Vaccine Development Process Map

Bottlenecks in the process are marked with a B.

All are standard proces unless stated otherwise.

1. Human/livestock host immunology B
1. Ethical Approval
2. Pathogen Biology B
3. Pathogen challenge model (Optional) B
1. Ethical approval
4. Antigen discovery and immunogen design
1. Vaccine type
2. Whole microbial
3. Subunit, vectored, glycoconjugate
4. Antigen selection and purification (Optional)
5. Growth rate, Manufacture, Safety
6. Antigen/gene of interest, vaccine vector, adjuvant
7. Proceed to in vitro/in vivo studies
5. Pre-formulation work
6. In vitro studies
7. Early in vivo
8. Animal challenge model with antigen(s) (Optional)
1. Ethical approval
9. Analysis of immune response – correlates of protection data (If favourable continue to Steps 10 and  11, if unfavourable go back to Step 4)
10. Immunisation strategy
11. Lead(s) identification
    1. Freedom to operate B
    2. Patent application

Ongoing throughout  process:

• Regulatory Affairs and ethical considerations
• Refine Target product profile

Next map list – Pre-clinical development