Flexible, fast, and modular drug facilities are no longer something of the future, a point driven home by the Interphex 2012 introduction of FlexMoSys—an all-in-one “mobile facility” that includes a GMP-ready cleanroom and biopharma process train. The unit, rolled onto the show floor at the Jacob Javits Center last week, is the result of a joint collaboration between Sartorius Stedim Biotech and G-Con Manufacturing.
FlexMoSys “will play a critical role in the future of biopharma manufacturing,” declared Dennis Powers, Satorius’ North American manager for integrated solutions, who said the genesis for the project happened a few years ago when a Sartorius team visited G-Con and saw first-hand the potential of the self-contained “pods” the company had developed. “Immediately we saw there was a great opportunity in front of us and to start to fundamentally change the way we think about manufacturing and manufacturing processes.”
“Traditional large-scale, purpose-built centrally located facilities are not going to meet the needs of the future,” Powers said, citing the H1N1 scare as a wake-up call to the industry. “As an industry and country we were not adequately prepared to respond to that event. We were fortunate that that particular strain was not as viral as it could have been, but in the future we may not be so lucky.”
What Sartorius had on-site in New York, inside the pod, was an end-to-end single-use cell culture upstream process, including disposable bioreactor, cell culture unit, bag system, touch-panel controller, and more—an entire “presterilized and interconnected” fluid path. “When you’re done with processing, it all gets thrown away,” he said. 50-, 200-, 500-, and 1,000-Liter models will be available. Not shown but also soon available will be similar setups for downstream operations.
“The mobile bioprocessing unit was developed from people who manufacturing drugs,” said Barry Holtz, president and cofounder of G-Con. The idea was: “Let’s just build the coolest cleanroom ever for guys who need to use them every day.”
“We needed a disruptive technology,” he added, one that was self-contained (e.g., its own air handlers, filtration systems, and controllers) and redundant—two of everything—so “you can do maintenance on one while running the other.”
The pod is designed to be moved or shipped anywhere, and “used and used again for any purpose,” said Holtz. “We can deliver these to you in 15 weeks . . . you buy this like you buy a piece of equipment.”
“The vision for us is that at one point our clients will be able to order this unit with just an item number,” added Maik Jornitz, Global Marketing Director for Sartorius. “You get the entire unit shipped to you and you can put them together like lego blocks.”
It remains to be see to what degree biopharma manufacturers will buy in, but, Holtz claims, regulators are behind the concept. G-Con and Sartorius presented various pod concepts to FDA. “We had nine people from CDER and CBER in same room, and basically they said, ‘We get it. It’s a cleanroom. Hit your marks.’”
A brochure with specifics on FlexMoSys is available here.