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中国生物工程杂志

China Biotechnology
China Biotechnology  2015, Vol. 35 Issue (6): 101-108    DOI: 10.13523/j.cb.20150615
    
Progress in Research and Development of Bioactivity Determination of Antibody-based Therapeutics
WANG Lan, XU Gang-ling, GAO Kai, WANG Jun-zhi
National Institutes for Food and Drug Control, Beijing 100050, China
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Abstract  

Bioactivity determination of antibody-based therapeutics is essential in quality control.Presently, the main method to determine bioactivity is in vitro assay.Cell-based determination is widely used because of its advantages, such as simple operation, short period, good specificity and small variation, etc.In order to obtain the cell lines with ideal reactivity and simple detection method,construction of transgenic cell lines become one of the common strategies.In addition, some new technologies have rapidly been applied to evaluate the bioactivity of antibody drugs.Combined with the current research status and trend in development of bioactivity determination method, three aspects of antibody bioassay methods, which are based on cells, genetically modified cells and new technologies were described,thus providing new ideas for drug development and quality control.



Key wordsAntibody-based therapeutics      Bioactivity determination      Transgenic cell      Surface plasmon resonance      Homogeneous time-resolved fluorescence      Alpha technology     
Received: 26 January 2015      Published: 25 June 2015
ZTFLH:  R917  
Cite this article:

WANG Lan, XU Gang-ling, GAO Kai, WANG Jun-zhi. Progress in Research and Development of Bioactivity Determination of Antibody-based Therapeutics. China Biotechnology, 2015, 35(6): 101-108.

URL:

https://manu60.magtech.com.cn/biotech/10.13523/j.cb.20150615     OR     https://manu60.magtech.com.cn/biotech/Y2015/V35/I6/101


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