Monoclonal Antibodies Quality & Regulatory Requirements

Monoclonal Antibodies have developed and evolved from the early forms derived in ascitic fluid to multibillion drugs manufactured in ton quantities. In the early days of Monoclonal antibody development, the approaches now considered routine such a biosimilars and Antibody Drug Conjugates were not considered as feasible, yet they are. The current guidance and approaches offer significant flexibility within the regulatory framework, yet the industry still adopts a more conservative approach.

This course will encourage the adoption and the utilisation of the full extent of the current regulatory guidance and share practical examples as to how to achieve.