KBI, which JSR acquired in 2015, opened a laboratory in Belgium in 2018. The Leuven site provides analytical testing services but KBI’s European operation lacks the molecule production capabilities it offers in the US.
That is set to change. By mid-2022, KBI expects to have a 5,600-square-meter biologic bulk drug substance manufacturing facility up and running in Geneva, creating more than 200 technical positions in development, operations, and quality assurance in the process.
The decision to add drug manufacturing capacity in Switzerland was underpinned by feedback from European customers.
“There’s nothing like a collection of clients saying, ‘we’d really like to do this work closer to home.’ A number of our European customers have expressed an interest. So, as we fill out our factories and look at adding capacity, it was the natural decision for us to look at expanding in Europe,” Tim Lowery, president at JSR, told this publication.
The Geneva facility will house two 2,000L single-use cGMP manufacturing trains, plus infrastructure for performing quality control testing for release and in-process testing. KBI will continue to carry out cGMP testing of drug substance and drug product stability at its facility in Belgium.
Cell-line development
KBI will be joined at the Geneva site by Selexis, a cell line development and gene technology player that JSR acquired in 2017. The takeover was motivated by a belief Selexis’ cell-line generation assets complement KBI’s manufacturing capabilities. Co-locating Selexis and KBI in Geneva positions JSR to realize the benefits of more tightly integrating the capabilities of the two companies.
“By having those two companies collaborate together ... the probability of a given project being ... successful at a faster pace is greatly increased,” Lowery said. Using Selexis for cell-line development and KBI for manufacturing can halve the typical timeline, according to Lowery, but customers can choose to work with just one of the JSR companies.
Selexis’ existing headquarters is in Geneva but the new facility represents a significant step up on its current operation. When the new site comes online around the middle of next year, it will increase Selexis’ footprint in Geneva by 200%.
The site will house standard cell line development suites, plus two separate cell culture suites for quarantined client-specific cell lines or client-dedicated cell line spaces. The floorplan and design of the facility support department-wide segregation and the use of monitoring systems.
Lowery said JSR is working on other, as-yet-undisclosed investments and continues to monitor the development of technologies that support the production and purification of the complex molecules that make up the global biologics pipeline.