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Test Protocol
GAL2B is the standard protocol for galactose determination.
If the galactose concentration of a sample is expected to be higher than 5 g/L (28 mmol/L), then protocol GAL2D should be used (same protocol with preset 1:10 sample predilution).
Results higher than the valid measuring range will be flagged, and a rerun with an automatic 1:10 predilution will be recommended by the software.

Cedex Bio test definition:
Measuring mode               Absorbance
Abs. calculation mode      Endpoint
Reaction direction              Increase
Wavelength                         340 nm
Calc. first/last                      14/40
Unit                                        mmol/L
Reaction mode                   R1-S-SR

Pipetting parameters:
R1                     195 μL
Sample               5 μL
SR             40 μL
Total volume   240 μL

Calibration:
Calibrator                    Calibrator D Bio (CAL D, 794)
Calibration mode       Linear regression
Calibration interval    112 days, and if recalibration is required due to QC results

Quality control:
Controls:
Control D Level 1 Bio (COND1, 307)
Control D Level 2 Bio (COND2, 308)
Control D Level 3 Bio (COND3, 309)
Use the recommended control material. Other suitable control material can be used in addition.
Control intervals and acceptance limits should be adapted to each laboratory's individual requirements.
If values do not fall within the defined limits, corrective measures and recalibration are required.", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "This product is intended for quantitative determination of galactose or arabinose in aqueous solutions using the Cedex Bio Analyzer.", "Name": "Product Description" }, { "Language": "en", "Value": "
Analyzer and accessories
  • Cedex Bio 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": "
VialCapContentComposition
1 GAL2B R1white4 vials,
50 tests each
Reagent 1 (R1): β-galactose dehydrogenase, 3 U/mL; preservative; TRIS buffer, pH 8.5.
2 GAL2B SRblack4 vials,
50 tests each
Start Reagent (SR): Oxidized nicotinamide adenine dinucleotide (NAD+),15 mg/mL; preservative.
", "Name": "Content" }, { "Language": "en", "Value": "Measuring Range
Galactose concentration can be determined in following ranges:
•GAL2B: 0.01 to 5.0 g/L (0.06 to 27.75 mmol/L);
•GAL2D: 0.1 to 50 g/L (0.6 to 277.5 mmol/L),
up to maximal solubility with automatic predilution.

Conversion Factors
Conversion factors for galactose concentration:
1 g/L = 5.55 mmol/L
1 mmol/L = 180.2 mg/L

Traceability
This method has been standardized against galactose net weight.

Precision
Representative performance data on Cedex Bio 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).


  Level 1 Level 2 Level 3
Mean 0.7 mmol/L
(0.126 g/L)
7 mmol/L
(1.26 g/L)
21 mmol/L
(3.78 g/L)
CV in-run 0.9% 0.2% 0.3%
CV inter-run 3.2% 4.0% 3.7%
", "Name": "Background Information - Help Corner" }, { "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

Test kit for the Cedex Bio Analyzer

Cedex Galactose Arabinose

Overview

Ordering

Technical documents

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