Ateneo - UPO

The course will deal with the theoretical principles and operating modes of the main analytical techniques employed in the characterization and quality control of biotherapeutics.

• J.R. Lill, W. Sandoval; Analytical Characterization of Biotherapeutics – Wiley
• M.S. Lee, Q.C. Ji; Protein Analysis using Mass Spectrometry – Wiley
• W.O. Foye; Principi di Chimica Farmaceutica – Piccin editore

The evaluation of the quality of pharmaceutical products obtained with biotechnological processes requires a complete and detailed structural characterization, the qualitative and quantitative analysis of impurities and contaminants and the evaluation of biological activity. By attending the course, the student will be able to recognize and apply the most common analytical techniques employed for the specific characterization of biotherapeutics.

Fundamentals of liquid chromatography coupled to mass spectrometry techniques.

Frontal lessons and discussion of case studies.

Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities

Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

Written exam with the other modules of the course "Advanced biopharmaceutical applications"

• Pharmaceutical aspects of biotherapeutics: therapeutic proteins, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), other types of conjugates. • Post translational modifications: glycosylation profiles and analytical strategies for their determination. • Chemical degradation of therapeutic proteins, examples of the reactions involved. • Quality control of biotherapeutics: definition of quality, implementation of a quality assurance system, identification of the critical quality attributes (CQAs) of biotherapeutics. ICH guidelines: stability (ICH Q5C), specification (ICH QB6), comparability (ICH QE5). • Fundamentals of the most common analytical techniques employed in the characterization and quality control of biotherapeutics. Examples of applications. Separative techniques: HPLC (SEC, HILIC, IEX, HIC, AC), capillary electrophoresis CE (CZE, MEKC, CIEF). Detectors: UV-Vis, FL, MS. Ion sources: ESI, MALDI, triple qualdrupole (QQQ) and operative modes in tandem analysis, qTOF, Orbitrap, ion traps. Analytical approaches based on mass spectrometry operative modes.

By attending the course, the student will be able to recognize and apply the analytical techniques for the characterization of biotherapeutics products according to their physic-chemical properties and quality requirements.