Vaccine Bioprocess Development
Dr Tarit Mukhopadhyay
Three-hour written examination (70%)
Two pieces of coursework (30%)
This is an end-to-end course that seeks to instruct in the various stages of vaccine development and commercialisation. As many vaccines are administered to healthy individuals the regulatory requirements shape development unlike any other biopharmaceutical. Students will learn about the historical importance of early vaccines, the modification to the ‘regulatory lock,’ and process development challenges for vaccine manufacture.
Following completion of the course, students will have an understanding of:
- how to identify active and passive immune therapies
- the regulatory burden for vaccine manufacture
- how to distinguish between process choices for bacterial and viral vaccines
- antigen design
- how to distinguish between the multiple methods of action for an adjuvant
- vaccine development within a closed ‘artificial’ market
- how to make cost bases analyses on process changes
- ‘production at risk’
Coursework and case studies: 40h
The course will cover production, development and product purification; assay construction and qualification, and protection of intellectual property in a global market. The breakdown will be:
- Vaccine Overview: Overview of vaccine evolution from live, attenuated, subunit to reverse vaccinology
- Basic Immunology: Basic concepts of humoral, cell mediated responses. Cytokine and chemokine stimulation and signalling – passive and active protection.
- Bacterial Vaccines: Meningitis A, C, W135 (conjugate vaccines), Meningitis B (non-conjugate vaccines), Anthrax vaccine (toxoid based vaccine), Process development and modernisation of vaccines
- Viral Vaccines: Measles, influenza, Adenovirus – enveloped and non-enveloped viruses
- Adjuvants and Formulation: Adjuvant overview, novel adjuvants and TLR agonists. Liquid and Lyophilisation and novel formulations to avoid the cold chain.
- Vaccine Economics: TRIPs and Intellectual Property, Emerging Markets, Internalisation and Diversification
- Assay Development and Regulation: Overview of the standard assays used for vaccine release, test criteria, creating and validating a new assay for a novel target and the regulatory requirements.
- Future Trends: New targets, gene therapy, cancer vaccines, diabetes