( ...)Quality control of antibodies using the,,,2100 bioanalyzer and the Protein 200,,,Plus assay

Antibodies are commonly used in diagnostics, as research tools (for example protein arrays) or as biopharmaceutical therapeutics. In all cases the successful production of antibodies requires precise testing and quality control. The key quality criteria include: protein identification, quantitation and the monitoring of purity and stability. Agilent's 2100 bioanalyzer, the first commercial lab-on-a-chip analysis tool, developed in collaboration with Caliper Technologies Corporation, was used to verify the suitability of this technology for antibody quality control. The system allows sizing and analysis proteins of 5 to 200 kDa, depending on the application. In addition, it determines the relative quantitation based on internal standards for each sample, or absolute quantitation based on user-defined calibration standards. The microfabricated chips with distinct microfluidic channels allows antibody analysis under both reducing and non-reducing conditions in a single run. In this Application Note we demonstrate the use of the system for the evaluation of a stress stability test of two different antibodies.
Experiments and Results
Antibody samples were kindly provided from a customer in the pharmaceutical industry. For the first sample a stress stability test was performed for one month at 40 C, for the second sample the stress test was done for 12 weeks at 40 C. The standard samples and the stress test samples were analyzed under reducing conditions on the Agilent 2100 bioanalyzer using a Protein 200 Plus LabChip kit and the dedicated Protein 200 Plus software assay. All chips were prepared according to the protocol provided with the Protein 200 Plus LabChip kit. The kit includes 25 chips, spin filters and all the reagents needed for
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