Tech Transfer of a commercial scale USP process:
the start-up of Janssen’s Vaccines Launch Facility
Lodewijk de Jonge [1], Douglas Kennedy [2], Dirk-Jan Bulstra [3]
[1] ldejonge@its.jnj.com, Janssen Vaccines & Prevention B.V., [2] Janssen Research & Development,[3] Janssen Biologics B.V.
The platform Upstream Process (USP) for production of Adenovirus-based vaccines at Janssen Vaccines is a perfusion-based PER.C6®-based cell culture process. This process has been used successfully at pilot scale for production of early clinical trial material for our different vaccine development programs for many years now. As some of these projects are now moving into late stage development, the USP platform process has been scaled-up to obtain a process that generates the desired product quality at a commercial volume and acceptable costs of goods. Also, a brand new GMP facility was constructed between 2015 and 2017 in Leiden (the Vaccines Launch Facility) in which the scaled-up process can be run for production of phase 3 clinical material and commercial launch. A series of engineering runs was completed successfully in 2018, and the facility will now start GMP production. This presentation will highlight some of the scale-up challenges specific to our high-cell density perfusion process, as well as results of the Tech Transfer of the scaled-up process into the new facility.
