First prefab biologics plant goes up in China, in 11 days

A rendering of GE Healthcare's KUBio modular biopharmaceutical factory--Courtesy of GE

Call it a biopharma plant in a box--62 boxes actually. That is how many containers were shipped from a GE ($GE) production facility to China to build GE's first prefab biologics plant for JHL Biotech, a company founded by U.S. biotech veterans working on biosimilars.

The plant, which was assembled at the JHL site in Wuhan in only 11 days, is the product of GE's attempt to bring mass-production techniques, and lower costs, to something that has traditionally been a custom-designed and very expensive process. GE had already completed installation of its biomanufacturing platform at JHL Biotech's Research Center and manufacturing plant in Hsinchu, Taiwan.

"It's one single manufacturing concept that we can replicate around the world," Olivier Loeillot, GE Healthcare Life Sciences' Asia general manager told Bloomberg. "As the pharmaceutical industry goes from big-volume blockbuster drugs to tailored, smaller-scale drug manufacturing we want to meet that demand."

Loeillot told the news service that the prefab process can trim about 45% from a biopharma project's costs, which can be upward of $500 million. He said the clean rooms, piping and HVAC, even the toilets, are installed at the GE production plant in Germany. He likened assembly to working with LEGO blocks. Using disposable bioreactors instead of stainless steel will cut operating costs as well.

GE said companies can use them to create a new plant or to add to an existing facility. The first two plants went up in China for JHL, but GE has had interest from companies wanting to build them in other developing markets like Turkey and Brazil that want more specialized biologics.

Modular drugmaking facilities that can be erected more quickly and easily to meet very local needs has been something that drugmakers have been working toward for some time. Just last week, Pfizer announced that it and GlaxoSmithKline ($GSK) have agreed to a multiyear collaboration for the next-gen design of its portable, continuous, miniature and modular (PCMM) prototype for oral solid-dose production. Pfizer describes the PCMM as an autonomous and transportable pod that may be quickly shipped from location to location and readily brought online to create a fully functional module that meets GMP standards. Using continuous manufacturing processes means smaller plants and lower costs.

CEO Racho Jordanov told Bloomberg the prefab route made sense for JHL and that the company picked China for the plant in part because manufacturing costs there are cheaper, but that the plant is designed to meet FDA and EMA GMP standards. Jordanov, who spent two decades at Genentech, said that the prebuilt facility takes some of the uncertainty out of building its first facility in China.

"If I was building the same thing in San Francisco, I would totally build it myself but with this, I'm not going to take any chances," Jordanov said. "With this option, even if an inspector was blindfolded and put on airplane--if they walk into our plants they wouldn't be able to tell if she was in Basel, Switzerland or Wuhan, China."

- read the Bloomberg story