Ateneo - UPO

The module is designed to provide students with a fundamental understanding of the quality principles underlying biological and biotechnological medicinal products, emphasizing the critical role of the manufacturing process in determining product characteristics and ensuring quality, safety, and efficacy. The course will examine the main technological strategies used to design, develop, and maintain the quality of biological and biotechnological medicines throughout their lifecycle. Particular attention will be devoted to process variability management, Quality by Design (QbD) principles, and recent innovations in biopharmaceutical manufacturing technologies.

Crommelin D.J.A., Sindelar R.D., Meibohm B. Pharmaceutical Biotechnology – Fundamentals and Applications. Springer.Course materials, selected scientific articles, and case studies provided by the instructor.

The module provides the fundamental knowledge required to understand the principles of quality of biotechnological medicinal products from the perspective of pharmaceutical technology. The course explores the role of the manufacturing process in building product quality, examining how process design, process variability control, and modern manufacturing strategies contribute to ensuring the quality, safety, and efficacy of biopharmaceuticals throughout their entire lifecycle.

Students are expected to have a solid background in Pharmaceutical Technology, Molecular Biology and Biochemistry, including the fundamentals of drug development and manufacturing, recombinant protein production, the structure and function of biological macromolecules, and the basic principles of pharmaceutical quality.

Lectures supported by multimedia presentations, complemented by the discussion of case studies and practical examples related to the development and manufacturing of biotechnological medicinal products. Teaching activities are designed to encourage active student participation and to promote the application of pharmaceutical technology principles to real-world quality and safety challenges in biopharmaceutical development and manufacturing.

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 and/or oral examination designed to assess students' understanding of the principles of quality in biotechnological medicinal products, with particular emphasis on the role of the manufacturing process, process variability, and the technological strategies adopted in the development and industrial manufacturing of biopharmaceuticals.

Biotechnological medicinal products exhibit structural and manufacturing features that distinguish them from conventional small-molecule drugs. The course introduces the concept of quality in biopharmaceuticals, highlighting the critical role of the manufacturing process in determining product characteristics and illustrating the principle that "the process is the product."The main factors influencing the quality of biotechnological medicinal products will be discussed, with particular emphasis on biological and process-related variability, the relationship between manufacturing processes and product attributes, and the impact of these factors on product quality, safety, and efficacy.The course will examine pharmaceutical development strategies aimed at designing and maintaining product quality, focusing on manufacturing process control, monitoring of critical process parameters, and modern technologies used to ensure process robustness, consistency, and reproducibility in industrial biopharmaceutical manufacturing.The impact of manufacturing process changes throughout the product lifecycle will also be addressed, including the principles of product comparability and the scientific rationale underlying the development of biosimilar medicinal products.Finally, the course will present emerging technologies in biopharmaceutical manufacturing, with particular emphasis on continuous biomanufacturing, process digitalization, and the principles of Quality 4.0, through the discussion of industrial case studies.

Upon successful completion of the course, students will have acquired an understanding of the role of the manufacturing process in determining the characteristics of biological medicinal products that are relevant to quality, safety, and therapeutic efficacy. They will be able to critically evaluate the main sources of variability affecting industrial manufacturing and discuss the technological strategies adopted to design, monitor, and control manufacturing processes in order to ensure product consistency throughout the medicinal product lifecycle.