REVIEWS  RADIOIMMUNOTHERAPY
Guest Editor: S. J. Mather 

The Quarterly Journal of Nuclear Medicine and Molecular Imaging 2004 December;48(4):258-66

Copyright © 2009 EDIZIONI MINERVA MEDICA

language: English

Design and manufacture of monoclonal antibodies for radioimmunotherapy

Hale G., Berrie E., Bird P.

Sir William Dunn School of Pathology University of Oxford, Oxford, UK

Appropriate ­design and man­u­fac­ture of mono­clo­nal anti­bod­ies is fun­da­men­tal to ­their use for radio­im­mu­no­ther­a­py. Besides the ­right selec­tion of anti­body spec­i­fic­ity and affin­ity, recom­bi­nant anti­bod­ies can be ­designed to sim­pli­fy man­u­fac­ture and min­i­mise unwant­ed ­side ­effects. Although ­many inno­va­tive new tech­nol­o­gies ­have ­been devel­oped in ­recent ­years, anti­bod­ies are ­still ­most com­mon­ly pro­duced ­from mam­mal­ian ­cells and pur­i­fied by col­umn chrom­a­tog­ra­phy. Purification meth­ods ­have to be ­designed and val­i­dat­ed to ­remove poten­tial con­tam­i­nants, espe­cial­ly ret­ro­vi­rus­es, ­which in prin­ci­ple ­might be ­present in mam­mal­ian ­cell ­lines. Adherence to rel­e­vant “Good Manufacturing Practices” is man­da­to­ry in the pro­duc­tion of any medic­i­nal prod­uct and ­there are numer­ous guide­lines regard­ing the man­u­fac­ture of anti­bod­ies. This arti­cle out­lines ­some meth­ods ­used for fer­men­ta­tion, pur­ifi­ca­tion and qual­ity con­trol of anti­bod­ies intend­ed for radio­la­bel­ling.