The construction of the disposables-based facility, known as KUBio, offers a new approach to biopharmaceutical manufacturing because GE can deliver a functional, ready-to-run bioprocessing facility in a shortened timespan of between 14 and 18 months when compared with the regular timeframe for building a facility.
Olivier Loeillot, general manager of enterprise solutions at GE Healthcare Life Sciences, told BioPharma-Reporter.com that the pre-designed facility is actually built in Germany under cGMP specifications, and then GE assembles it at the site in the Biolake Science Park in Wuhan, China.
The site for the new factory is expected to be fully operational by early 2015.
In addition to GE project-managing the construction, members of its Shanghai Fast Trak team will be deployed to validate the equipment and provide training for JHL Biotech staff.
After completion, the JHL Biotech facility will have a floor space of approximately 2,400m2 and will contain four 2,000L single-use bioreactors, Loeillot said.
He also told us that the facility will be able to produce mAbs (monoclonal antibodies), mostly for use in cancer treatments.
Trend of Single-Use in Emerging Markets
The design concept of KUBio reflects in part a wider movement in China and other emerging markets such as India and Brazil, which are looking to establish local manufacturing capacity, Loeillot said, noting that GE has a “rich pipeline of projects over the next few years.”
He explained the ease with which these facilities can be set up will transform the way emerging markets can expand their local manufacturing and deal with growing cancer and diabetes rates.
“Biopharmaceutical companies are switching at a fast pace to disposables-based facilities because of the way they can entirely eliminate the prospect of contamination and cleaning, which can be more difficult with less experienced professionals.
“The advantage of being able to switch between products quickly is also one of the major benefits of disposable bioreactors,” Loeillot added.
As far as the environmental concerns of single-use, which Loeillot said he’s received a lot of questions on, there is actually more of an upside than downside, he added.
Reductions in water consumption from the elimination of cleaning as well as decreases in electricity have made disposable biopharma tech eco-friendly. But he also acknowledged that the disposable bioreactors have to be disposed of properly.