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. 2019 Mar 22;37(17):2415–2421. doi: 10.1016/j.vaccine.2019.01.050

Table 1.

Summary of the vaccine development tool bottlenecks. These bottlenecks identify generic rate-limiting stages in vaccine development that could be alleviated through further research spending, changes in policy of investment into infrastructure.

Stage in development Short description Type of bottleneck
Pre-clinical discovery
  • Pathogen biology including
    • -
      Human-host immunology
    • -
      Pathogen Challenge model
  • Freedom to operate

  • Research

  • Policy




Pre-clinical development
  • Process development including,
    • -
      Critical process parameters
    • -
      Critical quality attributes
    • -
      Adjuvants and formulation
  • Animal model choice

  • Scale-up and clinical manufacture
    • -
      GMP bulk
    • -
      GMP fill-finish
  • Research

  • Research

  • Infrastructure




Clinical development
  • GMO regulation

  • Trial sites and NRA approval

  • Regulatory and ethical approval

  • Policy