22230 Development and production of vaccines

2024/2025

Course information
Udvikling og produktion af vacciner
English
5
MSc
Offered as a single course
Programme specific course (MSc), Pharmaceutical Design and Engineering
Technological specialization course (MSc), Pharmaceutical Design and Engineering
Spring F4A (Tues 13-17)
Campus Lyngby
The course is conducted as a combination of lectures and group work. An excursion to SSI will be planned. Relevant guest lecturers will attend selected topics.
13 weeks
Evaluation of exercises/reports
The exam consists of two individual interim quizzes and a final written group report with individualization and an oral presentation. The grade is based on an overall assessment, with each quiz accounting for 20% and the final report with the oral presentation accounting for 60%. To pass the course, all part-exams must be completed. Illness or arranged absence from a part exam will allow for an extra part exam. No-shows in part-exams without prior arrangement with the lecturer will result in an incomplete part-exam and a failed course.
Each quiz is 60 minutes at the start of teaching in lesson 6 or 7 and lesson 13.
All Aids - with access to the internet
7 step scale , internal examiner
24102 and 27324
27322/27070 , The teaching will only briefly cover the cellular and humoral elements of the immune system and how the immune system reacts to infection. Thus it is a prerequisite that the student is already familiar with these elements of basic immunology or achieves this knowledge in parallel e.g. by taking the course in immunology (27070).
Peter M. H. Heegaard , Lyngby Campus, Building 202, Ph. (+45) 3588 6241 , PMHH@dtu.dk
22 Department of Health Technology
At the Studyplanner
This course gives the student an opportunity to prepare a project that may participate in DTU's Study Conference on sustainability, climate technology, and the environment (GRØN DYST). More information http://www.groendyst.dtu.dk/english
General course objectives
The course will deal with the challenges connected with the design, development, production and registration of vaccines based on knowledge of the immune system in human and animals. Therapeutic antibodies will also be taught. The students will acquire knowledge on vaccines for the treatment or prevention of infections, allergies, cancer and chronic inflammatory diseases. The students will understand the capacities and complexities of using the vaccinated host’s own immune system as both the target and the final executor of the desired effects of the drug. This biopharma approach to viewing vaccines as drugs is beneficial for understanding their discovery and production and also their use for preventive, therapeutic and post-exposure applications.
Learning objectives
A student who has met the objectives of the course will be able to:
  • describe the basic nature of different vaccine types (live, inactivated, killed, subunit etc.).
  • explain the different methods available for antigen discovery and production.
  • explain the method of action for adjuvants.
  • design the construct of a vaccine with selection of antigen, adjuvant and delivery.
  • design vaccine characteristics for a given application in practice, including the interplay with diagnostic assays.
  • describe general principles for toxicology and hazard identification.
  • explain the safety and efficacy aspects of vaccines and how these are tested.
  • explain how to use, empower and produce immunoglobulins as one class of biopharmaceuticals.
  • describe the principle governing preclinical and clinical testing of vaccines.
  • design vaccines against allergy.
  • design vaccines against cancer.
  • apply the knowledge obtained in the course to describe the development of a new vaccine or therapeutic antibody against a selected topic.
Content
This course will teach basic vaccinology such as different types of vaccine, administration of vaccines, and the immunology behind vaccine and adjuvant effects and explain some of the practical considerations behind using vaccines in humans and animals. Fundamental concepts in toxicology and hazard identification will be taught. Special considerations in vaccination against infections, cancer, or in the treatment of allergy will also be taught.

As an example of drug development and production, the process of developing and producing vaccines will be taught, from the definition of an antigen with the optimal characteristics of ease of production, stability and immunological relevance through the selection and/or development of adjuvants and testing in animals, to the final production and formulation of a vaccine for a specific use. This also includes requirements from authorities in the approval of a vaccine production and preclinical and clinical testing of vaccines. Finally, design and production of therapeutic antibodies will be taught.
Course literature
There is no individual textbook that covers the development of vaccines in the same way as the course. Relevant scientific articles will be used along with other shared material.
For general background and reference, it is necessary to have access to a text book in general immunology such as Janeway's Immunobiology, which is also used in course 27070.
Last updated
25. juni, 2024