FermWorksAccelerating the Commercialization of New Bio-therapeutics “We’ve expanded our FermWorks operation because it helps us be efficient in the development laboratory. FermWorks is helping us with process development that is focused on commercialization of the product.” Steve Hawley Sr. Director of Drug Substance Development NexBio, Inc. NexBio, a biopharmaceutical company in San Diego, California, is creating and commercializing novel, broad-spectrum biopharmaceuticals to prevent and treat current and emerging life-threatening human viral diseases. The Challenge NexBio has multiple R&D programs focusing on influenza and other infectious diseases, all supported by the NIH. With product in early clinical trials, NexBio was ready to optimize processes to increase yield and support more advanced clinical development. Additional equipment was needed to increase the pace of process development. The Solution In early 2008, NexBio expanded their lab, adding two bioreactors, pumps and balances, and upgrading to a networked installation of FermWorks. To make best use of their funding, they bought pre- owned bioreactors The results The move from the single-station to the networked version of FermWorks expanded NexBio’s capability by providing viewing and management of multiple bioreactors from all of the networked computers. The additional instrumentation enhanced process analytical capability while the FermWorks software unified fermentation data management. The Challenge NexBio, Inc. a San Diego, California based biopharmaceutical company is developing broad-spectrum therapeutic and prophylactic agents to protect the public from all annual and pandemic variations of influenza and other life-threatening respiratory viral infections. NexBio currently has multiple R&D programs focusing on influenza and other infectious diseases, all supported by the NIH. “The threat of a potential influenza pandemic and the possibility of viral resistance to current antiviral drugs add urgency to our development efforts,” said Stephen Hawley, Sr. Director, Drug Substance Development. “We are working on increasing yield and optimizing processes to support more advanced clinical development and lower the cost of goods of this important drug,” he said. To sustain corporate growth and expand its critically important product pipeline, NexBio needed to expand lab capacity. The Solution NexBio began working with FermWorks in 2005 with just one bioreactor managed by a single computer. They selected FermWorks with future lab expansion in mind, knowing that FermWorks would be able to support bioreactors and instruments from various manufacturers – keeping their hardware purchase costs at a minimum and providing a single type of control and user interface for multiple brands and types of lab equipment, as well as offline (manually-entered) data. “One of the reasons we initially went with FermWorks three years ago, was that FermWorks would allow us to grow and add new instruments in our lab. We are able to utilize a variety of hardware products without retraining staff on new software interfaces,” Hawley said. In early 2008, NexBio was able to expand the lab, adding two bioreactors, ancillary pumps and balances. Upgrading to a networked installation of FermWorks resulted in a cost-effective expansion. The move from the single-station to the networked version of FermWorks expanded NexBio’s capability by providing viewing and management of multiple bioreactors from all of the networked computers including remote stations. “With FermWorks, we are able to extend our equipment dollars by buying older hardware, while still being able to run experiments with up-to-date FermWorks software,” Hawley said. “FermWorks lets us set up the software to control instruments as needed.” FermWorks gives NexBio a comprehensive software solution for distributed process control and data management of all of the “open” instruments in their development and pilot laboratories. FermWorks’ networked supervisory process control aggregates and integrates the information from the labs’ bioreactors, other on-line instruments, and from off-line sources. In addition, FermWorks automatically monitors and controls processes based on parameters set by the NexBio research scientists. The FermWorks software works cooperatively with (or without) hardware controllers from any vendor. The Results As a result, NexBio has been able to expand their lab to meet their growing requirements. “We’ve expanded our FermWorks implementation because it helps us be efficient in the development laboratory.” said Stephen Hawley, Sr. Director Drug Substance Development. “FermWorks is helping us with process development that is focused on commercialization of the product.” “Of critical importance has been FermWorks’ flexibility in operating fermenters in a development environment. This is the main strength of FermWorks. It allows us control over fermenter operation and data logging capabilities,” Hawley continued. “Ultimately, FermWorks provides good value for laboratory operations. On top of this, we get great support from Jova Solutions. When we have questions, we call and get answers,” Hawley concluded.