Case study: biosimilar anti TNFalpha (Adalimumab) analysis of Fc effector functions
نویسندگان
چکیده
Background For the development of biosimilar monoclonal antibodies or related substances containing the IgG Fc part it is mandatory to fully compare immunological properties between originator and biosimilar in a “comparability exercise” [1]. The important Fc associated functions to mediate antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) need to be characterized using both the active substance of the biosimilar and the comparator [2,3]. For testing anti TNFalpha antibodies target cells with stable expression of membrane TNFalpha (mTNFalpha) is required. Further prerequisites are test systems facilitating analysis with high precision and accuracy.
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