Funding available to Develop Innovative Analytical Technologies for Vaccines

Calls for Proposals invite innovators worldwide to apply to their scientific programmes to advance the development and manufacture of vaccines and tools against epidemic and pandemic threats.

Goals

• Reducing the time of vaccine development, manufacturing and release including, but not limited to:
  • Technologies that can replace cell-based bioassays as surrogate potency alternatives
  • Alternatives to current sterility methods, to avoid reliance on growth cultures
• Reducing the current personnel costs and skill requirements for running analytics related to vaccine attributes such as Identity, Content, Integrity, Purity, Potency, or Safety.
• Globally deployable technologies for equitable access and regional testing in LMICs (Low- and Middle-Income Countries).
• Technologies that provide new characterisation insights to the priority vaccine modalities of RNA/LNP, viral vectors and protein-based vaccines.

Focus Areas

• Minimising time/cost to release/develop vaccine:
  • Novel technologies that minimise the release time of vaccines: Sterility, Mycoplasma testing (locally) and cell-based potency assays are the priority.
  • Novel technologies that minimise the speed, cost and complexity of biological methods: Sequencing, PCR, ELISA and Flow Cytometry are of particular concern, and biosensors for rapid PAT (in-Process Analytical Testing) are of interest.
  • Novel technologies that reduce the time to develop and manufacture biological reagents as immunoassay or alternative methods to immunoassays-Potency & ID methods.
• Vaccine Characterisation
  • Novel technologies for characterising vaccine products: mRNA/LNP, protein subunits and viral vectors are prioritised. Characterisation is needed to support comparability studies and tech transfer to LMIC facilities.

Funding Information

• The total budget for this CfP is $10.7M, and projects should have a timeline not exceeding 30 months (total). Two stages are involved:
  • Stage 1: For a budget not exceeding $0.2M, for up to 12 months, an initial “proof of concept” project will demonstrate that the technology can detect a vaccine relevant analyte to the expected levels of sensitivity/specificity/quantitation as required.
  • Stage 2: Applicants with technologies that show successful proof-of-concept, either following stage 1 completion, or where existing legacy data are available, are eligible to apply for up to $0.8M for an 18-month development phase to “commercial design freeze/ready for validation”.

Eligible Activities

• Activities in scope:
  • Activities related to the development, optimization and repurposing of analytical platforms for vaccine manufacture, from sectors such as IVD/Defence/Water/Food etc, to demonstrate potential for implementation in a vaccine development and/or manufacturing campaign.
  • Activities related to the implementation of in-line, at-line or near-line analytics/sensors for real time in-process control and monitoring of the manufacturing process.
  • Comparability studies between the new technology and the established methods.
  • Generation/supply of vaccine manufacturing in-process, drug substance and drug product mock samples.
• Activities out of scope:
  • Development of an analytical “Idea/concept” is out of scope. The proposed technology must have demonstrated that it works.
  • Technologies that cannot be associated to known quality attributes of a vaccine.
  • Technologies focused on manufacturing methods.
  • Platforms that cannot show significant reduction in speed, CoGs (Cost of Goods) or FTE (Full Time Equivalent) burden.

Eligibility Criteria

• Applicants (individual organizations or consortia) developing analytical technologies, must provide information in their application to show that their proposal meets the following eligibility criteria:
  • The technology is either already available on the market for applications other than vaccines or can be commercialized within three years, has shown that it works and can produce useful data for vaccine proof-of-concept purposes or is already used for other purposes and can be adapted for vaccine production.
  • The technology substantially reduces the time and/or FTE burden required to generate a valid result from a sample.
  • The technology reduces the reliance for the high skill level required, to run the traditional method.
  • The technology can be developed into a single box or modular solution.
  • The application describes a development plan to advance the technology, with a timeline not exceeding 30 months and a budget not exceeding $1 M.
  • Applicants for novel characterisation must demonstrate what additional insights the technology brings, that aren’t currently available and justify why this may be important.

Review Criteria

• Minimising time/cost to release/develop vaccine
• Vaccine Characterisation
• Innovativeness
• Route to implementation
• Partnership

For more information, visit CEPI.