Vaccine Development Process Map

Pre-Clinical Development - List view

Bottlenecks in the process are marked with a B.

All are standard proces unless stated otherwise.

Vaccine candidate – development phase

  1. Lead(s) identification
  2. Pre-GMP Masterseed bank (essential go/no go step) B
  3. Lead(s) Development
    1. Analysis of immune response: efficacy and safety of formulation correlates of protection
  4. Re-cloning, strain development and antigen presentation B
    1. Vaccine characterisation, formulation (CQAs) and adjuvantisation B
    2. Quality Control, Stability testing (essential go/no go step)
  5. Early process development B
    1. Quality control potency assay (essential go/no go step)
    2. Checklist: Efficacious, safe; Preliminary correlates of protection; Quality of product; Acceptable titres; Stable formulation (essential go/no go step)
  6. Animal Studies - In vitro studies
  7. Animal Studies - In vivo studies B
    1. Home office licence/approval (ongoing)
    2. Repeat – second animal model (optional)
    3. Model choice: Existing well developed, Novel, NHP (optional) B
    4. Analysis of immune response: efficacy and safety of formulation, correlates of protection (If favourable continue to Step 8, if unfavourable go back to Step 3)
  8. Lead product(s) identified
  9. Process Development (CPPs) – Tech transfer operations B
    1. Process Analytics: In process controls, Product/Impurities characterisation, release assays (QA/QC)
    2. Process Flowsheet and optimisation: Process Flow Sheet, CPPs/CQA, SOPs and sample data, MCB.WCB transfer or creation
    3. Pilot scale-up studies
    4. Use of pilot lots in developmental studies
  10. Reassess TPP (ongoing)

    11. Process Validation and clinical manufacture

  11. QC and stability testing
  12. Fill/finish
  13. Engineering batches to finalise process
  14. Animal Tox Study (Reproductive)(CTA Data) (essential go/no go step) (If unfavourable go back to Step 3)
  15. GMP manufacture (BULK) B
    1. QC and stability testing
  16. GMP manufacture (fill/finish) B
  17. Prepare Clinical Trial Applications (CTA/IND filing)
  18. Clinical Development
    1. Tech transfer documents if manufacturing at scale (SOPs, TPP) (optional)

Ongoing throughout  process:

Next map list – Clinical development