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.

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.

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.

The main factors influencing the quality of biotechnological medicinal products will be examined, with particular emphasis on biological and technological variability, the relationship between process parameters and critical quality attributes, and their potential implications for product safety and therapeutic efficacy.
The course will explore pharmaceutical development strategies aimed at designing robust and reproducible manufacturing processes through the application of Quality by Design principles to biotechnological medicinal products. Topics will include the identification of critical quality attributes, the assessment of factors influencing their variability, and strategies for monitoring and controlling manufacturing processes, with particular attention to maintaining product quality during industrial manufacturing.
The technological challenges associated with transferring manufacturing processes from laboratory to industrial scale will also be examined, together with the effects of manufacturing process changes throughout the medicinal product lifecycle. The principles of product comparability and the scientific rationale underlying the development of biosimilar medicinal products will be discussed.
The course contents will be explored through the analysis and discussion of case studies and practical examples, with the aim of highlighting the role of technological strategies in ensuring the quality, safety, and efficacy of medicinal products throughout their lifecycle.

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.