The Challenge of Packaging Complex Medicines

Synopsis

This presentation looks at the key challenges in packaging complex medicines like biologics, gene therapies, and new mRNA drugs. It highlights the challenges of deep freezing in gene therapies and discusses the risks from leachables extractables, which can change the pH of complex pharmaceuticals. These changes can lead to issues like protein clumping, the creation of solid particles, and the inactivation of important drugs, such as monoclonal antibodies. Addressing the importance of evaluating different specialty packaging options during early stability studies to reduces these risks and ensure that the drugs remain effective throughout their lifecycle.