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| Establishment of Homogeneous Time-resolved Fluorescence (HTRF) Method for Measurement of Monoclonal Antibody Concentration |
| DENG Chun-pin, QIN Yu-min, DENG Qiao-chun, WANG Bo, PENG Yu-cai |
| Livzon Mabpharma Inc, Zhuhai 519020, China |
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Abstract A rapid and simple antibody analysis method based on HTRF technology was established to measure concentration of recombinant monoclonal antibody in both cell culture medium and purified antibody solution. APC-labeled antigen,antibody samples or controls, and Eu-labeled anti-human IgG are added into 96 well plate (Black), incubate for some time, followed by fluorescence reading with microplate reader. Standard curve was generated by 4-PL model, antibody concentration in tested samples was calculated accordingly by software. The method qualification results showed that the method is antigen-antibody specific, with accuracy close to 98.9%, precision close to 4.3%, and linearity range 25～1000 ng/ml. This method can be used for cell line screening, bio-process monitoring, and quality control during antibody drug development.
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Received: 15 August 2013
Published: 25 December 2013
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