96263 - Industrial Scale Up of Bioprocesses

Learning outcomes

At the end of the course, the student acquires basic knowledge on methodologies for the scale up of processes aimed at the production of biotechnological pharmaceuticals, from the laboratory level to the pilot plant up to the industrial one, and is familiar with the main operations used in the biotechnology industry.

Course contents

This module is part of the integrated course Industrial Biotechnological Applications and is structured as a follow-up to module 90913 Downstream Processes of Biological Molecules. Erasmus or international exchange program students should select both modules.


Course Contents:

Basic introduction to chemical engineering fundamentals to understand industrial process design.

Bioreactors: types of bioreactors, operating modes, components, areation, mixing and scale-up

From the laboratory bench to the industrial production of biopharmaceuticals: process development, principles and methods to obtain products of the desired quality and purity, regulatory aspects.

Criteria to choose the optimal unit operations to obtain the desired biopharmaceutical product.

Use of process simulators to size apparatuses and bioprocess design.

Example of biopharmaceutical production:

- Recombinant insulin production: process analysis and economic evaluation. Analysis of critical issues and potential process improvements.

- Monoclonal antibody production: process analysis and economic evaluation. Analysis of critical issues and potential process improvements. Scale-up of a chromatography column.Polishing steps: AEX, CEX, HIC and mixed mode chromatography.

- Citric acid production: process analysis and economic evaluation. Analysis of critical issues and potential process improvements.

Readings/Bibliography

R.G. Harrison, P. Todd, S. Rudge and D. Petrides, Bioseparations Science and Engineering, 2nd Ed. Oxford U. Press, NY, 2015.

Process scale bioseparations for the biopharmaceutical industry, A.A. Shukla, M.R. Etzel. S. Gadam Editors, CRC, Taylor & Francis, 2007.

Teaching methods

Lectures.

Assessment methods

The aim of the final examination (one for the whole course) is to evaluate the achievement of the main goals of the course, specifically:

- the capability to adopt suitable analysis and calculation techniques, which are presented during the course, in order to understand the working principles of the equipment and the basis design rules, in addition to the understanding of the chemical and physical phenomena occurring in equipment and processes of the chemical industry;

- the capability to use the outcomes obtained by the above analysis to improve the performances of equipment and processes of the chemical industry.

The final assessment will be via an oral exam. The goal of the exam is to ascertain the full understanding of both the basic principles and the design rules of equipment and processes considered during the course.

A passing grade (greater than or equal to 18/30) can only be refused once.

Teaching tools

A combination of blackboard and slide projector according to the lecture topic.

Power point presentations that will be made available on Virtuale with access to University of Bologna students.

Office hours

See the website of Riccardo Onesti