Just-Evotec Biologics, a subsidiary of Evotec, is investing in a new facility for continuous biomanufacturing. Nick Hutchinson, Head of Market Development, Just-Evotec Biologics, Evotec, provided an update at the DCAT Member Company Announcement Forum held on March 18th, 2024, at DCAT Week. 

Just-Evotec Biologics is constructing a new biomanufacturing facility in Toulouse, France. The facility applies the company’s J.POD design featuring a single-use continuous cell-culture manufacturing platform set inside production-on-demand modules within a ballroom manufacturing space. In this way it replicates the design of the company’s J.POD facility in Redmond, Washington.

The investment of approximately EUR 150 million ($163 million) was announced in April 2021, and the company broke ground on the project in September 2022. In October last year (2023), the building shell was completed, and the autonomous cleanroom POD installation occurred at the beginning of this year (2024). The equipment will now be installed into the cleanroom PODs ready for the facility to be operational by the second half of 2024.

The facility will contain two continuous cell-culture manufacturing streams. Each stream has an option for either a 500-L or 1000-L bioreactor. J.POD Toulouse will manufacture both clinical and commercial material and can produce up to 2000 kg of antibody each year.

At the core of the project is the end-to-end fully continuous manufacturing platform for antibodies and other therapeutic proteins with an Fc-region. The platform is entirely made up of single-use processing technologies. The bioreactors will be operated in a perfusion mode and fitted with hollow fiber cell retention filters. The perfusate will be loaded onto multi-column capture chromatography steps while subsequent polishing steps are operated in a flow-through mode. There is continuous purification of the product stream from the capture step through to the final single-pass concentration and diafiltration step prior to bulk fill. J.POD Toulouse will contain five PODs in the first instance for cell expansion, cell culture through purification, and virus-negative suites.

The site will be equipped with technologies to support successful manufacturing operations. These include the Solentim VIPS system for creating and proving the monoclonality of genetically modified cell lines that are the most essential raw materials for running a process. The company has already installed high-throughput automation and robotics into its supporting laboratory infrastructure to allow the screening of processing conditions that deliver the necessary productivity along with the required purity required of biological medicines. These conditions will be tested and scaled-up in 3-L bioreactors and bench-scale chromatography systems. Process development activities are informed by high-throughput platform analytical methods, impurity methods for DNA, host-cell proteins and residual Protein A analysis, functional biocharacterization methods, and mass spectrometry, including multi-attribute LC-MS/MS methods.