Biopharmaceutical Development and Production

Department

Master's Program Biotechnology

Course unit code

BT_MA16_3_3

Number of ECTS credits allocated

2.0

Name of lecturer(s)

Dr. Rogl Hans, Dr. Deutschmann Sven, Dr.-Ing. Emmler Markus, Dr. Strauss Ulrike, Kuhne Felix, MSc, Dr. Tebbe Hermann, Dr. Klein Barbara, Dr. Abmayr Simone

Mode of delivery

face-to-face

Recommended optional program components

none

Recommended or required reading

Madigan, M.T. et al: Brock Mikrobiologie, Pearson Studium, 2008
Schlegel, H.G., Fuchs, G.: Allgemeine Mikrobiologie, Thieme, 2006
Berg, J.M. et al: Biochemie, Spektrum Akademischer Verlag, 2007
Voet, D.J. et al.: Lehrbuch der Biochemie, Wiley-VCH, 2002
Horton, H.R. et al: Biochemie, Pearson Studium, 2008
Wink, M.: An introduction to molecular biotechnology, Wiley-VCH, 2006
Thieman, W. and Palladino M.: Introduction to Biotechnology, Pearson, 2009
Renneberg, R.: Biotechnologie für Einsteiger, Spektrum Akademischer Ver-lag, 2006.

Assessment methods and criteria

Exam

Level of course unit

Master

Year of study

Fall 2025

Semester when the course unit is delivered

3

Language of instruction

English

Learning outcomes of the course unit

In this course, students are familiarized with the conditions, procedures, and characteristics of the biopharmaceutical industry. By drawing on typical products of the sector, students are taught the individual steps of production from research and development, fermentation and processing to respective analyses and quality assurance. Our graduates are also familiar with relevant concepts such as Quality by Design and platform technologies.

Course contents

• Research strategies of biotechnological companies
• Product selection and feasibility studies
• Product development
• Fermentation planning, reactor design, fermentation
• Downstream processing (industrial chromatography, separation of cells, filtration, extraction)
• Platform technologies
• Pharmaceutical project management
• Quality by Design
• Quality control and validation
• Good manufacturing practice
• Production strategies (in-house, 3rd party, partnering)

Planned learning activities and teaching methods

lecture

Work placement(s)

none