Pharmaceutical Biotechnology

Biopharmaceutical products have been transformative for health care, an excellent example of how impactful biotechnology is on society. However, such sophisticated products are also difficult and therefore expensive to produce. In this course, we will go over all aspects of biomanufacturing these crucial products, from upstream to downstream, and also how patient safety is taken into account during process development and execution. In addition, we will cover state-of-the-art analytical techniques that help us understand and automate these processes, and therefore make them more cost-effective and robust. We will cover different types (so-called modalities) of biopharmaceuticals, such as protein-based therapeutics and cell therapy. Moreover, during the group work you will dive into the details of the process for one of these modalities yourself and hear about others via group presentations.

Below you can find a comprehensive overview of the course content:

·         General introduction to biopharmaceutical processing

·         Upstream processing (protein-based, viral vectors, gene therapy, cell therapy)

·         Downstream processing techniques

·         Formulation and filling

·         Analytical techniques

·         Regulatory aspects

Presentation

·         Intermediate presentation (feedback,  no grade)

·         Final presentation (group grade, 50% of final grade)

Written exam (individual grade, 50% final grade)

A minimum of 5.0 is needed for each item (presentation and written exam) to pass the course.

A final grade (average of final presentation and written exam) of 5.50 or higher is needed to pass the course.

The written exam has a resit and the same presentation grade will be used to determine a final grade with the grade obtained for the resit.

The group work can only be redone in the next year.

The exam grade will be kept for 1 year, unless this is also redone the next year. After 1 year, both the presentation and the exam will have to be redone.