The production and use of monoclonal antibodies (mAbs) in the in-vivo diagnosis and treatment of human diseases has evolved exponentially in recent years.

This module identifies the key manufacturing issues and the concerns associated with mAb production. Setting of specifications is also discussed. Requirements on preclinical and clinical studies are set out. Special requirements for radio-labelled mAbs are described. Procedures for making regulatory submissions for mAbs are detailed: marketing authorisation application through the Centralised Procedure (CP) in Europe, and by a Biologics License Application (BLA) in the USA. Orphan drug status and its effect on clinical design are addressed. The module discusses the impact of recent developments in production techniques on the regulatory landscape and will serve as an effective reference source on future developments and their practical consequences.


Who will benefit from this module?
Individuals working on the research and development of monoclonal antibodies, on clinical trials, in regulatory affairs, or otherwise involved in the preparation of regulatory submissions. Those needing to improve their understanding of monoclonal antibodies for registration will find this module invaluable.