Dr Tarit Mukhopadhyay
Three hour examination (70%)
Two pieces of coursework (30%)
|Prerequisites||UG Process Engineering module or equivalent covering major unit operations|
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.
Intended learning outcomes following the completion of this course are:
- Identify active and passive immune therapies
- Understand the regulatory burden for vaccine manufacture
- Distinguish between process choices for bacterial and viral vaccines
- Understand antigen design
- Distinguish between the multiple methods of action for an adjuvant
- Appreciate vaccine development within a closed ‘artificial’ market
- Make cost bases analyses on process changes
- Understand ‘production at risk’
Coursework and Case Study: 40h
- 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