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• Cedex Bio HT Analyzer*, including accessories and disposables
• Standard laboratory equipment

• Calibrator D Bio*
• Control D Level 1 Bio*
• Control D Level 2 Bio*
• Control D Level 3 Bio*

", "Language": "en", "Country": "XG", "Code": "Additional Equipment and Reagent Required" }, { "Name": "Protocols", "Value": "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).

Test definition	GAL2B (091)	GAL2D (092)	ARAB (110)	ARAD (111)
Measuring range      mmol/L      mg/L	Standard 0.055 – 27.75 9.9 – 5,000	High 0.55 – 277.5(1) 99 – 50,000(1)	Standard 0.055 – 27.75 8.3 – 4,166	High 0.55 – 277.5(1) 83 – 41,661(1)
Control level	D 1, 2, 3	D 2, 3	D 1, 2, 3	D 2, 3
Sample predilution	No	1:10	No	1:10
Measuring mode	Absorbance	Absorbance	Absorbance	Absorbance
Abs. calc. mode	Endpoint	Endpoint	Endpoint	Endpoint
Reaction mode	R1-S-SR	R1-S-SR	R1-S-SR	R1-S-SR
Reaction direction	Increase	Increase	Increase	Increase
Wavelength A/B	340 nm	340 nm	340 nm	340 nm
Calc. first/last	17/69	17/69	17/69	17/69
Unit	mmol/L, mg/L	mmol/L, mg/L	mmol/L, mg/L	mmol/L, mg/L

1. Up to maximal solubility with automatic predilution.

Pipetting parameters	GAL2B (091)	GAL2D (092)	ARAB (110)	ARAD (111)
Water Diluent (Sample Predilution)(1)	No	20 µL sample + 180 µL water	No	20 µL sample + 180 µL water
R1	195 μL	195 μL	195 μL	195 μL
Sample (S)	5 μL	5 μL	5 μL	5 μL
SR	40 μL	40 μL	40 μL	40 μL
Total Volume	240 μL	240 μL	240 μL	240 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
Calibrator	Calibrator D Bio (CAL D, 07-1141-1)
Calibration mode	Linear regression
Calibration interval	112 days, and if recalibration is required due to QC results.

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.

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).

Galactose	Level 1	Level 2	Level 3
Mean [mmol/L]	0.7	7.0	21.0
CV in-run [%]	0.8	1.2	0.7
CV inter-run [%]	3.6	2.8	3.5

Arabinose	Level 1	Level 2	Level 3
Mean [mmol/L]	0.7	7.0	21.0
CV in-run [%]	1.2	0.5	0.4
CV inter-run [%]	2.0	1.4	1.6

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Vial	Content	Composition
GAL2B	Reagent 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.

", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Applications", "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.", "Language": "en", "Country": "XG", "Code": "Applications" }, { "Name": "Specification", "Value": "Method: Enzymatic photometric assay using galactose dehydrogenase
Recovery: ± 15%", "Language": "en", "Country": "XG", "Code": "Specification" } ] } } ] }