Pre-Clinical Discovery

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:

Next map list – Pre-clinical development 

Underlined nodes have further information and can be selected. Those using assistive technologies can access the full information using the list view of the map. 

discovery routemap Go to regulatory affairs. Go to regulatory affairs. Go to regulatory affairs. Go to 8.1 In vitro studies Go to 8.2 In vivo studies Go to regulatory affairs. Go to Target product profile. Go to vaccine identification Go to regulatory affairs. Go to Freedom to operate Go to Human/Livestock. Go to pre-clinical developement Go to Pathogen Biology.