510539 - ANALYTICAL METHODS FOR NANOBIOPHARMACEUTICALS

courses

ID:

510539

Duration (hours):

24

CFU:

SSD:

CHIMICA FARMACEUTICA

Year:

2025

Date/time interval

Primo Semestre (29/09/2025 - 23/01/2026)

Course Objectives

The aim of this module is to provide knowledge on the identification and reliable quantification of some critical quality attributes (CQAs) of biotechnological drug-loaded nanoparticles using routine and emerging analytical characterization techniques. At the and of the module the student will be trained on the application of analytical instrumental techniques for the determination of the loading, purity, stability and release of the API from a formulated nanocarrier. Students will also learn how to put in context this knowledge in an industrial environment, where the analysis of drugs is regulated by specific Guidelines. As a result, in the last part of the module, students will be able to critically read and discuss, in class, research articles (case studies) related to the contents acquired.

Course Prerequisites

To follow the course profitably it is useful for the student to have acquired basic knowledge of analytical chemistry, spectroscopy and liquid chromatography (HPLC). Students who do not have this knowledge are expected to have attended the “Analytical Chemistry” module (1st year module).

Teaching Methods

Teaching methods include lectures in class, discussion in class of the lecture topics, reading and discussion in class of research papers.
For students with specific needs, who cannot attend teaching activities in person and who have applied for Inclusive Teaching Methods, teaching material suitable for profitable independent study will be available. If requested, self-learning can be supported by tutoring activities of supplementary teaching, and by dedicated meetings, also online, with flexible hours depending on needs.

Assessment Methods

Oral exam. The student will have to demonstrate to have acquired knowledge on theory and application of analytical instrumental techniques for the determination of the loading, purity, stability and release of the API from a formulated nanocarrier, also in the context of industrial quality control (analytical method validation, specifications, stability). Evaluation criteria: completeness of contents, reasoning ability, ability to connect topics, appropriateness of scientific language, contextualization of topics with respect to industrial application. Before taking the exam for this module, it is strongly recommended that you first take the exam of Industrialization and Regulatory aspects. Otherwise, the partial assessment for Analytical Methods for Nanobiopharmaceuticals will be valid for 6 exam sessions, after which the student will be required to retake both modules. Appropriate examination methods are foreseen for students who fall into the categories foreseen for Specific Learning Disorders (DSA) and Special Educational Needs (BES).

Texts

*UPLC: 1) Eric S. Grumbach; Joseph C. Arsenault; Douglas R. McCabe: Beginners Guide to UPLC: Ultra-Performance Liquid Chromatography, 1st Ed., Waters Corporation, 2009; 2) Michael W Dong: HPLC and UHPLC for practicing Scientists, 2nd Ed., Wiley, 2019.
*CE: 1) Agilent Technologies, High performance Capillary Electrophoresis, an introduction. 2) Ahuja, S. Jimidar MI: Capillary electrophoresis methods for pharmaceutical analysis , Academic Press; 2008.
* HPLC: Kazakevich, Lobrutto, HPLC for Pharmaceutical Scientists, Wiley;
*ICH Topics covered by the programme to be found at EMA site: https://www.ema.europa.eu/en
*Selected research papers will be passed out by the lecturer to the students for discussion in class of case studies
* Many other scientific papers will be suggested for a deeper insight (on a voluntary basis)

1. Also to underline the importance of orthogonal techniques for the identification and measurement of CQAs in the case of drug products containing nanomaterials, the first part of this module will focus on advanced HPLC, chiral HPLC, supercritical fluid chromatography, micro and nano LC, UPLC, Capillary Electrophoresis;
2. Nanomaterial sample pretreatment;
3. To ensure quality, safety and efficacy of the final nanobiopharmaceutical product and also to monitor CQAs throughout the manufacturing process, the second part of the module will include: International Council on Harmonisation (ICH) guidelines for the Validation of analytical Procedures, for Specifications, for Stability testing. Concepts of Analytical Quality by Design (AqbD).
4. The module will conclude with reading and discussion in class of case studies (research papers) related to characterization of nanobiopharmaceuticals by at least one of the analytical tecniques presented during the course.

Course Language

English

More information

Slides will be made available to attending students before each lecture. The list of attending students will be made at the beginning of the module lectures (1st lecture day). Details on the module organisation (slides availability, communication to/from students, office hours, module organisation) will be given in class at the beginning of the module (1st lecture day). 100% attendance to the module lectures is not compulsory but it is strongly recommended. Anyway, the teacher will take the roll call in class.