Pharmaceutical Biotechnology

Educational objectives

General objectives
The Physical Methods in Organic Chemistry and Radiochemistry course aims to provide students with fundamental knowledge of modern chromatographic, spectroscopic and mass spectrometric techniques, commonly used in the study of organic molecules both in the research field and in control laboratories. The course also aims to provide the ability to identify the most suitable chromatographic techniques for solving real problems, and to understand UV, IR, MS and NMR spectra of organic molecules of biotechnological interest. Basic knowledge of nuclear chemistry, preparation and use of radiopharmaceuticals for diagnostic and therapeutic purposes are also provided. At the end of the course, students will acquire the skills to analyse NMR, IR and MS spectra, to derive the structure of unknown compounds from their combined analysis, and to predict the spectroscopic properties of new compounds.

Specific objectives
1. Knowledge and understanding
The student knows and understands the fundamentals of modern chromatographic techniques: adsorption, partition, thermodynamic aspects, van Deemter equation, composition and morphology of stationary phases, simple structure-retention relationships, solute-stationary phase-mobile phase interaction. The student knows the different elution modes in liquid chromatography (NP, RP, HILIC, PIC-LC, HIC). The student also knows and understands the fundamentals of spectroscopic techniques: matter-radiation interaction, the electromagnetic spectrum, wavelength, frequency, energy content, radiation intensity, absorption, emission, scattering, excited states, quantization. The student knows and understands the theoretical principles and practical applications of IR spectroscopies (harmonic oscillator, anharmonic oscillator, fundamental vibrations, overtone, combination bands, characteristic absorptions of the main functional groups), 1H-NMR and 13C-NMR (nuclei in a magnetic field, resonance, relaxation processes, screen and screen constants, homo- and hetero-nuclear spin-spin coupling, spin systems and Pople notation, Karplus relation). The student knows and understands the main ionization and fragmentation processes underlying the different mass spectrometry techniques; he/she knows the main ion sources and mass analysers suitable for the study of organic molecules and biological macromolecules. He/she is also able to interpret the mass spectrum of model compounds of pharmaceutical and biotechnological interest. The student knows and understands the theoretical principles and practical applications of coupled instrumental techniques (LC-MS), and can understand how the spectral parameters can be influenced by the experimental conditions (physical state of the sample, concentration, solvent, temperature). The student will also be able to determine the decays of unstable isotopes, and the type of radiation emitted, the main radiopharmaceuticals used in diagnostics and therapeutics in relation to the different districts of the organism.
2. Applying knowledge and understanding
The student is able to select the most suitable chromatographic technique based on the structure of the compounds to be analysed and is able to describe the process for the choice of stationary phases, mobile phases and detectors. He/she is able to control and optimize the kinetic and thermodynamic parameters of the chromatographic process and is able to apply the acquired knowledge to new problems typical of research contexts and in the workplace. The student is able to interpret IR, NMR, MS spectra of simple pure organic compounds, and is able to choose the spectroscopic technique or the combination of more techniques suitable for the different structural investigations (control of the conversion of functional groups, identification of impurities). The student is able to apply the known instrumental techniques to new problems that may arise in research or work contexts. At the end of the course the student will know the decay mechanisms and the radiation emitted by a radioelement and the main radiopharmaceuticals used in nuclear medicine, both in diagnostics and therapy.
3. Making judgement
The student is able to broaden and to extend the knowledge acquired during the Master's Degree course with skills relevant to the pharmaceutical aspects that characterize the Specialist Degree Course. The student will be able to independently select the proper analytical method for a specific analytical problem. He/she will also be able to acquire from databases and understand multispectral data useful for solving typical problems in research and production areas such as synthesis laboratories, quality control of active ingredients labs, laboratories of natural products analysis, as well as analysis of complex mixtures and metabolites. These skills are particularly stimulated and developed by carrying out spectral interpretation exercises during lectures and tutorials..
4. Communication
The student will be able to communicate what he/she has learned in a clear and rigorous manner, both to non-expert talkers and to experts in the field. The student is stimulated to interpersonal communication during lectures and classroom exercises.
5. Learning skills
The student will have developed autonomous learning skills related to chromatographic, spectroscopic and spectrometric techniques through the consultation of databases, bibliographic material and scientific literature available online.

Educational objectives

General objectives
The Physical Methods in Organic Chemistry and Radiochemistry course aims to provide students with fundamental knowledge of modern chromatographic, spectroscopic and mass spectrometric techniques, commonly used in the study of organic molecules both in the research field and in control laboratories. The course also aims to provide the ability to identify the most suitable chromatographic techniques for solving real problems, and to understand UV, IR, MS and NMR spectra of organic molecules of biotechnological interest. Basic knowledge of nuclear chemistry, preparation and use of radiopharmaceuticals for diagnostic and therapeutic purposes are also provided. At the end of the course, students will acquire the skills to analyse NMR, IR and MS spectra, to derive the structure of unknown compounds from their combined analysis, and to predict the spectroscopic properties of new compounds.

Specific objectives
1. Knowledge and understanding
The student knows and understands the fundamentals of modern chromatographic techniques: adsorption, partition, thermodynamic aspects, van Deemter equation, composition and morphology of stationary phases, simple structure-retention relationships, solute-stationary phase-mobile phase interaction. The student knows the different elution modes in liquid chromatography (NP, RP, HILIC, PIC-LC, HIC). The student also knows and understands the fundamentals of spectroscopic techniques: matter-radiation interaction, the electromagnetic spectrum, wavelength, frequency, energy content, radiation intensity, absorption, emission, scattering, excited states, quantization. The student knows and understands the theoretical principles and practical applications of IR spectroscopies (harmonic oscillator, anharmonic oscillator, fundamental vibrations, overtone, combination bands, characteristic absorptions of the main functional groups), 1H-NMR and 13C-NMR (nuclei in a magnetic field, resonance, relaxation processes, screen and screen constants, homo- and hetero-nuclear spin-spin coupling, spin systems and Pople notation, Karplus relation). The student knows and understands the main ionization and fragmentation processes underlying the different mass spectrometry techniques; he/she knows the main ion sources and mass analysers suitable for the study of organic molecules and biological macromolecules. He/she is also able to interpret the mass spectrum of model compounds of pharmaceutical and biotechnological interest. The student knows and understands the theoretical principles and practical applications of coupled instrumental techniques (LC-MS), and can understand how the spectral parameters can be influenced by the experimental conditions (physical state of the sample, concentration, solvent, temperature). The student will also be able to determine the decays of unstable isotopes, and the type of radiation emitted, the main radiopharmaceuticals used in diagnostics and therapeutics in relation to the different districts of the organism.
2. Applying knowledge and understanding
The student is able to select the most suitable chromatographic technique based on the structure of the compounds to be analysed and is able to describe the process for the choice of stationary phases, mobile phases and detectors. He/she is able to control and optimize the kinetic and thermodynamic parameters of the chromatographic process and is able to apply the acquired knowledge to new problems typical of research contexts and in the workplace. The student is able to interpret IR, NMR, MS spectra of simple pure organic compounds, and is able to choose the spectroscopic technique or the combination of more techniques suitable for the different structural investigations (control of the conversion of functional groups, identification of impurities). The student is able to apply the known instrumental techniques to new problems that may arise in research or work contexts. At the end of the course the student will know the decay mechanisms and the radiation emitted by a radioelement and the main radiopharmaceuticals used in nuclear medicine, both in diagnostics and therapy.
3. Making judgement
The student is able to broaden and to extend the knowledge acquired during the Master's Degree course with skills relevant to the pharmaceutical aspects that characterize the Specialist Degree Course. The student will be able to independently select the proper analytical method for a specific analytical problem. He/she will also be able to acquire from databases and understand multispectral data useful for solving typical problems in research and production areas such as synthesis laboratories, quality control of active ingredients labs, laboratories of natural products analysis, as well as analysis of complex mixtures and metabolites. These skills are particularly stimulated and developed by carrying out spectral interpretation exercises during lectures and tutorials..
4. Communication
The student will be able to communicate what he/she has learned in a clear and rigorous manner, both to non-expert talkers and to experts in the field. The student is stimulated to interpersonal communication during lectures and classroom exercises.
5. Learning skills
The student will have developed autonomous learning skills related to chromatographic, spectroscopic and spectrometric techniques through the consultation of databases, bibliographic material and scientific literature available online.

Educational objectives

General objectives
The Physical Methods in Organic Chemistry and Radiochemistry course aims to provide students with fundamental knowledge of modern chromatographic, spectroscopic and mass spectrometric techniques, commonly used in the study of organic molecules both in the research field and in control laboratories. The course also aims to provide the ability to identify the most suitable chromatographic techniques for solving real problems, and to understand UV, IR, MS and NMR spectra of organic molecules of biotechnological interest. Basic knowledge of nuclear chemistry, preparation and use of radiopharmaceuticals for diagnostic and therapeutic purposes are also provided. At the end of the course, students will acquire the skills to analyse NMR, IR and MS spectra, to derive the structure of unknown compounds from their combined analysis, and to predict the spectroscopic properties of new compounds.

Specific objectives
1. Knowledge and understanding
The student knows and understands the fundamentals of modern chromatographic techniques: adsorption, partition, thermodynamic aspects, van Deemter equation, composition and morphology of stationary phases, simple structure-retention relationships, solute-stationary phase-mobile phase interaction. The student knows the different elution modes in liquid chromatography (NP, RP, HILIC, PIC-LC, HIC). The student also knows and understands the fundamentals of spectroscopic techniques: matter-radiation interaction, the electromagnetic spectrum, wavelength, frequency, energy content, radiation intensity, absorption, emission, scattering, excited states, quantization. The student knows and understands the theoretical principles and practical applications of IR spectroscopies (harmonic oscillator, anharmonic oscillator, fundamental vibrations, overtone, combination bands, characteristic absorptions of the main functional groups), 1H-NMR and 13C-NMR (nuclei in a magnetic field, resonance, relaxation processes, screen and screen constants, homo- and hetero-nuclear spin-spin coupling, spin systems and Pople notation, Karplus relation). The student knows and understands the main ionization and fragmentation processes underlying the different mass spectrometry techniques; he/she knows the main ion sources and mass analysers suitable for the study of organic molecules and biological macromolecules. He/she is also able to interpret the mass spectrum of model compounds of pharmaceutical and biotechnological interest. The student knows and understands the theoretical principles and practical applications of coupled instrumental techniques (LC-MS), and can understand how the spectral parameters can be influenced by the experimental conditions (physical state of the sample, concentration, solvent, temperature). The student will also be able to determine the decays of unstable isotopes, and the type of radiation emitted, the main radiopharmaceuticals used in diagnostics and therapeutics in relation to the different districts of the organism.
2. Applying knowledge and understanding
The student is able to select the most suitable chromatographic technique based on the structure of the compounds to be analysed and is able to describe the process for the choice of stationary phases, mobile phases and detectors. He/she is able to control and optimize the kinetic and thermodynamic parameters of the chromatographic process and is able to apply the acquired knowledge to new problems typical of research contexts and in the workplace. The student is able to interpret IR, NMR, MS spectra of simple pure organic compounds, and is able to choose the spectroscopic technique or the combination of more techniques suitable for the different structural investigations (control of the conversion of functional groups, identification of impurities). The student is able to apply the known instrumental techniques to new problems that may arise in research or work contexts. At the end of the course the student will know the decay mechanisms and the radiation emitted by a radioelement and the main radiopharmaceuticals used in nuclear medicine, both in diagnostics and therapy.
3. Making judgement
The student is able to broaden and to extend the knowledge acquired during the Master's Degree course with skills relevant to the pharmaceutical aspects that characterize the Specialist Degree Course. The student will be able to independently select the proper analytical method for a specific analytical problem. He/she will also be able to acquire from databases and understand multispectral data useful for solving typical problems in research and production areas such as synthesis laboratories, quality control of active ingredients labs, laboratories of natural products analysis, as well as analysis of complex mixtures and metabolites. These skills are particularly stimulated and developed by carrying out spectral interpretation exercises during lectures and tutorials..
4. Communication
The student will be able to communicate what he/she has learned in a clear and rigorous manner, both to non-expert talkers and to experts in the field. The student is stimulated to interpersonal communication during lectures and classroom exercises.
5. Learning skills
The student will have developed autonomous learning skills related to chromatographic, spectroscopic and spectrometric techniques through the consultation of databases, bibliographic material and scientific literature available online.

Educational objectives

Module1 - Cellular and functional biochemistry I

Knowledge and ability to understand
Understanding of the biochemical and molecular mechanisms that regulate key cellular functions. Understanding of the molecular bases leading to alterations of cellular functions.

Ability to apply knowledge and understanding
At the end of the course the student will have acquired knowledge of the mechanisms that regulate the main cellular functions whose imbalance is the basis of the onset of pathologies. This knowledge will be useful for the rational design and development of new drugs.

Communication skills and learning skills
Students will be able to critically describe the molecular mechanisms that regulate the main cellular functions.

Module 2 - Cellular and functional biochemistry II

Knowledge and ability to understand
Knowledge of the systems responsible for the signaling pathways and of the transduction of intra- and extracellular signals, with particular attention to the function performed by the protein components and their mechanism of action.

Ability to apply knowledge and understanding
At the end of the course the student will have acquired knowledge of the main signaling pathways and of the transduction of intra- and extracellular signals useful for the rational design and development of new drugs.

Communication skills and learning skills
Students will be able to critically describe the main signaling and transduction pathways of cellular signals.

Educational objectives

Module 2 - Cellular and functional biochemistry II

Knowledge and ability to understand
Knowledge of the systems responsible for the signaling pathways and of the transduction of intra- and extracellular signals, with particular attention to the function performed by the protein components and their mechanism of action.

Ability to apply knowledge and understanding
At the end of the course the student will have acquired knowledge of the main signaling pathways and of the transduction of intra- and extracellular signals useful for the rational design and development of new drugs.

Communication skills and learning skills
Students will be able to critically describe the main signaling and transduction pathways of cellular signals.

Educational objectives

Module1 - Cellular and functional biochemistry I

Knowledge and ability to understand
Understanding of the biochemical and molecular mechanisms that regulate key cellular functions. Understanding of the molecular bases leading to alterations of cellular functions.

Ability to apply knowledge and understanding
At the end of the course the student will have acquired knowledge of the mechanisms that regulate the main cellular functions whose imbalance is the basis of the onset of pathologies. This knowledge will be useful for the rational design and development of new drugs.

Communication skills and learning skills
Students will be able to critically describe the molecular mechanisms that regulate the main cellular functions.

Educational objectives

General objectives
The general objective of the Human Physiology course is the understanding of physiological mechanisms in humans (explored at the cellular, organ, system and integrated physiology levels) aimed at the maintenance of body homeostasis. This knowledge is necessary for the student’s correct learning of the topics covered in following courses of the master’s degree, both theoretical and applied, in the pharmacological, physiopathological and biotechnological fields. This also ensures the student, at the end of the course, the correct overall vision required for pharmacological and/or biotechnological intervention on the human organism. Such an approach is further triggered along the course via specific references and links to both pharmacology and biotechnological applications proposed during the lectures.

Specific objectives
1. Knowledge and understanding of the student
During the course, the Pharmaceutical Biotechnology student will be provided with the tools for in-depth knowledge and complete understanding of the general, structural and functional organization of the human body, from the cellular to the system level, necessary and sufficient for the adequate training of the Pharmaceutical Biotechnology student in Human Physiology. The intra- and inter- cellular signalling and regulation mechanisms will be described in detail, together with their role in the integrative mechanisms between organs, apparatuses and systems, both in normal conditions and in response to alterations. For each of the body systems covered, references will be made to possible pathological conditions and related pharmacological or biotechnological interventions.
2. Ability to apply knowledge and understanding
At the end of the course, the student will have the knowledge necessary to fully understand the physiological interactions and integrations underlying the maintenance of homeostasis in the different conditions experienced by the human organism, both normal and altered. This will allow the student to critically integrate the understanding of Human Physiology with the knowledge of Pharmacology and Biotechnology during the future training and/or professional path. In the applied fields, the student will therefore be able to make use of the knowledge of human physiology in tasks such as, for example, the design of new generation drugs or drugs to be used in personalized or target-specific pharmacotherapy; or the development of therapeutic approaches based on biocompatible nanotechnologies.
3. Critical and judgment skills (lab tests, written reports, etc.)
Critical and judgment skills, as well as the effective understanding of the topics covered are verified during lectures by the Professor, whilst taking care of the homogenous proceeding of the entire students’ cohort in the critical understanding of Human Physiology. During the lectures, the proactive and interactive participation of the students are strongly encouraged and requested as well as the possibility of in-depth study of specific topics emerged during the classroom discussion. To this aim, the study of scientific articles to be agreed with the teacher will be assessed from time to time.
4. Ability to communicate what has been learned
The student is required to demonstrate a solid knowledge and critical understanding of each of the topics covered, from the molecular mechanisms underlying cellular and membrane physiology to the multi-systemic and integrated control of homeostatic parameters necessary for life. The student’s ability to communicate what has been learned is verified via oral exam during which the student demonstrates the knowledge acquired also through schematizations, descriptions of functions, equations, flow charts, both for Human Physiology and for the basics of Chemistry, Physics, Mathematics, Biology and Anatomy acquired by the students during the previous study career andfunctional to the understanding of Human Physiology.
5. Ability to continue studying independently
At the basis of the proper study of Human Physiology is both the use of the textbook (chosen according to the teacher’s instructions) and attendance to and active participation during the lectures - both of these are strongly recommended. Specific topics relevant to lectures matters and whose understanding may require in-depth teaching studying material will be clearly identified during the lecture and sufficient material will be made available to the students via the e-Learning platform. The critical spirit and cultural independence necessary in the background of the Pharmaceutical Biotechnologist will be widely stimulated during the lessons in order to generate the development of the personal tools necessary for the autonomous continuation of the study as well as of the professional activity.

Educational objectives

The course aims to provide the biochemical basis for understanding the development of technologies used in the research and production of proteins, enzymes and biomolecules useful for medicine, nutrition and industrial change.
During the course, the potential applications of biochemistry and biotechnology in the industrial field will be illustrated, with reference to the pharmaceutical industry.

Knowledge acquired
Understanding of the methodologies used for the development and production on an industrial scale of proteins and enzymes.
Knowledge of the general principles of protein engineering and advanced molecular biology techniques.
Knowledge of the application potential of protein biotechnology in industrial, diagnostic and therapeutic fields, with reference to the pharmaceutical industry.

Skills acquired
Ability to use molecular and biochemical techniques for the purification, analysis and use of enzymes and biomolecules.
Know how to design and produce recombinant proteins and their variants.
Evaluate and choose the best technical strategies for the specific use.

Communication and learning skills
Gain autonomy in the development of experimental protocols and the choice of molecular biology and biochemical techniques for the expression and production of recombinant proteins and enzymes.
Describe and critically relate the processes studied. Read scientific articles in the field of biochemistry-biotechnology and gain a critical understanding of their contents.

Educational objectives

Module 1 - Microbial biotechnology
General expected learning outcomes
The course is aimed at deepening microbiological knowledge and the main microbiological techniques useful for the preparation of new pharmaceutical formulations and the screening of molecules with potential antimicrobial activity. The course also aims to provide the skills necessary for the conception and design of scientific research aimed at the development of drugs and vaccines against human pathogens.

Specific objectives
1. Knowledge and understanding
At the end of the course, the student will acquire skills on the main infectious processes and the development of targeted antimicrobial strategies. Furthermore, the student will acquire specific skills to perform cytotoxicity tests, microbial counting, in order to test molecules with potential antimicrobial activity, using microbiology, biochemistry and molecular biology techniques.
2. Applying knowledge and understanding
At the end of the course, the student will acquire skills on the main microbiological, cellular and molecular biology techniques functional for the development of new potential drugs and vaccines with antimicrobial activity.
3. Making judgements
Lessons will be interactive. During the lessons the teacher will pursue an effective question strategy in order to stimulate the students’ ability to use a scientific methodological approach to research activities and study. The student will be stimulated to analyse experimental data related to course topics.
4. Communication
At the end of the course the student will be able to use an appropriate technical-scientific language to
communicate correctly on the topics covered, even with non-specialists or professionals from other disciplines.
5. Learning skills
The course is aimed at facilitating a critical and autonomous in-depth study of the topics covered in specialized texts and through consultation of databases and sector-specific platforms.

Module 2 - Pharmaceutical biotechnology
The course aims to provide a basis for understanding the scientific and technical development of innovative drugs and biotechnology pharmaceuticals. During the course will be illustrated the application potential with particular reference to the pharmaceutical industry and the fundamental aspects inherent in the production processes on a laboratory scale and on an industrial scale of biotechnological drugs.

Acquired knowledge
Competence in the field of pharmaceutical biotechnologies in order to design, develop, test, formulate and produce new biotech compounds.

Acquired competences
Conceptual and technical bases of innovative biotechnology methodologies applied to the process of development and production of biopharmaceuticals.

Communication and learning skills
Describe and critically relate the processes studied. Read scientific articles in the field of biopharmaceuticals, read and analyze the regulations applied to the biopharmaceutical production with a critical analysis of their contents.

Educational objectives

Module 2 - Pharmaceutical biotechnology
The course aims to provide a basis for understanding the scientific and technical development of innovative drugs and biotechnology pharmaceuticals. During the course will be illustrated the application potential with particular reference to the pharmaceutical industry and the fundamental aspects inherent in the production processes on a laboratory scale and on an industrial scale of biotechnological drugs.

Acquired knowledge
Competence in the field of pharmaceutical biotechnologies in order to design, develop, test, formulate and produce new biotech compounds.

Acquired competences
Conceptual and technical bases of innovative biotechnology methodologies applied to the process of development and production of biopharmaceuticals.

Communication and learning skills
Describe and critically relate the processes studied. Read scientific articles in the field of biopharmaceuticals, read and analyze the regulations applied to the biopharmaceutical production with a critical analysis of their contents.

Educational objectives

Module 1 - Microbial biotechnology
General expected learning outcomes
The course is aimed at deepening microbiological knowledge and the main microbiological techniques useful for the preparation of new pharmaceutical formulations and the screening of molecules with potential antimicrobial activity. The course also aims to provide the skills necessary for the conception and design of scientific research aimed at the development of drugs and vaccines against human pathogens.

Specific objectives
1. Knowledge and understanding
At the end of the course, the student will acquire skills on the main infectious processes and the development of targeted antimicrobial strategies. Furthermore, the student will acquire specific skills to perform cytotoxicity tests, microbial counting, in order to test molecules with potential antimicrobial activity, using microbiology, biochemistry and molecular biology techniques.
2. Applying knowledge and understanding
At the end of the course, the student will acquire skills on the main microbiological, cellular and molecular biology techniques functional for the development of new potential drugs and vaccines with antimicrobial activity.
3. Making judgements
Lessons will be interactive. During the lessons the teacher will pursue an effective question strategy in order to stimulate the students’ ability to use a scientific methodological approach to research activities and study. The student will be stimulated to analyse experimental data related to course topics.
4. Communication
At the end of the course the student will be able to use an appropriate technical-scientific language to
communicate correctly on the topics covered, even with non-specialists or professionals from other disciplines.
5. Learning skills
The course is aimed at facilitating a critical and autonomous in-depth study of the topics covered in specialized texts and through consultation of databases and sector-specific platforms.

Educational objectives

The teaching consists of two modules: "Structural Biology" and "Structural Bioinformatics", each with 3 CFU, for a total of 6 CFU. The training objectives were defined to provide students with a thorough and integrated knowledge of biological structures and bioinformatics tools used to analyse them, with particular emphasis on pharmaceutical applications.
General objectives of the course:
Interdisciplinary Competence: Contribute to the training of professionals who are able to integrate knowledge of biology and structural bioinformatics and apply this integrated knowledge in research and development of new drugs.
Analytical and Critical Skills: Develop the ability to critically analyze molecular structures and biological interactions through experimental and computational approaches.
This course aims, within the context of the entire Pharmaceutical Biotechnology course, to provide the specific knowledge needed to prepare students for the scientific and technological challenges in the field of pharmaceutical biotechnology, providing them with the tools they need to contribute effectively to research and development of new therapies.

Specific objectives:

Module 1: Structural Biology (3 ECTS)
1. Understanding the Structural Bases of Biological Macromolecules:
• To know the structure and function of the main biological macromolecules (in particular proteins and nucleic acids).
• Explore the molecular interactions and structural dynamics that affect biological function.
2. Structural Determination Techniques:
• Understand the basics of major techniques used to determine macromolecular structure, including X-ray crystallography, nuclear magnetic resonance (NMR) and electron microscopy (EM).
• Understand the theoretical principles behind these techniques and how they are applied in structural research.
3. Applications in Pharmaceutical Biotechnology:
• Analyze how knowledge of molecular structures can be used for drug development.
• Examine case studies that illustrate the role of structural biology in the discovery and development of innovative drugs.

Educational objectives

The teaching consists of two modules: "Structural Biology" and "Structural Bioinformatics", each with 3 CFU, for a total of 6 CFU. The training objectives were defined to provide students with a thorough and integrated knowledge of biological structures and bioinformatics tools used to analyse them, with particular emphasis on pharmaceutical applications.
General objectives of the course:
Interdisciplinary Competence: Contribute to the training of professionals who are able to integrate knowledge of biology and structural bioinformatics and apply this integrated knowledge in research and development of new drugs.
Analytical and Critical Skills: Develop the ability to critically analyze molecular structures and biological interactions through experimental and computational approaches.
This course aims, within the context of the entire Pharmaceutical Biotechnology course, to provide the specific knowledge needed to prepare students for the scientific and technological challenges in the field of pharmaceutical biotechnology, providing them with the tools they need to contribute effectively to research and development of new therapies.

Specific objectives:

Module 1: Structural Biology (3 ECTS)
1. Understanding the Structural Bases of Biological Macromolecules:
• To know the structure and function of the main biological macromolecules (in particular proteins and nucleic acids).
• Explore the molecular interactions and structural dynamics that affect biological function.
2. Structural Determination Techniques:
• Understand the basics of major techniques used to determine macromolecular structure, including X-ray crystallography, nuclear magnetic resonance (NMR) and electron microscopy (EM).
• Understand the theoretical principles behind these techniques and how they are applied in structural research.
3. Applications in Pharmaceutical Biotechnology:
• Analyze how knowledge of molecular structures can be used for drug development.
• Examine case studies that illustrate the role of structural biology in the discovery and development of innovative drugs.

Educational objectives

The teaching consists of two modules: "Structural Biology" and "Structural Bioinformatics", each with 3 CFU, for a total of 6 CFU. The training objectives were defined to provide students with a thorough and integrated knowledge of biological structures and bioinformatics tools used to analyse them, with particular emphasis on pharmaceutical applications.
General objectives of the course:
Interdisciplinary Competence: Contribute to the training of professionals who are able to integrate knowledge of biology and structural bioinformatics and apply this integrated knowledge in research and development of new drugs.
Analytical and Critical Skills: Develop the ability to critically analyze molecular structures and biological interactions through experimental and computational approaches.
This course aims, within the context of the entire Pharmaceutical Biotechnology course, to provide the specific knowledge needed to prepare students for the scientific and technological challenges in the field of pharmaceutical biotechnology, providing them with the tools they need to contribute effectively to research and development of new therapies.

Specific objectives:

Module 2: Structural Bioinformatics (3 ECTS)
Preliminary: understanding the biological and evolutionary context as a prerequisite for bioinformatic analyses
1. Bioinformatics tools and techniques for structural analysis:
• Knowledge and use of the main bioinformatics databases
• Understand and apply the main tools for sequence alignment and database search and be able to critically interpret results
• Understand and apply the main tools of prediction and analysis of sequence-based three-dimensional structures including hints to machine learning and its applications in bioinformatics
• Know how to use the basic functions of integrated sequence and structure analysis tools
2. Molecular Modelling and Simulations:
• Know how to use the basic functions of the main tools for molecular graphics and structural analysis: ChimeraX or PyMOL
• Learn the theoretical basis of molecular modelling, including structural prediction through homology and de novo and use of related resources.
• Understand the basic concepts of molecular dynamics
3. Computational analysis and data interpretation:
• Develop skills in structural data analysis using computational methods.
• Understand the limits of techniques and fields of application
• Interpret the results of bioinformatic analyses and integrate this information to apply it to biotechnology and pharmaceutical problems.

Educational objectives

General objectives
The basic objective of the course is to enable the graduate in Pharmaceutical Biotechnology to achieve a high qualification in the field of pharmacology, which is essential for his or her entry into the world of work, in the fields of design and development of innovative biopharmaceuticals and the study of their cellular and molecular mechanisms.

Specific objectives
The lectures will aim to provide basic pharmacological knowledge on the main classes of drugs used in clinical therapy, including biotechnological drugs and innovative therapies already available. Particular attention will be given to the cellular and molecular mechanisms by which they produce therapeutic effects and the rationale behind the development of new drugs, where current therapies are not yet optimal, particularly in terms of efficacy or safety. Particular attention will be given to recent scientific literature concerning the identification of new therapeutic targets and the design of innovative biotechnological drugs.
The course will also provide basic knowledge on in vitro and in vivo experimental models most commonly used for the development of new drugs, as well as on approaches that allow the analysis and evaluation of experimental results. The course aims, in fact, to train future pharmaceutical biotechnologists able to face, with critical skills and judgment, the problems related to the screening of new drugs, especially biotechnological and/ or biological drugs, in relation to existing drugs.
Among the skills that will be acquired by the student at the end of the course there is also the ability to communicate what has been learned, which will be continuously stimulated through a timely and constant interaction with the teacher in the classroom, during the course. In particular, the student will be called to participate actively in the lesson through various modes of interaction with the teacher or colleagues, with the aim of recalling or linking what was discussed in the lesson to topics already covered, in this course or in the other courses of the cycle. Finally, through reference to scientific databases (e.g. Pubmed) or websites of public or private organizations in the field (e.g. AIFA, ISS, Società Italiana di Farmacologia), the course will train the student to use these useful sources in order to continue the continuous updating independently during his professional career.

Expected learning outcomes
At the end of the course, the student will have acquired in-depth knowledge about the biotechnological drugs already in use and will be able to apply them for the identification of new targets and the consequent design and study of innovative drugs.
The student will also have acquired the skills to evaluate not only the design of a preclinical study but also that of a clinical trial for the development of innovative drugs and/ or biotechnology, with particular attention to the analysis of primary and secondary endpoints.

Educational objectives

General Aims
The objective of the course of Molecular and Cellular Pathology is to provide a firm foundation for understanding the molecular and cellular basis of disease. Goals: understanding the molecular complexity in human disease basis, understanding how most common diseases are linked to the dysfunction of specific pathways and how the application of molecular and cellular approach might help to advance medical research and the translation and application of knowledge to human disease.

Specific Aims
1. Knowledge and Understanding
The goal of the courses is to provide students with a rigorous intellectual foundation of the cellular and molecular pathogenesis of human disease. Appreciate how most human diseases are linked with molecular or cellular dysfunction. Students should be able to articulate basic disease mechanisms that can underlie an identified pathology.
2. Applying Knowledge and Understanding
At the end of the course students will have a solid understanding of the basic mechanisms at the cellular and molecular level that are correlated with the pathologic mechanisms that underlie human disease. This background is particularly important for Pharmaceutical Biotechnolgy students by equipping students with an advanced knowledge of molecular pathology and an understanding of the relevant principles and rationale for practical applications of therapeutic approach.
3. Making judgments
Didactic and highly interactive lectures are provided to obtain an understanding of how in most common diseases insufficient knowledge about the pathogenesis of human diseases may limit the effectiveness of the present therapeutic approaches. Students will know how molecular and cellular pathology is presently applied to gain insight into how disease conditions are investigated at a molecular level, as well as understanding how this may positively affect the therapeutic approach to human diseases.
4. Communication skills
Students' achievement of learning outcomes is demonstrated by the ability to analyze and critically discuss molecular and cellular mechanisms that contribute to human disease. Students’ evaluation is based on an oral exam and the final score represents the sum of the two modules of the course. The overall knowledge of students is verified, and students obtain their evaluation from grade 18 to grade 30. An exam is considered passed if the final grade is equal to or higher than 18/30. In the event of a full grade (30/30), the Examination Board may grant honours (lode).
5. Learning skills
The Program in Molecular and cellular pathology focuses on the molecular mechanisms that cause diseases, the newest technologies in genomics, and proteomics as well as the development of prognostic, diagnostic and therapeutic tools. This is a crucial aspect to help students understand their learning interests as Pharmacological Biotechnology students, enhancing their dispositions to be active and autonomous learners.

Educational objectives

The course is aimed at providing the students with conceptual basis and technical knowledge to design new chemical entities. In particular, during the course the students will develop computational skill in physical-chemistry theory of medicinal chemistry. Methods in both ligand-based drug design (no knowledge of target) and structure-based drug design (known structure of the target) will be learned both in theoretical aspects and in detailed practical sessions. Practical sessions will also introduce the students to the use of personal computers.

Acquired knowledges
Make structure-activity relationships for a given series of bioactive compounds and rationalization of their quantitative and structural features to design new molecular entities of pharmaceutical interest.

Acquired competences
Set up a rational approach for the rational design of new derivatives through LBDD and SBDD software techniques.

Educational objectives

Module 1 - PHARMACOTOXICOLOGY OF BIOLOGICAL MEDICINAL PRODUCTS

General objectives
Provide the student the basic scientific and regulatory knowledge and formation that will allow him/her to find, analyse and critically assess the data and documentation about biological drugs. During classes, actual examples of existing biologic drugs will be discusses. This will allow the student to apply the acquired knowledge and practice with the critical data evaluation. In the preparation of the final test, consisting in the oral presentation (with visual support) and critical assessment of a biologic drug, dialoguing with the teacher and other students will stimulate and refine the communication skills.

Specific objectives
1. Knowledge and understanding
Knowledge of main biologic drugs and their peculiar pharmacodynamics features. Comprehension of the non-clinical and clinical development of a new drug. Knowledge of pharmacokinetics and methods of pharmacokinetic analysis. Comprehension of basic toxicology and the methods used for biologic and small molecule drugs. Knowledge of pharmacovigilance and its methods
2. Applying knowledge and understanding
At the end of the course, the student should be able to: 1) find and critically evaluate scientific data about biological drugs and herbal drugs, also taking into account the current regulations; 2) participate to plan, carry out and assess the development plan of a new biologic drug
3. Making judgements
The student should be able to evaluate the benefit/risk profile of single drugs. He/she should also be able to highlight the critical points of the drugs, with regard to efficacy and safety. The student should be able to assess the efficacy of the measure implemented with the aim of improving the risk/benefit profile, in connection with regulatory requirements.
4. Communication skills
The student should be able to communicate exhaustively and concisely the information about a given drug, highlighting efficaciously the critical issues.
5. Learning skills
The course aims to provide the formation giving the student the ability of evaluating critically the sources of information widely available, particularly in the web. During the course, the teacher will illustrate the main sources of reliable information, such as databases and sites of institutional organizations.

Module 2 - PHARMACOGNOSTIC BIOTECHNOLOGY

General objectives
The course aims to provide students with a basic understanding of medicinal plants and herbal drugs, with particular focus on their phytochemical composition, the pharmacological and toxicological properties of the main natural constituents, and their applications in the pharmaceutical, cosmetic, and nutraceutical fields. In line with the biotechnological orientation of the degree program, the course emphasizes the role of biotechnology in enhancing the therapeutic and industrial potential of plant-derived materials. In particular, it introduces innovative technologies aimed at the sustainable and standardized production of bioactive compounds, as well as the qualitative improvement of herbal drugs.

Specific objectives
1. Knowledge and understanding
Students will acquire knowledge of herbal drugs, with reference to their phytochemical
composition, pharmacological and toxicological effects, and their uses in the pharmaceutical,
cosmetic, and nutraceutical sectors. They will also deepen their understanding of issues related to
the quality, safety, and variability of plant-based preparations. In addition, they will learn the basic concepts of regulations governing the production and marketing of plant-based products.
2. Applying knowledge and understanding
Students will be able to recognize the main herbal drugs and understand their pharmacological
and toxicological profiles. Furthermore, they will be able to apply biotechnological strategies, such
as micropropagation, callus culture, and plant molecular farming, to improve the quality and
consistency of herbal drugs and to support the production of standardized and reproducible
phytocomplexes and bioactive compounds of pharmaceutical interest.
3. Making judgements
Through the critical analysis of case studies and scientific literature, students will develop the
ability to assess the quality of plant materials, evaluate risks associated with their use, and
understand the potential impact of innovative technologies on the development of new plant-based products.
4. Communication skills
Students will be able to use appropriate technical and scientific language and to communicate
clearly and effectively the concepts related to pharmacognosy, phytochemistry, phytotherapy and
plant biotechnologies in professional, academic, and multidisciplinary contexts.
5. Learning skills
The course will promote the development of autonomous learning and a lifelong learning attitude,
providing students with theoretical and methodological tools to independently explore the
applications of biotechnologies in the field of medicinal plants and natural products.
 

Educational objectives

Module 2 - PHARMACOGNOSTIC BIOTECHNOLOGY

General objectives
The course aims to provide students with a basic understanding of medicinal plants and herbal drugs, with particular focus on their phytochemical composition, the pharmacological and toxicological properties of the main natural constituents, and their applications in the pharmaceutical, cosmetic, and nutraceutical fields. In line with the biotechnological orientation of the degree program, the course emphasizes the role of biotechnology in enhancing the therapeutic and industrial potential of plant-derived materials. In particular, it introduces innovative technologies aimed at the sustainable and standardized production of bioactive compounds, as well as the qualitative improvement of herbal drugs.

Specific objectives
1. Knowledge and understanding
Students will acquire knowledge of herbal drugs, with reference to their phytochemical
composition, pharmacological and toxicological effects, and their uses in the pharmaceutical,
cosmetic, and nutraceutical sectors. They will also deepen their understanding of issues related to
the quality, safety, and variability of plant-based preparations. In addition, they will learn the basic concepts of regulations governing the production and marketing of plant-based products.
2. Applying knowledge and understanding
Students will be able to recognize the main herbal drugs and understand their pharmacological
and toxicological profiles. Furthermore, they will be able to apply biotechnological strategies, such
as micropropagation, callus culture, and plant molecular farming, to improve the quality and
consistency of herbal drugs and to support the production of standardized and reproducible
phytocomplexes and bioactive compounds of pharmaceutical interest.
3. Making judgements
Through the critical analysis of case studies and scientific literature, students will develop the
ability to assess the quality of plant materials, evaluate risks associated with their use, and
understand the potential impact of innovative technologies on the development of new plant-based products.
4. Communication skills
Students will be able to use appropriate technical and scientific language and to communicate
clearly and effectively the concepts related to pharmacognosy, phytochemistry, phytotherapy and
plant biotechnologies in professional, academic, and multidisciplinary contexts.
5. Learning skills
The course will promote the development of autonomous learning and a lifelong learning attitude,
providing students with theoretical and methodological tools to independently explore the
applications of biotechnologies in the field of medicinal plants and natural products.
 

Educational objectives

Module 1 - PHARMACOTOXICOLOGY OF BIOLOGICAL MEDICINAL PRODUCTS

General objectives
Provide the student the basic scientific and regulatory knowledge and formation that will allow him/her to find, analyse and critically assess the data and documentation about biological drugs. During classes, actual examples of existing biologic drugs will be discusses. This will allow the student to apply the acquired knowledge and practice with the critical data evaluation. In the preparation of the final test, consisting in the oral presentation (with visual support) and critical assessment of a biologic drug, dialoguing with the teacher and other students will stimulate and refine the communication skills.

Specific objectives
1. Knowledge and understanding
Knowledge of main biologic drugs and their peculiar pharmacodynamics features. Comprehension of the non-clinical and clinical development of a new drug. Knowledge of pharmacokinetics and methods of pharmacokinetic analysis. Comprehension of basic toxicology and the methods used for biologic and small molecule drugs. Knowledge of pharmacovigilance and its methods
2. Applying knowledge and understanding
At the end of the course, the student should be able to: 1) find and critically evaluate scientific data about biological drugs and herbal drugs, also taking into account the current regulations; 2) participate to plan, carry out and assess the development plan of a new biologic drug
3. Making judgements
The student should be able to evaluate the benefit/risk profile of single drugs. He/she should also be able to highlight the critical points of the drugs, with regard to efficacy and safety. The student should be able to assess the efficacy of the measure implemented with the aim of improving the risk/benefit profile, in connection with regulatory requirements.
4. Communication skills
The student should be able to communicate exhaustively and concisely the information about a given drug, highlighting efficaciously the critical issues.
5. Learning skills
The course aims to provide the formation giving the student the ability of evaluating critically the sources of information widely available, particularly in the web. During the course, the teacher will illustrate the main sources of reliable information, such as databases and sites of institutional organizations.

Educational objectives

The course aims to provide the student with basics in formulation of biotechnological drugs, as well as development of conventional and innovative pharmaceutical dosage forms. To this end, the course aims to give adequate theoretical bases in order to make the student able to comprehend the relation between the properties of the different dosage forms and their biopharmaceutical and pharmacokinetic fate in vivo, considering the physico-chemical properties of the drug as well as the therapeutic objective. At the same time, the course aims to provide deep knowledge on different formulation strategies and analytical techniques to characterize the different pharmaceutical forms.
The course further aims to provide the student with knowledge about manufacturing, patenting,
registration, and commercialization of biotechnological drugs. Overall, the course aims to develop
knowledge about the main formulation, manufacturing, quality and regulatory issues.

At the end of the course, the student should demonstrate:
1) Knowledge and understanding skills on the following topics:
- basics on formulation, manufacturing and quality control of the principal conventional and innovative dosage forms
- technological characteristics of the excipients.
- theoretical bases of controlled release of drugs.
- pharmaceutical legislation and regulation with focus on biotechnological drugs.
2) Applying knowledge and understanding
The course aims to provide the student with general principles to optimize the efficacy of biotechnological drugs, taking into consideration the physico-chemical and stability properties of the active molecule as well as the administration route, the delivery vehicle and the targeting strategy more suitable to achieve the desired therapeutic effect. Therefore, the student will be able to follow the steps of the manufacturing process of medicines and to prepare the principal conventional and innovative dosage forms, taking into account potential formulation, regulatory and safety issues.
3) Making judgements
At the end of the course, the student will have to take a written exam on the regulatory part and an oral
exam on the technological part, to demonstrate the ability to evaluate technological, regulatory and safety issues related to the manufacturing of a conventional or innovative dosage form.
4) Communication skills
During the course, some roundtables sessions will be carried forward under the direction of the professor to evaluate the communication skills of the student. Communication skills will also be assessed through innovative teaching methods such as flipped classrooms. These sessions will be important to develop the ability to critically evaluate technological, regulatory and safety issues related to the manufacturing of conventional or innovative dosage forms. They will also be useful to develop the ability to properly report this information to both expert and inexpert people.
5) Lifelong learning skills
The course will provide the student with theoretical basis and tools to develop independent lifelong
learning skills, in order to to further enrich knowledge, thus maintaining it on a constant level. This point is particularly important considering the quick and incessant evolution of pharmaceutical technologies and legislation.

Educational objectives

In addition to the curricular courses, students have at their disposal 9 CFU for autonomously chosen training activities that include courses (at least one with an examination) present within the educational offer of Sapienza University, as long as they are consistent with the training project, which can be used to complete one’s preparation.
To verify that the choices are consistent with the training objectives of the course, the student must fill out his or her training path through the Infostud portal, indicating the lessons with which to acquire the 9 CFU corresponding to the independently chosen activities. This request is sent to the course chair (or a reference contact) for evaluation. In the case of courses selected from a list of recommended examinations and reported both during the compilation of the training course, or on the website of the bachelor’s degree in Pharmaceutical Biotechnology, the application will be directly authorized. In the case of lessons not included in the list of recommended exams, the request will be evaluated by the Course Council to verify the consistency of the choices made and possibly provide alternative lessons or activities. It is possible to indicate courses leading to the acquisition of up to 12 CFU compared with 9 required.
The student can include in the activities of free choice that has available a type of internship/ internship that he has not selected as mandatory.

Educational objectives

The final exam consists of writing, presenting and discussing a written thesis which is independently elaborated by the student on the basis of his own research activity conducted under the supervision of the thesis rapporteur. The thesis documents in detail the project developed and the individual experimental activity carried out and has the function of strengthening the critical and methodological autonomy of the student to promote a profitable insertion into the workplace.