90827 - Safety Pharmacology and Toxicology of Biopharmaceuticals

Learning outcomes

The course aims to provide students with a solid introduction to the fundamental analytical techniques for the quality control of biotechnological drugs, with a particular focus on chromatographic methodologies and mass spectrometry. The basic theoretical principles and key practical applications will be presented, highlighting the crucial role of these techniques in ensuring product quality and safety throughout the drug's life cycle. Through an integrated approach combining theory and case studies, the course aims to provide the foundation needed to recognize critical issues related to the characterization and stability of biologics. Particular attention will be paid to critical quality attributes, stability assessment, and the evolution of the biosimilar and biobetter landscape. Upon completion of the course, students will: - Understand the central role of quality control in ensuring the safety, efficacy, and quality of biotechnological drugs throughout the product's life cycle; - Has the tools to understand issues related to the quality, biosafety, and microheterogeneity of biological and biotechnological products, including their manufacturing process. - Has a basic understanding of the critical quality attributes (Critical Quality Attributes) relevant to biotechnological drugs, with reference to their impact on product safety and efficacy. - Has knowledge of the basic principles and operation of the main chromatographic techniques and the fundamentals of mass spectrometry and is able to integrate this knowledge to evaluate critical quality and stability attributes of biological drugs. - Has acquired the fundamental concepts related to the comparative studies required for the characterization of biosimilars and biobetters, understanding the analytical differences compared to originator drugs. Furthermore, the course aims to provide students with an overview of the discovery and development phases of a new biotechnological drug, with particular attention to safety aspects, the cellular and molecular mechanisms of toxicity of biotechnological drugs, and the systemic toxicity of biotechnological drugs in organs and systems.

Syllabus

Office hours

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