Analytical and Formulation Strategies in Biotechnological Drug Discovery

The course aims at providing knowledge of the general principles and requirements for the design, development and formulation of new biotechnological medicinal products. The main bioanalysis and formulation techniques used in this field will be covered, providing the theoretical basis for planning and performing analyses aimed at evaluating pharmacokinetics, stability, and potential off-target effects, as well as for interpreting the results obtained. Regulatory aspects related to clinical trials and obtaining the Marketing Authorisation (MA) of new biotechnological medicinal products will also be examined.

At the end of the course, the student will acquire principles required to design biotechnological medicinal products, based on the specific properties of the active substance and the therapeutic requirements. Specifically, the student will be expected to: 1) prove a basic knowledge of the principles of the analytical and formulation techniques disclosed into the course 2) be able to figure out methodologies for the design, formulation and characterization of biopharmaceuticals; 3) be able to understand the results obtained from instrumental analyses; 4) clearly present and with a proper language theoretical concepts and personal interpretation concerning the topics disclosed into the course and 5) be able to refer to technical, scientific and regulatory sources related to the topics covered in the course.