A ‘Platform’ follows a specific, well-defined process using specific platform technologies, equipment, analytical methods, formulations and a specific Quality Management System to make products with uniform specifications and highly predictable characteristics. Platform technologies can be used in more than one vaccine without significant impact to manufacturing, quality or safety and can bring major efficiencies to vaccine development, manufacturing, testing and regulatory review processes.
Use of platforms can facilitate rapid development, emergency use authorization and licensure of vaccines in response to a public health emergency. Ongoing evaluation of the status of existing platforms will help us quickly assess their readiness and the potential they offer for a rapid response. A checklist of recommended parameters to use in that evaluation, along with recommended scoring to aid in the evaluation is provided below:
Pathogen Compatibility
Pathogen Compatibility: Has the platform been used for a pathogen in the same viral family? (1 – no; 2 – yes)
Platform Suitability
Categorization: What category is the platform? (1 – potential platform used for no licensed products; 2 – designated platform used for one licensed product; 3 – established platform used for more than one licensed product)
Safety: Do vaccines manufactured using the platform have a positive risk-benefit outcome, demonstrating acceptable safety? (1 – no, there have been significant adverse events with no known mitigation strategy at a frequency that would outweigh the benefit; 2 – yes, but there have been significant adverse events that would need to be mitigated for the benefit to outweigh the risks; 3 – yes, and there are no known significant adverse events)
Thermostability: Are vaccines manufactured using the platform sufficiently thermostable? (1 – no, the vaccine must be stored at -60°C or colder; 2 – no, the vaccine must be stored at -20°C or colder; 3 – yes, the vaccine can be stored at or below 2-8°C or at a higher temperature)
Prototype Availability
Prototype Availability: Is a prototype vaccine available? (1 – no; 2 – yes)
Platform Adaptability
Interchangeability: Is the antigen used in the platform interchangeable? (1 – no or minimal part of structure is intact and replacing the antigen is expected to have a major effect on structure/function relation; 2 – yes, part of the structure is intact and replacing the antigen is expected to have a minor effect on structure/function relation 3 – yes, most of the structure is intact and replacing the antigen is expected to have no effect on structure/function relation)
Process Comparability: For different vaccines manufactured using the same platform, are processes potentially similar for the platform and the non-platform modules? (1 – no, changes are expected, likely major for non-platform modules and minor for platform; 2 – yes, changes are expected though likely minor for both non-platform and platform modules; 3 – yes, changes are expected for non-platform modules).
Analytical Comparability: Can assays that are already validated be used without further development (excluding identity and potency)? (1 – no, major assay development activities are required; 2 – yes, some assay development activities are required, revalidation of some assays is possible; 3 – yes, no assay development is required, revalidation of all assays is possible)
Scope: How many companies and products have used the platform (1 – platform has been used by one company and one product; 2 – platform has been used by one company for 2 or more products; 3 – platform has been used by more than one company for 2 or more products.
Manufacturing Readiness
GMP Compliance: Has the platform been inspected by Regulatory Authorities? (1 – no; 2 – yes, it has been inspected by the NRA in the host country and significant observations have been addressed; 3 – yes, it has been inspected by NRAs in the host and international countries and there were no significant observations, or observations have been addressed)
Technology Transfer: Is the platform sufficiently robust to enable technology transfer? (0 – no; 2 – yes, it has been successfully transferred to one additional facility; 3 – yes, it has been successfully transferred to more than one additional facilities)
Scalability: Is the platform readily scalable for global supply (> 1 billion doses/year)? (1 – no, increasing the scale will require significant development activities; 2 – yes, increasing the scale will require minimal development activities; 3 – yes, increasing the scale will require no development activities)
Shelf-life: Based on the stability and prior knowledge, do vaccines manufactured using the platform have a sufficient shelf-life to support global distribution? (1 – no, the shelf-life is expected to be < 6 months; 2 – yes, there is supportive data that can be leveraged to establish a shelf life of at least 6-12 months, 3 – yes, there is supportive data that can be leveraged to establish a shelf life of > 12 months)
Scores from each of these parameters will be entered into a dashboard (see Table 1) and multiplied to obtain an overall score for each platform to facilitate decision making in a public health emergency, as illustrated in the decision tree in Figure 1.
Questions can be removed if they are not relevant or cannot be answered for all platforms.
Other Considerations
Experience: Which viral families has the platform already been used for?
Access: Does the organization owning the platform support equitable access?
Adjuvant or Delivery System: Is the adjuvant or delivery system for the platform readily available and secured for product life?
Speed: Would the speed of development of a new product based on the platform be likely to meet the 100 Days mission?
GMP Compliance: Which National Regulatory Authorities have inspected the platform?
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