GE’s new factory-in-a-box for viral vector based therapeutics. Credit: General Electric.

GE Healthcare has created a ‘factory-in-a-box’ facility for the production of viral vector-based drugs, including viral vector vaccines, oncolytic viruses, and gene and cell therapies.

The prefabricated and modular KUBio biomanufacturing facility is designed, constructed, assembled and fully fitted to current good manufacturing practice standards in significantly less than time than it takes to build a traditional manufacturing facility.

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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.

While the factory is designed for biosafety level 2 medicines, including viral vector drugs, it can also be used for monoclonal antibody (mAb) and multi-product therapeutics.

The company will offer end-to-end bioprocessing support, including supplying manufacturing equipment, a prefabricated facility and accompanying services such as installation, financial guidance and equipment maintenance.

“The challenge is that most therapeutics going through clinical trials are not suited for the existing, predominantly large-scale manufacturing infrastructure.”

GE Healthcare Life Sciences bioprocess general manager Olivier Loeillot said: “The challenge is that most therapeutics going through clinical trials are not suited for the existing, predominantly large-scale manufacturing infrastructure.

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“Biomanufacturers are looking for fast market entry, lower costs, smaller batches and multiproduct manufacturing flexibility.”

Viral vectors are modified viruses designed to deliver genetic material to target cells to treat certain diseases. More than 700 viral vector-based drugs are currently being tested in clinical trials.

GE already offers a prefabricated manufacturing solution 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.