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The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.
On April 17, 2018, GE Healthcare announced the launch of a “ready-to-run factory-in-a-box” that aims to speed up production of viral vector-based therapeutics, including viral vector-based vaccines, oncolytic viruses, and gene and cell therapies.
The company reports that the new, prefabricated and modular KUBio biomanufacturing facility is designed, constructed, assembled, and fully fitted-out to cGMP standards in a significantly faster amount of time compared to a traditional, stick-built manufacturing facility. The speed with which this new facility can be completed enables capacity to be built quickly and easily, allowing drug manufacturers to adapt to market requirements, as stated by the company.
The factory is also pre-engineered to be expanded at a later stage to offer increased manufacturing output according to the drug demand, the company reports.
The company’s newest KUBio is designed for products requiring a biosafety level 2 (BSL2) environment, such as viral vector-based therapies, however, monoclonal antibody (mAb) and multi-product manufacturers can also use the facility. The standard KUBio BSL2 includes a FlexFactory single-use biomanufacturing platform, for which a bioreactor size between 200 L and 1000 L is recommended. The facility can be extended with a larger, or additional, manufacturing suite according market need.
As part of the project, GE provides end-to-end bioprocessing support, including manufacturing equipment, a prefabricated modular facility, and accompanying suite of services. Services include installation, financial guidance, project coordination, qualification, and equipment maintenance services.
“The market is moving towards 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,” said Olivier Loeillot, general manager, BioProcess, GE Healthcare Life Sciences, in a company press release.
“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,” Loeillot added.
Commercial viral vector therapies started appearing in mid-2000 and have since grown in popularity due to their platform approach and advancements in cell engineering, the company reports. Currently, more than 700 viral vector-based therapies are in clinical trials, and several treatments have already received a market approval, as stated by the company.
Viral vectors are modified viruses that are being used as vehicles to deliver genetic material into target cells. They protect the new gene from degradation while delivering it to the target cells that start using the new genetic code to cure or treat a certain disease, according to the company.
GE already offers 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. The company reports that three KUBios and more than 40 FlexFactories have been purchased globally to date.
Source: GE Healthcare