Formulation and Legislation of Monoclonal Antibodies, Nanovectors, and Advanced Therapy Medicinal Products
A.Y. 2025/2026
Learning objectives
The purpose of this course is that students gain knowledge on the critical aspects related to
- biopharmaceutics of parenteral dosage forms;
- formulation of monoclonal antibodies and drugs loaded nanovectors, with particular emphasis to lipid based nanosystems;
- regulation of manufacturing and processes to grant the marketing authorization of medicinal products.
- biopharmaceutics of parenteral dosage forms;
- formulation of monoclonal antibodies and drugs loaded nanovectors, with particular emphasis to lipid based nanosystems;
- regulation of manufacturing and processes to grant the marketing authorization of medicinal products.
Expected learning outcomes
At the end of the course, students are expected to know:
- the basic information on dispersed systems and their physical stabilization;
- the key critical attributes of parenteral dosage forms: sterility, isotonicity, isohydria and endotoxins;
- main methods of preparation and drug loading of nanovectors;
- absorption and distribution of monoclonal antibodies and drug loaded nanovectors administered by the different parenteral routes of administration;
- to outline the steps required to place a medicinal product on the market, with a focus on complex drugs and advanced therapy medicinal products. They are expected to be able to retrieve and understand the relevant parts of EU legislative acts.
- acquisition of communication skills
- the basic information on dispersed systems and their physical stabilization;
- the key critical attributes of parenteral dosage forms: sterility, isotonicity, isohydria and endotoxins;
- main methods of preparation and drug loading of nanovectors;
- absorption and distribution of monoclonal antibodies and drug loaded nanovectors administered by the different parenteral routes of administration;
- to outline the steps required to place a medicinal product on the market, with a focus on complex drugs and advanced therapy medicinal products. They are expected to be able to retrieve and understand the relevant parts of EU legislative acts.
- acquisition of communication skills
Lesson period: First semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
Course syllabus and organization
Single session
Responsible
Lesson period
First semester
Course syllabus
The formulation section will cover the following topics:
-Biopharmaceutics and routes of administration
-Requirements for parenteral dosage forms
-Water for pharmaceutical use
-Sterilization
-Lyophilization (freeze-drying)
-Interfacial phenomena and dispersed systems
-Colloids
-Suspensions
-Emulsions
-Modified-release pharmaceutical dosage forms
-Nanotechnologies: introduction, use in drug delivery, biodistribution of nanocarriers
-Characterization, preparation, and main features of the most commonly used nanocarriers for drug delivery—such as micelles, liposomes, polymeric nanoparticles, and solid lipid nanoparticles
-Nanocarriers for nucleic acid delivery
-Methods for stabilizing nanoparticle dispersions
-Finished product quality controls and stability
The teaching part on "Regulatory aspects" focuses on the regulatory issues related to the manufacturing and marketing of medicinal products.
-EU law-making bodies and the European Medicines Agency (EMA). EU Pharmaceutical Law: aims and scope of Directive 2001/83/CE and Regulation (EU) No. 726/2004
-Definition of medicinal product: its rationale and how it is meant to protect citizens' health (ref. Directive 2001/83/CE) + borderline
-The Manufacturing Authorisation of medicinal products: when it is necessary, how it is obtained (ref. Directive 2001/83/CE). Good Manufacturing Practice (GMP).
-The Marketing Authorisation (MA) of medicinal products. The 4 procedures for applying for a MA (ref. Directive 2001/83/CE and Regulation CE no. 726/2004).
-The dossier in a MA application and the Common Technical Document (CTD). Full, partial, simplified dossiers (ref. Directive 2001/83/CE). + nanosimilars
-Advanced Therapy Medicinal Products (ATMPs): regulatory aspects.
Conditional MA and Authorisation in exceptional circumstances.
-Orphan medicinal products.
-Summary of Product's Characteristics, Labelling and Package Leaflet of medicinal products. European Public Assessment Reports (EPARs)
-Biopharmaceutics and routes of administration
-Requirements for parenteral dosage forms
-Water for pharmaceutical use
-Sterilization
-Lyophilization (freeze-drying)
-Interfacial phenomena and dispersed systems
-Colloids
-Suspensions
-Emulsions
-Modified-release pharmaceutical dosage forms
-Nanotechnologies: introduction, use in drug delivery, biodistribution of nanocarriers
-Characterization, preparation, and main features of the most commonly used nanocarriers for drug delivery—such as micelles, liposomes, polymeric nanoparticles, and solid lipid nanoparticles
-Nanocarriers for nucleic acid delivery
-Methods for stabilizing nanoparticle dispersions
-Finished product quality controls and stability
The teaching part on "Regulatory aspects" focuses on the regulatory issues related to the manufacturing and marketing of medicinal products.
-EU law-making bodies and the European Medicines Agency (EMA). EU Pharmaceutical Law: aims and scope of Directive 2001/83/CE and Regulation (EU) No. 726/2004
-Definition of medicinal product: its rationale and how it is meant to protect citizens' health (ref. Directive 2001/83/CE) + borderline
-The Manufacturing Authorisation of medicinal products: when it is necessary, how it is obtained (ref. Directive 2001/83/CE). Good Manufacturing Practice (GMP).
-The Marketing Authorisation (MA) of medicinal products. The 4 procedures for applying for a MA (ref. Directive 2001/83/CE and Regulation CE no. 726/2004).
-The dossier in a MA application and the Common Technical Document (CTD). Full, partial, simplified dossiers (ref. Directive 2001/83/CE). + nanosimilars
-Advanced Therapy Medicinal Products (ATMPs): regulatory aspects.
Conditional MA and Authorisation in exceptional circumstances.
-Orphan medicinal products.
-Summary of Product's Characteristics, Labelling and Package Leaflet of medicinal products. European Public Assessment Reports (EPARs)
Prerequisites for admission
Students are required to be familiar with the basic concepts of physics, inorganic and organic chemistry, as well as general knowledge on physiology. These topics are generally provided within courses at the Bachelor Degree.
Teaching methods
Attendance at lessons is recommended; during the lessons, different tasks (e.g., group projects and case studies) may be assigned to individual students or student groups to support understanding of the core topics.
Teaching Resources
The course materials will be available on the my ARIEL site.
Additionally, the following reference texts are available in University libraries and in online format.
-Tecnologia farmaceutica 2025/ a cura di Paolo Caliceti
-Aulton's Pharmaceutics, The Design and Manufacture of Medicines - Edited by Michael E. Aulton and Kevin M.G. Taylor
-Pharmaceutical Biotechnology available at https://link.springer.com/book/10.1007/978-3-030-00710-2 (after loggin in at UNIMI online library)
-Relevant guidelines for the Regulatory aspects are listed on the ARIEL website (in the 'Course information' section).
-Shorthose S (Ed.). Guide to EU pharmaceutical regulatory law, seventh edition (2017). Kluwer Law International. Available for free on UNIMI's digital Library, direct link: https://unimi.primo.exlibrisgroup.com/discovery/fulldisplay?docid=alma991017345717906031&context=L&vid=39UMI_INST:VU1&lang=it&search_scope=MyInst_and_CI&adaptor=Local%20Searc%20h%20Engine&tab=Everything&query=any,contains,pharmaceutical%20law
Additionally, the following reference texts are available in University libraries and in online format.
-Tecnologia farmaceutica 2025/ a cura di Paolo Caliceti
-Aulton's Pharmaceutics, The Design and Manufacture of Medicines - Edited by Michael E. Aulton and Kevin M.G. Taylor
-Pharmaceutical Biotechnology available at https://link.springer.com/book/10.1007/978-3-030-00710-2 (after loggin in at UNIMI online library)
-Relevant guidelines for the Regulatory aspects are listed on the ARIEL website (in the 'Course information' section).
-Shorthose S (Ed.). Guide to EU pharmaceutical regulatory law, seventh edition (2017). Kluwer Law International. Available for free on UNIMI's digital Library, direct link: https://unimi.primo.exlibrisgroup.com/discovery/fulldisplay?docid=alma991017345717906031&context=L&vid=39UMI_INST:VU1&lang=it&search_scope=MyInst_and_CI&adaptor=Local%20Searc%20h%20Engine&tab=Everything&query=any,contains,pharmaceutical%20law
Assessment methods and Criteria
The exam will consist of an oral assessment covering all aspects addressed during the lessons. Students will be required to demonstrate the ability to make connections between the various topics.
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 7
Lessons: 56 hours
Professors:
Franze' Silvia, Musazzi Umberto Maria
Professor(s)