Ateneo - UPO

The course is composed of two parts. The first part is focused on the microbiological control of pharmaceutical products. In particular: • Sterilization and sterility assurance of pharmaceutical products • Assays and methods for the microbiological evaluation of pharmaceutical products • Sampling and analysis of pharmaceutical environments to minimize microbial survival. • Pyrogens and endotoxin testing in injectable products The second part is dedicated to the industrial microbiology. In particular, the following topics will be addressed: • The fermentation processes: measures and regulation, culture media and raw materials • Isolation and selection of industrially relevant microorganisms • Methods for the production of microbial metabolites • Evaluation of microbial growth • Recovery of fermentation products (downstream) • Microbial biomass

Handbook of microbiological quality control: pharmaceuticals and medical devices Edited by Rosamund M. Baird, Norman A. Hodges, Stephen P. Denyer. - New York: CRC Press, c2000.-XVI, 254 p. Industrial Microbiology: An Introduction Edited by Michael J. Waites, Neil L. Morgan, John S. Rockey, Gary Higton; John Wiley & Sons, 01 apr 2009-304 p. Brock Biology of Microorganisms, Global Edition. Pearson

The course aims to provide students with a theoretical overview of the main methods currently used in the microbiological quality control of pharmaceutical products. Moreover, the knowledge of the fundamental aspects of applied microbiology related to the microbial fermentation systems and recovery of the end-products will be acquired. In particular, at the end of the course the students will acquire expertise related to different aspects of the Applied Microbiology, including: - Methods currently used for the microbiological control of pharmaceutical products and skills in the critical analysis of results; - Strategies and procedures for a correct production process of drugs from a microbiological point of view; - Selection, characterization and use of microorganisms for industrial and production processes; - Methodologies and technologies for the optimization of fermentation processes. Objective of the course will also be to stimulate the critical spirit of the students by analyzing topical issues and curent events related to the applied microbiology, and by reading and commenting on scientific articles.

Skills about the structure and function of the prokaryotic cell, the microbial metabolism, the methods of cultivation and quantification of microbial cultures. This knowledge is provided by the General Microbiology teaching that takes place during the first year.

The course includes lessons delivered in the classroom. Some topics will be deepened with videos in English and Italian. Some topics will be deepened with videos in English and Italian. Topics of particular interest and relevance will be examined with the critical reading and commentary in the classroom of scientific publications. At the end of each part of the course, exercises and group (in the classroom) or individual work (to be done at home) such as the case study will be conducted

The slides of the lectures and supplementary material are available on the website “Didattica in Rete”: https://www.dir.uniupo.it/
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.

DESCRIPTION Written exam with 3 open questions and 6 multiple-choice quiz. The first two questions will be equally distributed on the two main topics of the course. In particular, they will be aimed at evaluating the knowledge and concepts acquired by the students respectively in the microbiological control of pharmaceutical products and in the industrial microbiology. The ability to apply such knowledge will be assessed through the resolution of a question in which the students will have to critically select and describe which technologies and/or methodologies commonly used in one of the two fields are necessary to solve a technical/diagnostic problem. Multiple choice questions will be distributed as follows: 3 on the topic of pharmaceutical microbiology 3 on the topic of industrial microbiology They may be of the following types: - Multiple choice question (with only one true answer) - True/false questions - Short problems on the calculation of colony forming units (CFU/mL) and preparation of solutions for microbiology. EVALUATION METHOD The score attributed to each question will be specified in the exam text. Questions related to knowledge and concepts: 10 points each Technical/diagnostic application: 6 points Multiple choice questions: 1 point each for a total of 6 points The final mark will be given by the sum of the scores of each question. Maximum total score 32 points. The achievement of 31 points will result in 30 cum laude. Open questions or multiple choice questions that are not answered or are wrong will be assigned a score of 0. The ability to answer to open questions using an appropriate technical-scientific language will also be evaluated. AVAILABLE TIME : 70 minutes.

Microbiological control of pharmaceutical products • Sterilization methods for pharmaceutical products • Biological indicators for sterilization • Sterility testing for bacteria and fungi • Validation of sterility tests • Microbial evaluation of non-sterile pharmaceutical preparations • Quantitative determination (total microbial counts, pour-plate method, filtration, Most Probable Number) • Methods for the detection of specific microorganisms (E. coli, Salmonella spp., S. aureus, P. aeruginosa, Clostridia) • Automated rapid methods (impedometry and bioluminescence) • Analysis and control of pharmaceutical environments to minimize microbial survival. • Limulus Amebocyte Lysate test (LAL) for the determination of pyrogens in injectable products Industrial Microbiology • Microbial diversity and bioprospecting: definitions and examples • Methods for the analysis of microbial communities • Isolation and selection of industrially relevant microorganisms (primary and secondary screening) • The fermentation processes • Industrially relevant metabolic accumulations • Procedures for obtaining microbial metabolites • Culture media and raw materials • Monitoring, control and technologies of fermentation processes • Evaluation of microbial growth in industrial processes • Recovery of fermentation products (downstream) • Microbial biomasses

KNOWLEDGE AND UNDERSTANDING: the student will acquire knowledge and understanding about the applications of the methods used in the areas of pharmaceutical and industrial microbiology. In particular, the student will achieve the theoretical knowledge to evaluate the microbiological characteristics of non-sterile pharmaceutical preparations, to detect and quantify the presence of pathogenic microorganisms in such products, to ensure the sterility and quantify the presence of bacterial endotoxins in sterile preparations, to evaluate the hygienic requirements of pharmaceutical environments. In addition, the student will be aware of the main technologies used for microbial fermentation in bioreactors. In particular, the main types of bioreactors will be described, as well as the control systems of the fermentation process, the different techniques of immobilization of microbial cells, the isolation of the fermentation products and the main types of biomasses. Particular attention will be paid to deepening the biological aspects of fermentation processes. In this regard, the student will acquire knowledge about the methods of isolation and selection of microorganisms of industrial interest, the use of renewable growth substrates and the quantification of microbial growth in the industrial field. APPLYING KNOWLEDGE AND UNDERSTANDING: the students will be provided with a theoretical framework and with the tools for the application of the main microbiological methods and processes currently used in the pharmaceutical and industrial sectors, to achieve the ability to critically select the technologies and the methodologies described in the two areas and to develop and deepen further skills in the microbiological field. MAKING JUDGEMENTS, COMMUNICATION AND LEARNING SKILLS: At the end of the course, the students must demonstrate autonomy of judgment, the ability to analyze operational problems and to take appropriate corrective measures in the pharmaceutical and industrial microbiological fields and to have acquired skills related to verbal and written communication through the use of an appropriate technical-scientific language.