Description
This course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products, such as those based on mAbs, differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.
In this course, we focus on distinctive issues in the production and testing of mAbs, in the context of relevant regulatory guidance. We discuss manufacturing quality, nonclinical, and clinical issues. We address aspects specific to radiolabeled mAbs. Finally, we identify the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA.
Procedures for making regulatory submissions for monoclonal antibodies are discussed, such as the marketing authorization application through the CP (Centralized Procedure) in Europe, and by a BLA (Biologics License Application) in the USA. Orphan drug status and its effect on clinical design are also covered. The course addresses the impact of recent developments in production techniques on the regulatory landscape, and will serve as a good source of reference all developments in the future and their practical consequences.
