Vaccine Development Process Map

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

The following steps 8 to 11 are in parallel.

8. 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)
9. In vivo safety: Maximum titre/potency, Single, repeat (overdose), Minimal age, Pregnant animals, Live vaccine studies B
10. 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
11. 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)
12. Lead product(s) identified (essential go/no go step)
13. Reassess TPP

Process Validation and Manufacturing scale-up

The following steps 14 to 17 are in parallel.

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

Ongoing  throughout  process:

• Regulatory Affairs and ethical considerations - UK and 'in country' where vaccine may be tested
• Target product profile

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