90914 - INDUSTRIAL SCALE UP OF BIOPROCESSES

Course Unit Page

  • Teacher Cristiana Boi

  • Credits 3

  • SSD ING-IND/25

  • Language English

  • Campus of Bologna

  • Degree Programme Second cycle degree programme (LM) in Pharmaceutical Biotechnology (cod. 9068)

  • Course Timetable from Nov 03, 2021 to Nov 30, 2021

SDGs

This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.

Good health and well-being

Academic Year 2021/2022

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

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

From the laboratory bench to the industrial production of biopharmaceuticals: principles and methods to obtain products of the desired quality and purity.

What is the scale-up of a process for biophamaceutical production and how it differs from the scale-up of a chamical process. 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: antibiotics, insulin, monoclonal antibodies, viral vectors for gene therapy.

Antiobiotic production: process analysis and economic evaluation. Scale-up of the extraction process.

Recombinant insulin production.

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

Gene therapy: the challenge of the industrial production of viral vectors. Example of scale-up of the AAV2 process.

 

 

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 and term paper.

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 biopharmaceutical industry;

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

The final assessment will be via a written exam and an oral part. The written assessment is a quiz with simple exercises or theoretical questions on the course topics. The score is given in thirtieths. The goal of the oral part is to ascertain the full understanding of both the basic principles and the design rules of equipment and processes considered during the course. The score of the oral part is given in thirtieths. The global score takes into account the results obtained both in the written and in the oral assessments.

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.

Reading material that will be made available during the course in a shared folder on Onedrive as well as guided suggestions for individual literature search.

Office hours

See the website of Cristiana Boi