GE, best known for making lightbulbs and jet engines, is launching its KUBio factory-in-a-box prefab line of drug manufacturing units that will help biopharma companies produce viral vector-based vaccines, oncolytic viruses, and gene and cell therapies.
The modular KUBio biomanufacturing facility is designed, constructed, assembled and fully fitted-out to current good manufacturing practice standards much quicker than the time it usually takes to build a traditional manufacturing facility.
A GE spokeswoman told Reuters that the company is currently in talks with several potential customers for the new off-the-shelf viral vector factories. The company is also ramping up its supply chain operations needed to deliver cell therapies like Novartis’ Kymriah and Gilead Sciences’ Yescarta, both of which were approved in 2017 for treating certain blood cancers.
Currently, there are more than 700 viral vector-based therapies in clinical trials, driving demand for biologically secure bioreactors to manufacture these products. The prefab process can trim about 45% from a biopharma project's costs, which can be upward of $500 million.
“The market is moving toward more targeted therapies designed for smaller patient populations,” Olivier Loeillot, general manager, BioProcess, GE Healthcare Life Sciences, said in a statement. “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.”
Modular drugmaking facilities that can be assembled more quickly and easily to meet very local needs have been on drugmakers' wish lists for some time. In 2015, Pfizer announced it and GlaxoSmithKline agreed to a multiyear collaboration for the next-gen design of its portable, continuous, miniature and modular (PCMM) prototype for oral solid-dose production.