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Analyzer and accessories
  • Cedex Bio HT Analyzer*, including accessories and disposables
  • Standard laboratory equipment
Calibrators and Controls
  • Calibrator D Bio*
  • Control D Level 1 Bio*
  • Control D Level 2 Bio*
  • Control D Level 3 Bio*
", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "
Test protocol
The standard protocols for determination of galactose or arabinose are GAL2B or ARAB, respectively. If the concentration in samples is expected to be higher than 27 mmol/L, then use protocol GAL2D or ARAD (same protocol with pre-set 1:10 sample predilution).
Cedex Bio HT test definition
Test definitionGAL2B
(091)
ARAB
(110)
GAL2D
(092)
ARAD
(111)
Measuring range
     mmol/L
     mg/L Gal
     mg/L Ara
Standard
0.055 – 27.75
9.9 – 5,000
8.3 – 4,166
High
0.55 – 277.5(1)
99 – 50,000(1)
83 – 41,661(1)
Control levelD 1, 2, 3D 2, 3
Sample predilutionNo1:10
Measuring modeAbsorbanceAbsorbance
Abs. calc. modeEndpointEndpoint
Reaction modeR1-S-SRR1-S-SR
Reaction directionIncreaseIncrease
Wavelength340 nm340 nm
Calc. first/last17/6917/69
Unitmmol/L, mg/Lmmol/L, mg/L
  1. Up to maximal solubility with automatic predilution.
Pipetting parameters
Pipetting parametersGAL2B
(091)
ARAB
(110)
GAL2D
(092)
ARAD
(111)
Water Diluent (Sample Predilution)(1)No20 µL sample + 180 µL water
R1195 μL195 μL
Sample (S)5 μL5 μL
SR40 μL40 μL
Total Volume240 μL240 μL
  1. Sample predilution is performed in a prior step, after which the reaction mix is prepared in the same way as the unmodified sample.
Calibration
Calibration
CalibratorCalibrator D Bio (CAL D, 07-1141-1)
Calibration modeLinear regression
Calibration interval112 days, and if recalibration is required due to QC results.
The lot-specific Instructions for Use of the Calibrator and Control materials show target values for galactose and arabinose. Use the respective value for a protocol for galactose or arabinose testing.
Quality control
Protocols GAL2B, and ARAB
  • Control D Level 1 Bio (COND1, 07-1101-2)
  • Control D Level 2 Bio (COND2, 07-1103-9)
  • Control D Level 3 Bio (COND3, 07-1104-7)
Protocols GAL2D, and ARAD
  • Control D Level 2 Bio (COND2, 07-1103-9)
  • Control D Level 3 Bio (COND3, 07-1104-7)

Use the recommended control material. Other suitable control material can also be used.
Control intervals and acceptance limits should be adapted to each lab\u00adoratory's individual requirements. If values do not fall within the defined limits, corrective measures and recalibration are required.
The lot-specific Instruction for Use of the Calibrator and Control materials show target values for galactose and arabinose. Use the respective value for a protocol for galactose or arabinose testing.
Conversion factors
Conversion factors for galactose concentration:
  • 1 mmol/L = 180.2 mg/L
  • 1 g/L = 5.55 mmol/L
Conversion factors for arabinose concentration:
  • 1 mmol/L = 150.1 mg/L
  • 1 g/L = 6.66 mmol/L
Traceability
This method has been standardized against net weight.
Precision
Representative performance data on Cedex Bio HT Analyzers are shown. Results obtained in individual laboratories may differ. Precision was determined in samples of three concentration levels. Coefficients of variation (CV) were calculated for in-run precision (n=21) and inter-run precision (on 10 days).
GalactoseLevel 1Level 2Level 3
Mean [mmol/L]0.77.021.0
CV in-run [%]0.81.20.7
CV inter-run [%]3.62.83.5
ArabinoseLevel 1Level 2Level 3
Mean [mmol/L]0.77.021.0
CV in-run [%]1.20.50.4
CV inter-run [%]2.01.41.6
", "Name": "Protocols" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "
VialContentComposition
GAL2BReagent cassette,
200 tests
Reagent 1 (R1): β-galactose dehydrogenase, 3 U/mL; preservative; TRIS buffer, pH 8.5.
Start Reagent (SR): Oxidized nicotinamide adenine dinucleotide (NAD+), 15 mg/mL; preservative.
", "Name": "Content" }, { "Language": "en", "Value": "Galactose: In the production of therapeutic proteins using CHO cell cultures, replacement of glucose by galactose can be used to control the glycosylation pattern of the product, especially to maximize the n-glycan galactosylation level. For control of culture media and for monitoring in the culture process, the galactose concentration can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.
Arabinose: Continuous monitoring of the arabinose concentration is required in the process control for E. coli cultures with a pBAD promoter for recombinant protein production. The arabinose concentration needs to be exactly adjusted by appropriate feeding, in order to control the dose-dependent induction of the protein expression and to provide sufficient nutrition to achieve the optimal yield. Using a Cedex Bio or Cedex Bio HT Analyzer, the arabinose concentration can be determined fast and accurately.", "Name": "Applications" }, { "Language": "en", "Value": "Method: Enzymatic photometric assay using galactose dehydrogenase
Recovery: ± 15%", "Name": "Specification" } ] } } ] }

Galactose/Arabinose Bio HT

Cedex Galactose Arabinose

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