5.5 Platforms

Historically, most medicines, biologics, vaccines and devices were manufactured using unique, one-of-a-kind processes that were developed for each individual product.  In recent years, platform technologies have been used to standardize operations so that they can be used across multiple products to make products with predictable characteristics of safety, efficacy and quality. 

Leveraging platform technologies has great potential to aid in acceleration of the overall product development process.  Principles for use of platforms and platform technologies are provided in the resources listed below: 

• Definitions clarify commonly used terms to facilitate communication among stakeholders

• Categorization provides a line of sight for evolution of a platform toward a state of optimal usefulness during a pandemic based on depth and breadth of experience

• Prior Knowledge facilitates use of data and information from previously validated and approved products to support development of new products using the same platform

• Differentiated Investment summarizes principles that can be used in supporting product development to improve pandemic preparedness and response

• Dashboards for Existing Platforms provide snapshots of the readiness of existing platforms available to enable a rapid response

Country specific guidelines on platforms may be needed to allow flexibility in regulatory requirements based on prior knowledge and experience.