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?

Tamer Eris

Amgen Inc.

Appearances