Quality Control and Analysis for Biopharmaceuticals

This course will provide the theoretical basis of the main spectroscopic (IR, NMR, CD), mass spectrometric analysis techniques such as IE, CI and ESI, DSC and XRPD. It will give to the student essential tools to determine the structure of organic and bioorganic compounds. Particular importance is given to the analysis of the data and the strategy for their interpretation, also through problems solving strategies. Basic notions will be given concerning the most popular analytical techniques applied for the characterization of biopharmaceuticals, including chromatography, capillary and gel electrophoresis, mass spectrometry as well as emission and absorption UV-Vis spectroscopy. Moreover, various procedures for potency (biological activity) testing will be shown, including ligand and receptor binding assays, cell culture-based assays, biochemical assays (such as enzymatic assays) and transgenic animal-based assays.

At the end of the course the student is expected 1) to prove a basic knowledge of the principles of the most popular analytical techniques for the characterization of biopharmaceuticals 2) to be able to plan analytical strategies for the characterization of biopharmaceuticals; 3) to be able to understand the results obtained from instrumental analyses of biopharmaceuticals; 4) to prove a basic knowledge of main methods employed for measuring biological activity of biopharmaceuticals; 5) to learn how to handle the spectroscopic data and to use them in an integrated and comparative way with the aim to extract all the information about the structure of organic and bioorganic molecules; 6) to be able to communicate clearly and with an appropriate language the knowledge and the acquired interpretative ability of the various spectra and 7) to develop a good autonomy for the identification of the structures of organic molecules.