Discovering biopharmaceuticals: key development stages, regulatory framework, and manufacturing processes

This activity presents the specificities of biopharmaceuticals compared to chemical drugs, identifying their different types and characteristics. It also describes the key stages of their development, the role of CMC activities (Chemistry, Manufacturing and Controls), and the fundamentals of the regulatory framework and bioproduction requirements.

This activity covers the key stages of a bioproduction process through examples of monoclonal antibodies and vaccines, presenting Upstream (USP) (cell culture), Downstream (DSP) (purification), and Fill & Finish (formulation and packaging). It also introduces Advanced Therapy Medicinal Products (ATMPs) as cutting-edge medical solutions and presents the specific aspects of their manufacturing.