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Cell line and process development: Example results

Head-to-head comparison with ELISA

The diagram below shows the results of a comparative study where Gyrolab was tested against the established ELISA format for process-related impurity testing at MedImmune LLC, Gaithersburg, USA.
Head to head comparison
* 2 analysts for 3 days, 1 analyst for 5 days

Gyrolab

ELISA

Reagents consumption
14 – 20.4 µl
100 – 275 µl
Dynamic range of the standard curve
4 logs
2 logs
Sample throughput
78 samples/day
12 samples/day
Rate of success on first run
~ 90%
~ 50%
Days of testing
1 day
8 days*
Total analyst time
2 hours
50 hours
* 2 analysts for 3 days, 1 analyst for 5 days

Quantification of drug molecule in the mg/ml range

Shown here is the dynamic range for quantification of monoclonal IgG using Bioaffy 20 HC.

Quantification of drug molecule

Broad dynamic range for quantification of process-related impurities

By using a combination of CDs, the dynamic range can be extended even further, as shown here for HCP quantification, using Gyrolab 200 (crosses) and Gyrolab 20 HC (circles). The same set of reagents was used in both cases (Chinese Hamster Ovary HCP, Cygnus Technologies, USA).

Broad dynamic range for quantification of process related impurities
Extension of measurement range for HCP quantification,
using Bioaffy 200 (crosses)
and Bioaffy 20 HC (circles) respectively.

Quantification of drug product: Correlation between Gyrolab and HPLC

Results are generated more rapidly using Gyrolab compared to HPLC. At the same time, there is excellent correlation between the two methods, as shown here when quantifying monoclonal IgG in samples provided by AstraZeneca, Södertälje, Sweden – correlation between Gyrolab 20 HC and HPLC absorbance measurements at 280 nm.

Quantification of drug product: Correlation between Gyrolab and HPLC

Correlation between Bioaffy 20 HC and HPLC absorbance
measurements at 280 nm when quantifying monoclonal lgG in samples
provided by AstraZeneca.

Quantification of drug product: Correlation between Gyrolab and Biacore

In this example an IgG quantification assay, using Gyrolab with the 20 HC CD, showed very good correlation with a validated Biacore assay. Furthermore, the assay time could be reduced enormously using the Gyrolab platform. A total of 25 samples (n=9 per sample) were analyzed within 2.5 hours whereas the Biacore measurements took 15 hours.

Data presented by Rentschler Biotechnologie GmbH, Laupheim, Germany, at the 2nd EUFEPS and EAPB Workshop on Monoclonal Antibodies: Cutting-edge Science for New Medicines, Heidelberg June 3-5, 2008.

Correlation between Biacore and Gyrolab® results in lgG containing harvest
Correlation between Biacore and Gyrolab
results in lgG containing harvest

Quantification of contaminants: Monitoring cell-production development

Gyrolab is an excellent tool for monitoring the development of cell production over time, regarding both the intended IgG molecule and production of contaminating proteins. This example shows quantification of HCP in cell supernatant samples from GE Healthcare collected during cultivation of cells grown under different conditions, such as temperature and media composition.
Quantification of contaminants
Quantification of HCP in cell supernatant samples
from GE Healthcare collected during cultivation
of cells grown under different conditions.