This guidance is intended to provide recommendations to sponsors and applicants on the use of
monoclonal antibodies (mAbs) as reagents in the manufacture of drug substances2 that are regulated by
the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and
Research (CBER). The guidance focuses on the chemistry, manufacturing, and control (CMC) issues
that should be addressed in new drug applications (NDAs), abbreviated new drug applications
(ANDAs), biologics license applications (BLAs), supplements to these applications, or investigational
new drug applications (INDs).
This document presents issues associated with and recommendations on the documentation to support
the use of mAb reagents generated by hybridoma technology or production of recombinant mAb or
their fragments in bacteria, including phage display technology, fungi (yeasts and molds), and nonprimate
animal-derived transfected cell lines. Monoclonal antibodies or their fragments generated by other
methods can present additional concerns. The recommendations provided in this document should be
considered when such materials are used; however, the guidance does not address the particular
method of production of the mAbs or their fragments.
This document does not provide recommendations on mAbs that are used as diagnostics, radiolabeled
imaging agents, or therapeutic products. For a discussion of mAb products for human therapeutic or
diagnostic use please refer to the Points to Consider in the Manufacture and Testing of Monoclonal
Antibody Products for Human Use (PTC 1997).3 The recommendations for characterization and
testing for mAbs used as parenteral pharmaceuticals are by necessity stringent, and not all of them are
applicable to mAbs that are used as reagents in drug manufacturing.
More details, please click here: Monoclonal Antibodies Used as Reagents in Drug Manufacturing.