BTEC assists Medicago-USA with facility start-up

When a company wants to commission a new multi-million dollar vaccine manufacturing facility, it needs time, money, state-of-the-art technology, trained personnel, and a few good friends. When Medicago-USA, a wholly owned subsidiary of Medicago, Inc. (Québec, Canada), began start-up activities in its new RTP facility, it found itself still waiting for the delivery of a critical piece of upstream equipment and short on testing resources. After a few calls to the Golden LEAF Biomanufacturing Training and Education Center (BTEC), management had found a way to outsource upstream operations, start testing their downstream processes, and analyze environmental samples to verify the building’s functionality. Since those initial calls, BTEC has executed several service contracts with Medicago-USA, and in April 2012, the firm was able to successfully complete a key milestone by producing more than 10 million doses of vaccine in one month. By turning to BTEC to meet its needs, the company estimates that it was able achieve this important milestone about three months earlier than if it had waited for the necessary resources to arrive.

Medicago-USA initiated construction of its new 97,000-square-foot facility after signing a $21 million Technology Investment Agreement with the Defense Advanced Research Projects Agency (DARPA) in August 2010. The facility was designed to produce 30 million doses of quadrivalent seasonal influenza vaccine or 120 million doses of pandemic influenza vaccines, if needed. By September 2011, most of the construction was complete. A state-of-the-art greenhouse was ready to grow the tobacco plants used in the production of the vaccine, and equipment was on hand to purify the active ingredient for the vaccine. But Medicago-USA still had no bioreactor to provide the optimal conditions for growing the Agrobacterium bacteria that supply the genetic material to the tobacco plants. The plants use this material to produce virus-like particles (VLPs), which, when administered to humans, elicit an immune response that prevents influenza. Likewise, personnel and equipment were not in place to analyze hundreds of samples taken to ensure that the clean utilities and environments were operating as designed.

30 L and 300 L bioreactors in a BTEC lab

Bioreactors used to produce Agrobacterium bacteria for Medicago-USA

BTEC, a multidisciplinary training center on Centennial Campus that offers courses to both university students and industry employees, also utilizes its facilities, equipment, and staff to help companies that need temporary resources. Through the work of its talented operations staff, many of whom were previously employed in the biomanufacturing industry, BTEC provided several batches of bacteria to Medicago-USA while the company waited to receive and commission its new bioreactor. It also helped generate cell mass from an alternate strain for evaluation purposes. Medicago-USA was able to continue producing its lead bacteria without having to modify its entire fermentation schedule to produce the extra cell mass. Without this critical resource, Medicago-USA would have been unable to confirm its production process was successfully scaled-up and transferred from its Québec facility. In addition to the fermentation batches, BTEC provided access to some specialized purification equipment so that Medicago-USA could evaluate it before investing in a purchase. BTEC also provided analytical support by testing samples from water systems, critical utilities, and cleaning qualification studies for microbial and chemical contamination. Medicago-USA found the BTEC microbiology and biochemical analytical resources to be of great value in supplementing its in-house testing capability.

The two organizations remain good partners. Medicago-USA plans to further develop its relationship with BTEC, which it considers to be a flexible partner that provides a wide variety of bioprocess options. Medicago-USA can take advantage of these services to supplement its bioprocess and analytical development needs. Due to BTEC’s history of scheduling and completing projects, contracts are approved and initiated in a matter of days versus weeks. Medicago-USA has since hired NC State graduates who have taken BTEC courses, and the company has found them to be well prepared, eager to learn, and valuable assets to its organization. The company continues down the path towards approval to manufacture and distribute its influenza vaccine. BTEC continues to offer training and conduct process development projects to a diverse group of organizations according to testing services and sponsored project agreements. Local companies find BTEC to be a convenient and valuable resource, and prospective biotechnology companies considering North Carolina as a home are also attracted to BTEC’s capabilities.

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Medicago USA