Vaccine Development Process Map

Bottlenecks in the process are marked with a B.

All are standard proces unless stated otherwise.

1. Livestock or companion animal host immunology B
1. Ethical Approval
2. Pathogen Biology B
3. Pathogen challenge model (Optional) B
1. Ethical approval B
4. Antigen discovery and immunogen design
1. Vaccine type
1. Whole antigen (Viral, Bacterial, Parasite)
1. Growth rate. Manufacture, Attenuated or inactivated, Adjuvant/delivery
2.  Nucleic Acid, VLP, Subunit, Vectored, Glycoconjugate
1. Antigen selection and purification
2. Antigen/gene of interest, Vaccine vector, Adjuvant, Delivery System
2. Proceed to in vitro/in vivo studies
5. Pre-formulation work
6. In vitro studies
7. Early in vivo
8. Challenge model with antigen(s) B
1. Ethical approval
9. Analysis of immune response – correlates of protection data (If favourable continue to Steps 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