &
Rea
gent
Han
dlin
g
4
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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 workflowSa
mpl
e &
Rea
gent
Han
dlin
g
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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 handlingAc
cura
cy a
nd p
reci
sion
6
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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 liquidsAc
cura
cy a
nd p
reci
sion
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Calibration graphsAc
cura
cy a
nd p
reci
sion
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Control status documented in quality graphs
(Levey-Jennings plots)
Accu
racy
and
pre
cisi
on
9
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Customizable warning scenariosAc
cura
cy a
nd p
reci
sion
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(hs) IgG 10.0 – 500 mg/L
(hc) IgG 2.8 – 27.55 g/ L
Total Protein 0.04 – 2.25 g / L
Glucose 0.09 - 6.3 g/L
Lactate 0.05 – 8.0 g/L
Ammonium 0.05 – 9.0 mM
Glutamine 0.06 – 10 mM
Glutamate 0.12 – 10 mM
Inorganic Phosphor 0.13 – 10.32 mM
LDH (L->P; P->L) 13 – 2800 U/L
Na+ 80-180 mM
K+ 1.5 - 10 mM
CL- 60-140 mM
Reruns and pre-dilutions allow to enlargethe measurement ranges displayed above
ISE unit
Reagents
Extract of current assays and rangesTh
e as
say
portf
olio
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Acetic Acid (launched; 0.05 – 1.25 g/L)
Magnesium (launched; 0.2 -3.27 mMol/L)
Cholesterol (launched; 0.87 – 16.6 mMol/L)
Iron (launched; 2 – 198 µMol/L)
Glycerol (final tests; 0.016 -2.5 mMol/L)
Galactose (under development: 0.05 – 7 g/L)
Recently launched, in final tests, under developmentTh
e as
say
portf
olio
12
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Model of a human IgG
Target of the anti-serum in the hs IgG assay
The
IgG
ass
ay p
rinci
ple Principle of immuno turbidimetry
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The
IgG
ass
ay p
rinci
ple Principle of immuno turbidimetry
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The
IgG
ass
ay p
rinci
ple Parameter settings customizable – Instrument Factor
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CuBiAn HT vs. PorosA HPLC
y = 0.8993x - 7.3577
R2 = 0.9988
0
500
1000
1500
2000
2500
0 500 1000 1500 2000 2500[IgG] by PorosA HPLC / (mg/L)
[IgG
] by
CuB
iAn H
T /
(mg/L
)
The
IgG
ass
ay p
rinci
ple Comparison measurements against HPLC
16
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Validation documents are available (Verification documents including IQ, OQ); PQ on demandExperienced validation consulting and support service by OPTOCELL technologyDocuments developed in close cooperation with customers
ValidationTh
e Va
lidati
on P
acka
ge
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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 Not possible Implemented
Phot
omet
ric v
s. M
embr
ane
base
d an
alys
ers
Comparison to membrane based analysers
18
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Membrane based electrochemical (biosensors) systems
CuBiAn® photometric and immunoturbidimetric Systems
Comparison to membrane based analysersPh
otom
etric
vs.
Mem
bran
e ba
sed
anal
yser
s
19
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Comparison to membrane based analysersPh
otom
etric
vs.
Mem
bran
e ba
sed
anal
yser
s
20
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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 TechnologyServices, 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 additionalanalysing devices
Auto
mati
on c
apab
ility The automation capability of the CuBiAn XC
21
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The STAT port
The BayChromat® Cell Count by:Bayer Technology Services,
Leverkusen, Germany
Auto
mati
on c
apab
ility Comparison to membrane based analysers
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Out
look
– C
uBiA
n Fa
mily
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
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