FARMACI BIOLOGICI E BIOTECNOLOGICI

Module MODULO 3 TECNICA

The course aims to provide students with basic knowledge of the formulation, technological, and biopharmaceutical aspects of the delivery of biological and biotechnological drugs, with an overview of the regulatory framework for medical therapy and the different development phases.

The course is structured around lectures with the introduction of active learning practices.

Students will acquire knowledge of the general aspects of the formulation development of protein-based, nucleic acid-based, and cell-based drugs. They will also acquire knowledge of the general aspects of current regulations regarding the development of biotechnological drugs.

EXPECTED LEARNING OUTCOMES

At the end of the course, students will be able to:

- Acquire knowledge of the various formulation strategies used to deliver biological and biotechnological drugs. An overview of the manufacturing processes of pharmaceutical forms and basic knowledge of the quality control tests to be applied to the finished product before its distribution.

- Understand the difference between traditional medicines and biological and biotechnological medicines.

- Use the knowledge acquired during the mandatory pre-degree professional internship.

The course is organized in frontal lessons.

Basic knowledge of Mathematics and Statistics: linear regression analysis, Gaussian distribution, standard deviation – square root, graphical representation of analytical data on Cartesian axes, calculation of the unknown in proportions.

Basic knowledge of Organic Chemistry: esters, amides, amines, carboxylic acids, properties and reactivity of the main functional groups, phospholipids – glycerides, carbohydrates – starch and derivatives, polymers and polymerization, cellulose and derivatives.

Basic knowledge of Plant and Animal Biology: cell membrane (structure and properties), mechanisms of intracellular absorption, structure of the plant cell wall.

Basic knowledge of Physics: hydrodynamics, dynamic light scattering analysis, heat transfer methods, optical properties of materials (refraction, UV-vis spectrum, etc.).

Basic knowledge of Human Anatomy: gastrointestinal system, skin and skin appendages, blood-brain barrier, structure of the eye, mucosal tissues.

Basic knowledge of Microbiology and Applied Microbiology: sterility, sterilization, and validation assays, growth conditions for microorganisms, major pathogenic bacteria (E. coli, S. aureus, P. aeruginosa, Salmonellae), challenge tests.

Basic knowledge of Biochemistry: life processes and structure of the molecules that compose living organisms, understanding their function and manipulation for therapeutic purposes.

Basic knowledge of Pharmacology and Pharmacotherapy: pharmacokinetics - ADME.

Basic knowledge of Physiology: hemodynamics, physiology of the digestive system, lymphatic system.

Basic knowledge of English: understanding written papers.

Dosage forms (excipients, process, route of administration) for the delivery of:

- Monoclonal antibodies

- Oligonucleotides and gene therapy

- Vaccines

- Proteins

- CAR-T

Clinically used in: oncology, immunotherapy, infectious diseases, and notes on preclinical dosage forms.

Notes on the regulation of biological and biotechnological drugs. Biosimilars.

1. Francesca Calabrese e Giorgio Racagni. Principi di Biotecnologie Mediche e Farmaceutiche. Edizioni Edra. 2025

2. E. Vegeto, A. Maggi, P. Minghetti.    Farmaci Biotecnologici (aspetti farmacologici e clinici). Edizioni CEA. 2024.

3. Maria Luisa Calabrò. Compendio di Biotecnologie Farmaceutiche. Edizioni Edises. 2012