Modular Approach Slashes Biopharm Time-to-Market

G-Con and Caliber Biotherapeutics Go from Breaking Ground to Production in Only a Year

By Walt Boyes

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"Biopharm companies need reductions in capital expenditures, and they need more rapid transitions between product development and commercialization," says Barry Holtz. "They need facilities that start up quickly, are flexible, reusable and expendable with recoverable assets. This is a huge shift from the way things used to be."

Holtz should know. He's CEO of G-Con Manufacturing and chief science and technology officer of Caliber Biotherapeutics. And in his presentation at Rockwell Automation's Process Solutions Users Group (PSUG) meeting this week in Houston, he shared his company's experience in addressing the changing needs of biopharmaceutical companies in general—and his in particular—with the flexibility of Rockwell Automation's PlantPAx process automation system.

Caliber Biotherapeutics participated in a DARPA challenge to design a plant-based biotherapeutics facility that would be hardened, self-sufficient and contained. DARPA said it had to be done in two years. "We, being self-confident Texans," said Holtz, "told them we could do it in a year. Dumbest thing we could have said, but we did it. We started digging holes on April 9, 2009, and were online and making product by March 22, 2010. We grew 2.2 million plants hydroponically and made 300 kg of monoclonal antibody material."

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Holtz explained that the way the company did it was "PODification." We built portable autonomous clean rooms at G-Con and installed them at Caliber. Each of them is an autonomous manufacturing environment that is CFR Part-11 compliant and cGMP5-certified."

Each of the PODs has identical controls, with PlantPAx for the basic process control system. ControlLogix and FactoryTalk are used for building automation and FactoryTalk Pharma Suite at the MES layer. The ControlLogix PLCs provide air handling and onboard fire suppression, as well as control for the grow lights for the millions of nicotiana plants that provide the protein product. Everything is redundant, from the air handlers to the process controls. The historians are built-in and redundant. Even the air bearings that allow a single worker to "walk" a 20,000-pound building into place are redundant. "We built green PODs controlled by PlantPAx to grow our plants in, and we even built our own grow lights."

"We are actually doing Process Analyzer Technology (PAT)," Holtz said, "and we are providing real time data and real time data usage, just like the FDA wants. We have a modern interface for continuous process verification and for continuous process control. We do energy control as part of the containment and classification. We have an easier-to-use human-to-human interface and human-to-machine interface. We could not have done this without Rockwell Automation’s products and our integrator’s skill set using the Rockwell Automation PlantPAx system. I am a big cheerleader for Rockwell Automation."

"We wanted a tool kit for rapid development of smart systems. Rockwell Automation provided that, and we were empowered. We wanted remote monitoring capability, along with remote change-of-algorithm capability, and we got that. We sell our PODs globally, so we needed a service model that was global and that could provide assistance 24/7/365 on a global basis, and we got that too. We wanted a control system that was capable of being iteratively improved, and that we could scale as much as we needed to. We got that from Rockwell Automation also."

"What we have been able to do with PODs, thanks to Rockwell Automation, is to make a significant difference in time to market," Holtz said. "Time to market in the pharma industries can mean millions of dollars. We have built-in quality by design and have worked out the tools to let companies manage their scale-ups faster, better and with less cost than any other way."

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