Leveraging prior knowledge during vaccine development has great promise for acceleration of the overall process from immunogen design through non-clinical and clinical testing, manufacturing and registration.
A common understanding of definitions related to platform technologies is foundational to clear communication. Concise definitions for commonly used terms related to platform technologies are provided below. Figure 1 and Table 1 are provided to help enhance understanding the differences among some of these terms.
Definitions
Designated Platform
A platform that meets the following eligibility factors for granting the designation: (1) it is incorporated in, or used by, a product that is authorized by a WHO Listed Authority (WLA); (2) preliminary evidence demonstrates that the platform has the potential to be incorporated in, or used by, more than one vaccine without an adverse effect on quality, manufacturing, or safety; and (3) data or information indicates that incorporation or use of the platform has a reasonable likelihood to bring significant efficiencies to the vaccine development or manufacturing process and to the regulatory review process.1
Established Platform
Designated platform that has been demonstrated in two or more productsthrough validation, authorization by at least one WLA, and use.
Modality
‘Modality’ refers to the structure of a product’s active substance. Examples of modalities are mRNA, protein subunits and Viral Vectors.
Platform
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. Examples of platforms are Moderna’s mRNA platform for COVID-19 that was used for developing RSV, the Novavax nanoparticle protein subunit platform for COVID-19, and the Oxford ChAdOx1 viral vector platform for COVID-19.
Platform Technologies
‘Platform Technologies’ are well-understood, reproducible and antigen agnostic technologies, which can include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, specific process (e.g. fermentation or purification), analytics or a combination of any such technologies that the sponsor demonstrates (1) is incorporated in or used by a product and is essential to the structure or function of such product; (2) can be adapted for, incorporated into, or used by, more than one product sharing common procedural elements; and (3) facilitates the manufacture or development of more than one product through a standardized production or manufacturing process or processes.1
Potential Platform
Manufacturing process, specifications, equipment and Quality Management System that uses platform technologies and can potentially be usedfor the manufacture of more than one product through a standardized process but has not yet been validated, licensed by a WHO Listed Authority and used.
Product
Biological, pharmaceutical, vaccine, diagnostic or device to benefit healthcare.
Prior Knowledge
‘Prior Knowledge’ includes knowledge from development and manufacturing experience (e.g. experience based on similar products and processes) as well as reference to scientific and technical publications of established scientific principles.
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