The manufacturing of Antibody-Drug Conjugates (ADCs) is intrinsically complex and a strong chemistry, manufacturing and control (CMC) strategy is vital due to the complex nature of these therapeutics and history of failures at both early and late stages. This training encompasses a comprehensive understanding of the primary technical and regulatory (FDA and EMA) challenges
US and EU regulatory authorities demand pediatric studies for new drugs, in the EU within “pediatric investigation plans“ (PIPs).The training on this very controversial topic offers industry professionals essential background knowledge from the perspective of drug development.
Mammalian cell culture plays a crucial role in the production of biopharmaceuticals, including monoclonal antibodies, recombinant proteins, and cell and gene therapies.Through a combination of theoretical learning and practical application, participants will gain the knowledge and skills necessary to optimize productivity, efficiency, and product quality in mammalian cell culture processes.
Technology transfer is a critical process in biopharmaceutical manufacturing, facilitating the transfer of processes, technologies, and knowledge between development and manufacturing sites. Through a combination of theoretical learning and practical application, participants will emerge equipped with the knowledge and skills to excel in technology transfer projects and drive innovation in biopharmaceutical manufacturing.
Nucleic acid therapeutics, including DNA, RNA, and PNA, hold tremendous promise for revolutionizing healthcare through their ability to target and modulate disease mechanisms at the molecular level. Through a combination of theoretical learning and practical application, participants will gain the knowledge and skills necessary to drive innovation and excellence in nucleic acid formulation and manufacturing.