ID:
509956
Durata (ore):
24
CFU:
3
SSD:
CHIMICA FARMACEUTICA
Anno:
2024
Dati Generali
Periodo di attività
Primo Semestre (30/09/2024 - 17/01/2025)
Syllabus
Obiettivi Formativi
The aim of this module is to provide knowledge on advanced analytical separation techniques, including theory, instrumental aspects as well as applications to the qualitative and quantitative analysis of biotechnological drug products. 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 research articles related to the contents acquired.
Prerequisiti
To attend this module basic knowledge of analytical chemistry, spectroscopy and liquid chromatography (HPLC) is required. Before attending this module it is strongly suggested to first attend the module "Analytical Techniques for Biotechnological Drugs" (MODULE 1).
Metodi didattici
Teaching methods include lectures in class, discussion in class of the lecture topics, reading and discussion in class of research papers related to the Analysis of Biological/Biotechnological drug products in the Biopharmaceutical Industry.
Verifica Apprendimento
Oral exam. The student will have to demonstrate to have acquired knowledge on theory and application of separation techniques for the analysis of biotechnological drug products, also in the context of industrial quality control (analytical method validation, specifications, stability)
Testi
*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.
*ICH Topics covered by the programme to be found at EMEA site: https://www.ema.europa.eu/en
*Selected research papers will be passed out by the lecturer to the students
*CE: 1) Agilent Technologies, High performance Capillary Electrophoresis, an introduction. 2) Ahuja, S. Jimidar MI: Capillary electrophoresis methods for pharmaceutical analysis , Academic Press; 2008.
*ICH Topics covered by the programme to be found at EMEA site: https://www.ema.europa.eu/en
*Selected research papers will be passed out by the lecturer to the students
Contenuti
To complete the knowledge acquired on liquid chromatography (HPLC) in MODULE 1, the first part of this module (MODULE 2) will focus on:
*From Micro and NanoLC to Ultra Performance Liquid Chromatography (UPLC).
Then, an orthogonal separation technique will be introduced, including applications to the analysis of biotechnological drug products:
*Capillary Electrophoresis (CE): Basic principles; CE modes (CZE, MEKC, CCE, CEC, CGE, CIEF, CITP, ACE); Advanced CE.
Further, ICH documents (Scientific Guidelines for Pharmaceutical/ Biopharmaceutical Industry) will be critically discussed, in particular:
Topic Q2(R2) Validation of Analytical Procedures and ICH Q14 Guideline on Analytical Procedure Development; Topic Q6B Specifications: Text procedures and acceptance criteria for biotechnological/biological products; Topic Q1A Stability testing Guidelines. Stability testing of new drug substances and products;
The module will conclude with:
Reading and discussion of research papers related to the analysis of Biological/Biotechnological products in the Biopharmaceutical Industry.
*From Micro and NanoLC to Ultra Performance Liquid Chromatography (UPLC).
Then, an orthogonal separation technique will be introduced, including applications to the analysis of biotechnological drug products:
*Capillary Electrophoresis (CE): Basic principles; CE modes (CZE, MEKC, CCE, CEC, CGE, CIEF, CITP, ACE); Advanced CE.
Further, ICH documents (Scientific Guidelines for Pharmaceutical/ Biopharmaceutical Industry) will be critically discussed, in particular:
Topic Q2(R2) Validation of Analytical Procedures and ICH Q14 Guideline on Analytical Procedure Development; Topic Q6B Specifications: Text procedures and acceptance criteria for biotechnological/biological products; Topic Q1A Stability testing Guidelines. Stability testing of new drug substances and products;
The module will conclude with:
Reading and discussion of research papers related to the analysis of Biological/Biotechnological products in the Biopharmaceutical Industry.
Lingua Insegnamento
INGLESE
Altre informazioni
Slides will be made available to attending students. 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 rules, 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. Students who attend less than 75% of the whole module (i.e. less than 18 hours) will get a maximum mark of 27/30. The teacher will take the roll call in class.
100% attendance to the module lectures is not compulsory but it is strongly recommended. Students who attend less than 75% of the whole module (i.e. less than 18 hours) will get a maximum mark of 27/30. The teacher will take the roll call in class.
Corsi
Corsi
MEDICAL AND PHARMACEUTICAL BIOTECHNOLOGIES
Laurea Magistrale
2 anni
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