Officials at GE Healthcare say the company is launching a ready-to-run “factory-in-a-box” to accelerate the production of viral vector–based therapeutics, including viral vector–based vaccines, oncolytic viruses, and cell and gene therapies. The new, prefabricated, and modular KUBio biomanufacturing facility is designed, constructed, assembled, and fully fitted-out to current cGMP standards significantly faster that is required to build a traditional, stick-built manufacturing facility, notes a company spokesperson, adding that this makes it possible to build capacity quickly and easily, allowing drug manufacturers to adapt to market requirements. The factory is also pre-engineered so that it can be expanded at a later stage to offer increased manufacturing output according to the drug demand.
GE’s newest KUBio is designed for products requiring a biosafety level 2 (BSL2) environment such as viral vector–based therapies, but even monoclonal antibody (mAb) and multi-product manufacturers can use the facility. The standard KUBio BSL2 includes a FlexFactory single-use biomanufacturing platform, where the recommended bioreactor size is between 200 and 1,000 liters.
The facility can be extended with a larger, or additional, manufacturing suite according to the market need. As a part of the project, GE provides end-to-end bioprocessing support including manufacturing equipment, a prefabricated modular facility and accompanying suite of services, including installation, financial guidance, project coordination, qualification, and equipment maintenance services, explains Olivier Loeillot, general manager, bioprocess, GE Healthcare Life Sciences.
“The market is moving toward more targeted therapies designed for smaller patient populations. The challenge is that most therapeutics going through clinical trials are not suited for the existing, predominantly large-scale manufacturing infrastructure. Biomanufacturers are looking for fast market entry, lower costs, smaller batches and multiproduct manufacturing flexibility,” says Loeillot. “As the viral vector-based therapies have started entering the market, we are proud to be supporting access for these promising new treatments with flexible manufacturing capacity that is in right scale.”
GE already offers a prefabricated manufacturing solution, KUBio, for the production of mAbs, a FlexFactory biomanufacturing platform for a variety of biologics and, most recently, a scalable FlexFactory platform for cell therapy. Three KUBios and over 40 FlexFactories have already been purchased globally.