Vibalogics will provide clinical trial material for J&J’s COVID-19 vaccine candidate from its site in Cuxhaven, Germany. J&J is also working with Catalent and Emergent.
Johnson & Johnson (J&J) began working on a vaccine against COVID-19 in early January once the coronavirus sequence became first available, and at the end of March identified the lead its lead candidate along with two backups.
Since then, the firm has worked on ensuring production of clinical and – potentially – commercial supply, with a pledge to produce one billion doses by the end of 2021.
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To help facilitate this, J&J has procured the services of German contract development and manufacturing organization (CDMO) Vibalogics, which will manufacture clinical trial material for the lead candidate from its site in Cuxhaven, Germany, about 50km west of Hamburg.
Stefan Beyer, the CEO of Vibaologics told us “this is a significant project for Vibalogics,” consisting of making multiple batches of the vaccine, resulting in many thousands of doses. Specifics have not been divulged, but Beyer said his firm has been able to adapt its capacity “so that no other ongoing projects will be impacted.”
J&J’s own capabilities in Pennsylvania, US and Leiden, The Netherlands are being used and expanded to support the COVID project. Concurrently, the firm has secured drug substance manufacturing services – including the reservation of large-scale manufacturing capacity – at CDMO Emergent Biosolutions’ sites in Maryland, while Catalent has also been brought abroad to provide fill and finishing services from its site in Bloomington, Indiana.
Vibalogics expansions
The Cuxhaven site completed a $1.35 million expansion in 2019, adding a manufacturing line consisting of a 50 L and 200 L single-use bioreactors and a Siemens process control system. The line is capable of filling and labelling more than 30,000 vials per batch.
Private equity firm Ampersand Capital Partners’ acquisition of the CDMO last year led to further planned expansion at the site, though Beyer told us that none of them are directly linked to this project.
Meanwhile, the CDMO is looking to build up its network across the pond.
“We are investing in new large-scale capacity that provides process development through to late-stage and commercial manufacturing,” Beyer said. “Our US expansion would encompass 500 and 2,000 L Single Use Bioreactors as well as a filling unit. The expansion will be operational in the near future.”