Due to the current COVID-19 pandemic there is tremendous pressure on biopharmaceutical companies to rapidly develop vaccines and therapeutics which can help bring the pandemic under control. As a result, companies are forced to find ways to significantly shorten the development timeline.
Platform technologies have historically been established within the biopharmaceutical industry to accelerate development. These approaches rely on using defined strategies for candidate selection, followed by an array of process and product development activities. These activities are performed according to a well-defined framework that has been specifically established for the target modality, based on prior knowledge and experience. In addition, successful implementation of a platform approach requires the availability of a set of robust analytical methods capable of reliably monitoring the relevant CQAs of different development candidates within a modality class, thus requiring minimal development and simplifying qualification and/or validation efforts. Finally, end to end coordination and alignment across the various groups involved in the development cycle, a robust IT infrastructure, and consistent equipment and facility design are critical to enable rapid development and avoid delays. To date, several companies have been able to significantly shorten the development timeline for vaccines and therapeutics through the use of platform technologies. As a result, a diverse array of candidates are progressing through the development pipeline, ranging from Adenovirus, AAV, mRNA and protein-based vaccines, to mAb based therapeutics, indicating that platform approaches are generally applicable.
The lessons learned and advantages of using platform technologies to expedite development and regulatory submission of new vaccines and therapeutics will be shared and discussed. Topics will include:
• Are certain modalities better suited to develop into a technology platform (Adenovirus, AAV, mRNA, protein vaccines, protein therapeutics)? • The use of platform analytical methods in development and commercial QC • How to ensure coordination between the various CMC activities to minimize bottlenecks and transition delays • Does efficient data capture and data mining accelerate development? • Impact of facility design on the ability to efficiently leverage platform development approaches • Regulatory expectations for submissions relying on platform knowledge • What are we learning from the use of platform technologies for highly accelerated development: are there opportunities to improve our post-pandemic ways of working?