Clinical Vaccine Development and Biomanufacturing

This four day Clinical Vaccine Development and Biomanufacturing course can be taken either independtly or as an add-on to the Human and Veterinary Vaccinology course. The course will be designed in close collaboration with clinicians, veterinarians and industrial partners who conduct clinical trials to provide:

• An overview of pre-clinical testing and the pathway from pre-clinical testing to field trials.
• A more detailed discussion of vaccine immunogenicity, testing vaccine immunogenicity in the field and the need for correlates of immune protection. The different phases of vaccine testing from Phase I to IV.
• An overview of the development of veterinary vaccines.
• An introduction to the principles and conduct of Good Clinical Practice.

The vaccine biomanufacturing section of this course will be designed in close collaboration with our industrial partners to provide:

• An overview of vaccine markets and growth drives for developed and developing settings.
• An overview of the biomanufacturing processes used for the production of a spectrum of vaccines.
• The principles of GMP (Good Manufacturing Practice) and how these are applied to vaccine production.
• An introduction to Quality Assurance and the use of molecular methods to verify quality.