Production of Biopharmaceuticals

Aim

In the course, the students will learn what the different classes of biological drugs (biopharmaceuticals) are, what distinguishes biological drugs from other types of drugs, and howe different classes of biopharmaceuticals are produced. Students will learn how different types of biological drugs can be produced biotechnologically on different scales, from early development phase to industrial or patient-specific production, and how the nature of the drug affects its production process. Students will also gain an insight into different types of host cells used for the production of biological drugs, with a focus on eukaryotic cell systems, as well as knowledge of different methods for purification and quality control of different products. Particular emphasis will be placed on Advanced Therapy Medicinal Products (ATMPs) and how these specific types of biological drugs are produced and used.

By the end of the course, the students should be able to:

• Describe the different types of biological drugs, their properties, and their production process and explain how the properties of the biological drugs affect the production process.
• Explain Quality by Design approaches and apply them to the development of biological drugs production processes.
• Critique existing production processes and select the most appropriate approaches.
• Create production processes for existing and new biological drugs and reflect on the theorical bases of their design.

Content

The course covers different types of biological drugs, such as monoclonal antibodies, insulin and other recombinant proteins, peptides, vaccines, blood and plasma products, and drugs based on cells, tissues, or genes (so-called Advanced Therapy Medicinal Products). Properties of different types of biological drugs are discussed as well as specific methods for producing biological drugs. Methods for both small- and large-scale production as well as production of patient-specific biological drugs are discussed, including both upstream and downstream processes, as well as methods for purifying products and ensuring product quality. Different cell systems used for the production of recombinant proteins are treated, with a focus on eukaryotic cells, as well as how they are cultured and what factors affect product yield and product quality. The course also provides a general introduction to tissue engineering for therapeutic purposes. A key aspect of this course is the critical evaluation, the ability to optimize and to create biotechnological processes for the production of biopharmaceuticals. Optimization of production processes in the light of sustainable development will be discussed and assessed.