Pre-Clinical Development

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 

 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.

pre-clinical development routemap Go to discovery map. Go to clinical development. Go to TPP. Go to TPP Go to Regulatory affairs and ethics. Go to process developement. Go to Large animal model. Go to Large animal model. Go to GMP. Go to Masterseed bank. Go to Re-cloning strain development. Go to Invitro studies. Go to Early process development. Go to Vaccine characterisation.