Production of biopharmaceuticals: from recombinant proteins to Advanced Therapeutic Medicinal Products (ATMPs), 6.0 credits

Entry requirements

Entry requirement for studies on third-cycle education courses

• second-cycle degree,
• 240 credits in required courses, including at least 60 second-cycle credits, or
• acquisition of equivalent knowledge in some other manner

Undergraduate-level knowledge of biochemistry, cell and molecular biology.

Specific information

This course is intended for PhD students in applied physics, bioengineering. biotechnology, biomedicine, biomedical engineering, , and related interdisciplinary fields who are interested in the development, translation, and production of biological drugs and advanced therapies. The course is particularly relevant for students aiming for careers in the biopharmaceutical and biotechnology sectors, including research and development, process development, manufacturing, quality control, regulatory science, and translational medicine. It is also well suited for students pursuing academic research who wish to gain a broader understanding of how biological drugs are developed beyond the discovery stage, including the practical, technological, and industrial considerations that influence how therapies are produced, optimized, and implemented in healthcare. Owing to the interdisciplinary nature of the field, the course is relevant for students with backgrounds spanning life sciences, engineering, materials science, chemistry, physics, and biotechnology, especially those interested in working at the interface between fundamental research and real-world therapeutic applications.

Learning outcomes

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.

Contents

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 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.

Educational methods

The course is based on a combination of lectures and seminars, and a project assignment. During the lectures, the lecturer will introduce the content delineated above, and the students will have reflection occasions to assess their learning and exchange feedback with their lecturer. During the seminars, the students will have the opportunity to engage in discussion with guest speakers with significant experience in specific biotechnological applications, in industry and academia. The project assignment is conducted in small groups and will cover a relevant topic on the subject of the course. The assignment is presented as a written report and during an oral presentation. The report will be peer-reviewed by colleagues, who will also lead the discussion following the oral presentation.

Examination

Lectures do not have mandatory attendance.

Examination:

• Group project report + seminar. Mandatory attendance to group seminar.
• Written exam.

Students who fail the written exam are offered one re-examination occasion in close connection to the course. Students that cannot attend the compulsory seminar are offered an alternative date.

Grading

Course literature

A list of recommended literature will be provided by the course coordinator before the start of the course.

General information

The course is planned and carried out according to what is stated in this syllabus. Course evaluation, analysis and suggestions for improvement should be fed back to the Research and PhD studies Committee (FUN) by the course coordinator.

If the course is withdrawn or is subject to major changes, examination according to this syllabus is normally offered at three occasions within/in close connection to the two following semesters.