Ateneo - UPO

The course addresses the principles of formulation development and manufacturing of biotechnological and biological medicinal products, illustrating how the physicochemical and biopharmaceutical properties of the active substance guide formulation design, manufacturing process selection, and the definition of the quality attributes of the final medicinal product. Following an introduction to the fundamentals of preformulation and biopharmaceutics, the course examines the major pharmaceutical dosage forms and the related formulation and manufacturing technologies. It then focuses on the specific challenges associated with biotechnological medicinal products, with particular emphasis on the biopharmaceutics of therapeutic proteins, protein degradation and stabilization, immunogenicity, industrial manufacturing, purification, and quality control. The course concludes with the study of advanced drug delivery strategies for biotechnological medicinal products, including PEGylation and bioconjugation, micro- and nanoparticulate delivery systems, and drug targeting.

Paolo Caliceti, Tecnologia farmaceutica, 2025, CEA Casa Editrice Ambrosiana. Aulton ME, Taylor K.M.G. Tecnologie farmaceutiche, 2015 EDRA LSWR. Farmacopea Ufficiale Italiana edizione vigente. Farmacopea Europea edizione vigente. Daan J. A. Crommelin, Robert D. Sindelar, Bernd Meibohm. Pharmaceutical biotechnology. Ed. Springer Nature; 5° edizione

The course aims to provide students with the theoretical knowledge and methodological tools required to understand, design, and critically evaluate formulation strategies for the development of medicinal products, with particular emphasis on biotechnological and biological medicines. By the end of the course, students will be able to interpret the relationships between the physicochemical and biopharmaceutical properties of the active substance, pharmaceutical dosage form selection, manufacturing processes, and the quality attributes of the final medicinal product, justifying the main technological choices according to therapeutic and manufacturing requirements. Students will also be able to critically analyse the specific challenges associated with biological medicines, understand the strategies adopted to improve their stability, and discuss modern drug delivery and site-specific targeting technologies using appropriate scientific terminology.

There are no formal prerequisite courses. However, to fully benefit from the course, students are expected to have a basic background in chemistry, physics, biochemistry, cell and molecular biology, physiology, and pharmacology.

The course will be delivered mainly in form of lectures. Some seminars are planned, carried out by experienced people from pharmaceutical industry, which will illustrate the practical application of the exposed theoretical concepts. Occasionally, students will be invited to respond jointly to questions on topics already treated and to recover supplementary educational material on AIFA, EMA and FDA web sites

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.

The assessment may be taken either in written or oral form. To successfully complete the course, students must demonstrate that they have understood and are able to apply the fundamental concepts covered throughout the course. The final grade, expressed on a 30-point scale, will be based on the following criteria: (1) knowledge and understanding of the theoretical and applied aspects of the topics covered; (2) ability to critically evaluate and establish connections among the different topics; (3) communication skills and appropriate use of scientific and technical terminology; and (4) learning skills.

The course introduces the principles of formulation development for biotechnological and biological medicinal products, highlighting the role of pharmaceutical technology in the design of safe, effective, and high-quality formulations. The course progressively guides students from the characterization of the active substance to the development of advanced drug delivery systems, providing the scientific and technological tools required to understand how the properties of a molecule influence formulation design, manufacturing processes, and drug release strategies.
The course begins with the fundamentals of preformulation and biopharmaceutics, focusing on the physicochemical properties of the active substance and their role in formulation design and drug bioavailability. It then examines dispersed systems and the main liquid pharmaceutical dosage forms, including solutions, suspensions, emulsions, and colloidal dispersions, followed by the study of pharmaceutical powders, their properties, and their applications in the development of solid dosage forms. Granulation and pelletization processes, capsules, and tablets are subsequently presented, with particular emphasis on manufacturing technologies, drug release mechanisms, and pharmacopoeial quality control tests.
The course continues with parenteral dosage forms and the principal drying technologies used in pharmaceutical development, namely spray drying and freeze-drying, highlighting their role in the formulation and stabilization of medicinal products.
The second part of the course focuses on biotechnological and biological medicinal products. It covers the biopharmaceutics of therapeutic proteins, the main mechanisms of protein degradation and stabilization, immunogenicity, the principles of industrial manufacturing, purification techniques, quality control, and formulation aspects of protein therapeutics, with particular emphasis on insulin formulations. The basic principles of PEGylation and bioconjugation are also introduced as examples of strategies used to modify the properties of protein therapeutics.
The course concludes with advanced drug delivery systems, focusing on the characteristics of microcapsules and microspheres, the main preparation technologies for microparticulate systems, and the fundamentals of nanoparticulate delivery systems and drug targeting.

Knowledge and understanding
By the end of the course, students will have acquired a thorough understanding of the principles underlying the formulation development and manufacturing of biotechnological and biological medicinal products. They will understand the relationships between the physicochemical and biopharmaceutical properties of the active substance, pharmaceutical dosage form selection, manufacturing processes, and the quality attributes of the final medicinal product, as well as the scientific principles underlying the formulation of protein therapeutics and advanced drug delivery systems.
Applying knowledge and understanding
Students will be able to apply the acquired knowledge to analyse and justify the main formulation and technological choices involved in medicinal product development. They will be able to interpret the influence of the physicochemical properties of the active substance on formulation design, evaluate the challenges associated with the stability of protein therapeutics, and discuss the main strategies used for drug delivery and site-specific targeting.
Making judgements
Students will develop the ability to critically evaluate different formulation and manufacturing strategies by comparing their advantages, limitations, and fields of application. They will also be able to analyse technological issues related to medicinal product development and identify the most appropriate formulation approaches according to the characteristics of the active substance and the intended therapeutic objectives.
Communication skills
Students will be able to describe and discuss the topics covered in the course using appropriate scientific and technical terminology, presenting formulation development, manufacturing, and drug delivery concepts with clarity and scientific rigour.
Learning skills
Students will acquire the methodological tools required to independently deepen their knowledge of scientific and technological advances in pharmaceutical technology and the development of biotechnological medicinal products. They will be able to critically interpret the scientific literature and keep up to date with recent advances in formulation science and advanced drug delivery systems.