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Biochemical Engineering

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Vaccine Bioprocess Development

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Course Title BENGM028
Year Four
Credits 0.5
Course Tutors Dr Tarit Mukhopadhyay
Assessment Three-hour written examination (70%)
Two pieces of coursework (30%)
Prerequisites
BIOC 2007, BENG 3012, BENG 3004

Aims

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. 

Learning Hours

Includes:

Lectures: 30h
Coursework and Case Study: 40h

Syllabus

  • 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