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Strategy of Structural Analysis for Biosimilar Monoclonal Antibody Drug |
JIA Wei, CHEN Xi, ZHOU Chun-xi, SONG Lan-kun |
Waters Technologies Shanghai Limited, Shanghai 100026, China |
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Abstract The patent protection period of many monoclonal antibody drugs will expire, which market value will be over a hundred billion dollars. It is very important for developing countries to improve their medical system and upgrade industries. But, there are huge difficulties in developing biosimilar monoclonal antibody, which must use LCMS system to overcome. How to use LCMS system to get required data item for biosimilar monoclonal antibody was shown. Besides techniques, the work efficiency and law requirements for biosimilar drug production were also discussed.
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Received: 29 June 2012
Published: 25 October 2012
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