Vaccine Development Process Map

Veterinary Vaccine: Early-phase Development

Bottlenecks in the process are marked with a B.

All are standard proces unless stated otherwise.

Vaccine candidate – laboratory testing

  1. Lead(s) identification
  2. Pre-GMP Masterseed bank (essential go/no go step) B
  3. Lead(s) Development
  4. Re-cloning, strain development and antigen presentation B
    1. Vaccine characterisation, formulation and adjuvantisation B
    2. Quality Control, Stability testing (essential go/no go step)
  5. GMP master seed banks B
  6. Process development B
    1. Process Design
      1. Process Analytics (1. In process controls, 2. Product/Impurities Characterisation, 3. Release Assays (QA/QC) )
      2. Process Flowsheet and optimisation (1. Process Flow sheet, 2. Critical Process Parameters (CPP)/Critical Quality Attributes (CQA)s, 3. SOPs and sample data, 4. Master Seed Bank transfer and testing)
    2. Pilot scale-up studies
    3. Use of pilot lots in developmental studies
  7. Produce minimum and maximum potency batches B
  8. The following steps 8 to 11 are in parallel.

  9. Potency assay (essential go/no go step)
    1. Quality, purity and consistency: Starting materials, Manufacturing process, Process quality control, Product quality control (essential go/no go step) B
    2. Checklist: Efficacious, Prelliminary correlates of protection, Quality of product, Acceptable titres, Stable formulation (essential go/no go step)
  10. In vivo safety: Maximum titre/potency, Single, repeat (overdose), Minimal age, Pregnant animals, Live vaccine studies B
  11. In vivo efficacy: Minimum titre/potency, Onset of immunity, Duration of immunity, Minimal age, Requirement for boosters, Impact of maternally derived antibodies, Immune mechanism B
  12. Analysis of immune response: efficacy and safety of formulation, correlates of protection.  (If favourable continue to Step 12, if unfavourable go back to Step 3)
  13. Lead product(s) identified (essential go/no go step)
  14. Reassess TPP
  15. Process Validation and Manufacturing scale-up

    The following steps 14 to 17 are in parallel.

  16. QC and stability testing
  17. Fill/finish
  18. Engineering batches to finalise process
  19. Environmental safety, Consumer safety, User safety (essential go/no go step) (If unfavourable go back to Step 3)
  20. GMP manufacture (BULK) B
    1. QC and stability testing
  21. GMP manufacture (fill/finish) B
  22. Field trial Application (ATC) (essential go/no go step)
  23. Late-phase Development and registration
    1. Tech transfer documents if manufacturing at scale (SOPs, TPP) (optional)

Ongoing  throughout  process:

Next list view of map – Late-phase Development and Registration Map