Biologies mAbs

Biotechnology and Biological Preparations Table 10 Approved biologicals (Mabs) 273... 

Vandenbroeck et al.7 used an ELISA to determine the recovery of immu-noreactive porcine interferon-gamma (IFN-y) from E. coli inclusion bodies. The ELISA used a polyclonal coating antibody with detection by a MAb. The inclusion bodies were solubilized in diluted 6 M guanidine/HCl and IFN subsequently refolded by its removal. The antiviral activity of the interferon was measured with a bioassay using the cytopathic effect (CPE) of vesicular stomatitis virus (VSV) on bovine kidney cells. The results of this study showed that the immu-noreactivity measured by ELISA matched the biological activity measured by bioassay. 

Recombinant human IL-11 was under evaluation in human clinical trials for use as a thrombopoietin product for chemotherapy support.18 An ELISA was developed to measure adsorption (residual concentration in various containers over time). The ELISA was formatted with an anti-IL-11 MAb for capture and a biotinylated antibody for detection.18 A combination of HSA and Tween-20 was required to address both the adsorption of IL-11 to glass and retention of biological activity postlyophilization. 

In most examples in the literature, polyclonal antibodies are used for preparing such columns but the increasing availability of monoclonal antibodies (MAbs) should lead to affinity gels based on MAbs becoming available. Such specificity would be particularly valuable where peptide drugs have to be selectively extracted from biological matrices prior to analysis. 

Brodzik, R., Glogowska, M., Bandurska, K., Okuliez, M., Deka, D., Ko, K., van der Linden, J., Leusen, J.H., Pogrebnyak, N., Golovkin, M., Steplewski, Z., and Koprowski, H. (2006). Plant-derived anti-Lewis Y MAb exhibits biological activities for immunotherapy against human cancer cells. Proc. Natl. Acad. Sci. U.S.A. 103(23) 8804-8809. 

In summary, only a few therapeutic polyclonal antibodies are still marketed today. The main advantages of mAbs are their high specificity towards the target and the capability of an unlimited production of these homogeneous biological molecules. In future, new antibody or antibody-derived pharmaceuticals will be developed and can be expected to have favorable efficacy, a lack of immunogeni-city, and appropriate pharmacokinetics such that they can be used to treat intracellular medical disorders. 

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