Pharmaceutical Biotechnology

Biopharmaceutical products (i.e. therapeutic proteins, vaccines, gene and cell therapies) are essentially different from other biotech products in the sense that it is a high value product with very specific requirements in terms of safety and efficacy, in short product quality. Biopharmaceutical process engineers require skills in management of process variance and subsequently variance in product quality while being in compliance with (GMP) regulations through understanding of the underlying (cellular) processes. In this course we will cover all aspects of biopharmaceutical development from cell line development, cell culture, purification, product analysis, quality control aspects and process engineering. This course cannot be combined in an individual programme with BPE33803.

After successful completion of this course students are expected to be able to:

• recall the steps in a pharmaceutical process development value chain;
• explain how the steps in a pharmaceutical process development value chain relate to process scale, GMP requirements and associated development costs;
• perform the following steps of a biopharmaceutical production process: cell culture, sterile handling of cells, bioreactor operation, product purification and analysis of cell viability, product-, nutrient-, metabolite- and cell concentration and product quality;
• apply the outcomes of these analyses to assess the state of the process and to design a strategy to adjust process parameters such as stirring, aeration or feeding when necessary;
• recall the specific physiological properties of animal cells that are relevant for biopharmaceutical process development;
• evaluate the relevance of different bioreactors and culture strategies for animal cell culture;
• design a bioreactor for animal cell cultivation based on biological and physical constraints;
• design a virus production process;
• optimize process settings based on knowledge on the relationship between process parameters and product formation and quality;
• explain how available process analytical tools for bioprocess monitoring can be used for process monitoring and control and discuss their value during process development and routine manufacturing of biopharmaceutical products;
• recall, explain and apply the principles of Quality by Design and other process quality systems in biopharmaceutical development, including calculations of key performance indicators;
• recall the different purification steps and their working principle for a pharmaceutical protein;
• discuss the integration of the purification process in the total pharmaceutical production process

Mandatory Knowledge:
ZSS06100 Laboratory Safety
Assumed Knowledge:
BPE22306 Basic Cell Factory Design;
FHM31806 Biotechnology 2.