Course Details

Production of biotechnological drugs

FA0311

Course
Production of biotechnological drugs
Code
FA0311
Academic Year
2025/2026
Curriculum Year
2024/2025
Degree Programme
PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY
Curriculum
000 - GENERICO
Course coordinator
Credits
9
Lecture Hours
72
Scientific Disciplinary Sector (SSD)
CHIM/04 - Industrial Chemistry, BIO/19 - General Microbiology, ING-IND/34 - Industrial Bioengineering
Course Type
Integrated learning activity
Course Delivery
OBB - Obbligatoria
Year
2
Teaching period
Secondo Semestre, Primo Semestre
Campus
NOVARA
Teaching language
Italian
Course Contents
The course aims to provide a comprehensive overview of the production of biotechnological drugs from a microbiological, chemical, and bioengineering perspective. It describes the characteristics and applications of the main microbial species of biotechnological and biopharmaceutical interest, as well as the methods for microbial cultivation, quantification, and product recovery in fermentation processes. Additionally, it offers a basic understanding of industrial biotechnologies, focusing on the characteristics of enzymes as catalysts and on the industrial biotransformation processes applied to the production of biologically active molecules. The importance of dynamic culture devices, such as bioreactors, for cultivating microorganisms, cells, and tissues is also described, along with in vitro model systems for studying drugs and diseases, their advantages, and practical examples.
Reference Texts
-Biotecnologie microbiche. Stefano Donadio. Casa Editrice Ambrosiana
- Microbiologia industriale. Matilde Manzoni. Casa Editrice Ambrosiana
- “Industrial Biotransformations” by A. Liese, K. Seelbach and C. Wandrey. Wiley-VCH. Material prepared by the teacher.
- Bioreactors. Design, Operation and Novel Applications. Edited by Carl-Fredrik Mandenius. ©2016 Wiley-VCH Verlag GmbH & Co. KGaA
Learning Outcomes
This course aims to provide students with a general knowledge of aspects related to the development and industrial production of biotechnological drugs currently on the market.
Specifically, the course will be divided into three modules each of which will explore one of the aspects of biotechnology applied to the pharmaceutical industry.
The microbiology applied to biopharmaceuticals module will aim to provide students with an overview of the fundamental aspects of microbial biotechnology, focusing on the use of microorganisms in the production of substances of biopharmaceutical interest and describing the characteristics of the main microorganisms of industrial interest and the main methodological approaches of fermentation processes.
The Industrial Biotechnology module will aim to provide students with basic knowledge of the main characteristics of enzymes and their applications as biocatalysts in organic and pharmaceutical synthesis, also with a view to the chemical industry's transition to a green approach to organic synthesis.
Finally, the Bioreactors module aims to enable the student to develop knowledge in the field of dynamic culture devices (bioreactors) for culturing microorganisms, cells and tissues and in vitro model systems for studying drugs and pathologies, in order to provide the student with the skills to evaluate the possible advantages of using bioreactors compared to traditional culture techniques depending on the field of application considered.
The course also aims to provide students with appropriate scientific vocabulary and critical thinking skills through reading and commenting on scientific articles.
Prerequisites
Basic knowledge regarding the structure and function of prokaryotic cells, microbial metabolism, and methods for cultivating and quantifying microbial cultures. Organic Chemistry I Basic knowledge of cell biology and physiology.
Teaching Methods
Microbiology in the Biopharmaceutical Field module: Lectures in presence with the support of slides that will be provided to students through the DIR platform. Some issues will be deepened with videos in English and Italian; classroom exercises will be carried out. Industrial Biotechnologies module: Lectures in classroom, exercises, and classroom discussion. Topics of particular interest will be explored with critical reading and commentary of scientific publications. Bioreactors module: Lessons in class with slides and illustration of scientific papers and applicative examples, supported by discussion of the most advanced technologies. All presented contents will be available on the digital platform (DIR) and will substitute the book content.
Additional Information
All contents presented during the lessons will be available on the digital platform Didattica in Rete dell’Ateneo (https://www.dir.uniupo.it/) Industrial Biotechnologies module: during the course, at the end of each key topic, the students will be involved in the critical analysis of examples of industrial processes. 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.
Assessment Methods
The exam will consist of three written tests related to the three modules of the course, conducted on the same day. The exam will include open-ended questions (2 for each module) aimed at assessing the knowledge and critical abilities acquired by the student, as well as multiple-choice questions. Each question will be assigned a specific score so that, for each module, the total sum will be a maximum of 32 (30 cum laude). Furthermore, the ability to answer to open-ended questions using appropriate technical-scientific language will be evaluated. During the written test, students are not allowed to consult textbooks, slides, notes, or multimedia devices. The final evaluation will be conducted collegially and shared among all the teachers of the individual modules. There are two exam sessions scheduled in the months of February, June-July, and September.
Detailed Syllabus
Microbiology in the Biopharmaceutical Field module:• Bioprospecting: exploration of microbial biodiversity for biotechnological purposes • Industrial use of microorganisms • Isolation and selection of microorganisms of pharmaceutical interest • Microorganisms of biotechnological and biopharmaceutical interest: E. coli - Streptomyces - Bacillus - Yeasts - Filamentous fungi • Methods of microbial cultivation • Evaluation of microbial development in industrial processes • Introduction to procedures for obtaining microbial metabolites, measurements, regulation, and technologies in fermentation processes • Improvement of production processes • Overview of methods for recovering biotechnological products • Molecular basis of production processes: some examples - Primary metabolites - Antibiotics - Vitamins. Gender Dimension Integration: The course will include brief insights into women scientists whose contributions to the development of microbiology were essential but often underrecognized. The aim is to raise students’ awareness of the importance of inclusion, gender equality, and equity in science. Industrial Biotechnologies module: Biotransformations: definitions and characteristics. Comparison between chemical synthesis and biocatalyzed reactions. Enzyme structure, functions, mechanisms, and scope in organic synthesis. Specificity, selectivity of enzymes and methods for the study of enzymatic properties. Main classes of enzymes used in organic synthesis and in the chemical industry: Oxidoreductases -Transferases -Hydrolases -Lyases -Isomerases -Ligases Biotransformations to produce products of pharmaceutical relevance: examples of industrial processes. Bioreactors module: From 2D static culture to 3D dynamic culture (1h) • Definition of devices for dynamic culture of microrganisms/cells/tissues (bioreactors) and advantages for basic research and large-scale industrial production (2h) • Bioreactor types and purposes in tissue engineering field (3h) • Bioreactor subsystems (3h) • Cell expansion bioreactors (2h) • Tissue maturation bioreactors (3h) • In vitro model system for drug screening and disease modeling / Microfluidic bioreactors (2h)
Expected Learning Outcomes
KNOWLEDGE AND UNDERSTANDING: The student will acquire knowledge and understanding related to the applications of the main methodologies used in the production of molecules of pharmaceutical interest, biotechnological applications in organic synthesis, and the use of bioreactors. Specifically, the student will gain knowledge about some of the technologies used for microbial transformations, methodologies for selecting microorganisms of pharmaceutical interest, the use of growth substrates, and techniques for quantifying microbial development in the pharmaceutical and industrial fields. Furthermore, they will learn to understand the key properties of enzymes and acquire knowledge about their application as catalysts in the organic synthesis of molecules of pharmaceutical interest. This will be complemented by acquiring knowledge about the characteristics and constituent subsystems of bioreactors and their purposes of use, with a focus on bioreactors for cell expansion and in vitro model system studies at different scales, with particular attention to the implications/advantages of using bioreactors in production processes.
ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING: The student will be provided with both a theoretical framework and the tools for applying the main microbiological methodologies and processes, the use of enzymes as catalysts, and the use of bioreactors currently employed in the pharmaceutical and industrial sectors. This will enable them to critically select the use of the described methodologies, develop and further enhance competencies in the microbiological field, identify the best synthetic strategy for a particular chemical transformation, identify essential parameters to monitor and control in the bioreactor, and select the most appropriate bioreactor for a given application.
AUTONOMY OF JUDGEMENT AND COMMUNICATION SKILLS: At the end of the course, the student should demonstrate autonomy of judgment, be capable of analyzing operational criticalities, and take appropriate corrective measures in microbiological aspects, the use of enzymes as catalysts, and the application of bioreactors in pharmaceutical and industrial contexts. They will also have acquired skills in verbal and written communication using appropriate technical-scientific language. Additionally, they will develop the ability to independently learn new knowledge using the provided materials, such as slides and scientific articles, and gain critical thinking skills to make comparative choices and express judgments while being able to engage in discussions on relevant topics covered in the course.

Moduli

Course year 2
Code FA0314
Course Industrial biotechnology
Lecturers Katia SPARNACCI
SSD CHIM/04
Campus NOVARA
Curriculum GENERICO
Credits 2
Course year 2
Code FA0312
Course Microbiology in the biopharmaceutical field
Lecturers Letizia FRACCHIA
SSD BIO/19
Campus NOVARA
Curriculum GENERICO
Credits 5
Course year 2
Code FA0313
Course Bioreactors
Lecturers Stefano Gabetti
SSD ING-IND/34
Campus NOVARA
Curriculum GENERICO
Credits 2
Last update:09-09-2026 00:14:31