Aug. 16, 2017

Screen Shot 2017-08-16 at 9.08.28 AM

Courtesy of The Eagle: Fujifilm biotech firm teaming with Texas A&M to keep U.S. healthy

The next time an infectious virus or disease emerges in the U.S., local partners in College Station could be part of the solution as medical professionals race to address the threat.

The Texas A&M University System and Fujifilm Diosynth Biotechnologies Texas are nearing the next phase of a partnership with the federal government as a Center for Innovation in Advanced Development and Manufacturing. The private company recently moved in to its new facility, which officials said stands ready to develop vaccines and other medical countermeasures to help keep Americans safe and healthy.

The company and its facilities are the manufacturing arm of the Center for Innovation in Advanced Development and Manufacturing at the A&M System -- one of three such centers established by the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) project for the purpose of developing and manufacturing medical countermeasures, such as vaccines and therapeutics used to protect health in emergencies ranging from an influenza pandemic to potential bioterrorism.

 

The contract is not to exceed $285 million, $176 million of which is covered by federal grants over the initial five-year period, officials said. The remaining amount -- largely used to construct, equip and provide infrastructure for the facility -- is covered by the private manufacturing partner, who will continue to fund operations for the facilities. Additionally, the State of Texas Emerging Technology Fund contributes $40 million, officials said.

In between its responsibilities tied to the federal response program alongside the A&M System, Fujifilm Diosynth Biotechnologies' private business operations focus on offering services from development to manufacturing to companies in the biopharmaceutical industry.

The company also operates sites in North Carolina and the United Kingdom.

'Only show in town'

Gerry Farrell, chief operating officer of Fujifilm Diosynth Biotechnologies Texas, said the company is able to take its clients' work from the pre-clinical phase all the way through manufacturing and production.

Farrell said the company often works with highly complex molecular compounds on behalf of its clients. As a comparison, he said if a common drug such as aspirin is a 20-pound bicycle, some of the large biologic molecules the company works with would be a 30,000-pound passenger plane.

The company currently employs 136 people -- roughly 30 of whom have been hired since March -- and is expected to expand to about 150 by January. Farrell said after that, he expects to see continued growth alongside business operations.

To help keep the workforce properly trained and allow for the hiring of local employees, the company is partnering with Blinn College on a number of workforce training programs.

The pair of institutions jointly have been awarded a nearly $300,000 grant from the Texas Workforce Commission to provide training in more than a dozen areas, including business computing, Occupational Safety & Health Administration certifications, powered industrial truck operators and more. Altogether, the union is expected to provide training resources for 34 upgraded positions and 106 new jobs.

Farrell said while the company is bringing in employees with prior experience in the "highly technical positions" from around the country, it also "want[s] to recruit locally as well, so if you can't get the trained staff, then we have to train them ourselves.

"In a sense, we're the only show in town when it comes to what we're doing," Farrell said.

While the company has and will continue to operate out of A&M's National Center for Therapeutic Manufacturing in College Station, its nearly operational biomanufacturing facilities located near Easterwood Airport and The Stella Hotel is expected to be working on products by the end of the year. The two adjacent facilities have a combined space of nearly 200,000 square feet.

Farrell said the company has invested $93 million in the College Station facilities thus far, with plans for an additional $28 million that could be invested in equipment in the future.

Texas A&M System: '50 percent profit'

In December 2014, Fujifilm Diosynth Biotechnologies inked a deal to acquire 49 percent of A&M System-started Kalon Biotherapeutics -- a private drug development company formed in 2011 to develop vaccines for the Center for Innovation in Advanced Development and Manufacturing at A&M.

The announcement of the deal drew national attention and the attendance of then-Gov. Rick Perry for a ceremonial closing of the acquisition at the George H.W. Bush Presidential Center.

Laylan Copelin, vice chancellor of marketing and communications at the A&M System, said officials knew early on there would be a need for a larger, more experienced manufacturing partner to be brought in to replace Kalon.

At the time of the announcement, a state spokesperson said the A&M System would receive between two and five times its original $2.5 million investment in starting Kalon. Copelin said the A&M System made a 50 percent profit on its stake in Kalon.

Under the agreement, Fujifilm Diosynth Biotechnologies took 100 percent ownership of the company in March after completing a series of previously agreed upon objectives, including the completion of the pair of biomanufacturing vaccine facilities in west College Station.

Although the Tokyo-based Fujifilm traditionally has been best known in the camera industry, Farrell said it has been making the transition into the life sciences field in recent years. The company acquired Diosynth Biotechnologies in 2011.

As the opportunities in the partnership expanded, he said there was a need for a commercial partner that had the financial backing to be able to meet the monetary obligations outlined in the agreement.

Farrell said the opportunity to participate with the Biomedical Advanced Research and Development Authority on the federal level and Center for Innovation in Advanced Development and Manufacturing at A&M was a big part of the draw for the company when it was making the decision to purchase Kalon.

"We brought our commercial manufacturing and development experience, and the technologies were here for us to take up and to partner with the government and the university on those other products," Farrell said.

Additionally, he said it afforded the company the ability to expand its business into new areas.

"What was here was an offering we didn't have at the other sites," Farrell said. "The other sites are solely microbial fermentation and cell culture manufacturing. Here, there was an opportunity to get into vaccine manufacturing [and] gene therapy."

Copelin said the first 5 1/2-year phase of the contract was focused on constructing, equipping and establishing the infrastructure of the center's facilities.

Moving forward, the A&M System will remain involved in the federal BARDA partnership and will act as a project manager of sorts should the Center for Innovation in Advanced Development and Manufacturing be called upon to respond to potential health emergencies. Fujifilm Diosynth Biotechnologies Texas, like Kalon before it, serves as the manufacturing partner for the team.

Copelin said now that the facilities are nearly fully operational, the partnership will spend the next 20 years responding to the U.S. government's requests for "various products and whatever needs they have."

Although not a part of the federal contract, Copelin said the private partners in these agreements are encouraged to use the facilities for their private work to ensure the facilities and workforce are always operational and ready to respond to whatever situation may arise.

"By design of the federal government, the partners have the ability to use the facilities to do warm basing -- keep operations going and your workforce humming," he said. "If you can make other products or do other projects, there are boundaries around that, but they (want them) to do that. They don't want [the facilities] moth-balled with people sitting around until the next virus pops up."

For the A&M System, Copelin said its role with the Center for Innovation in Advanced Development and Manufacturing is viewed as more of a service to the country than anything else.

"We did what we were supposed to do in the first five years of the contract, we've delivered and transferred the facilities to a contract manufacturing organization in [Fujifilm Diosynth Biotechnologies Texas]," Copelin said. "… We stand ready for when the federal government tells us what they need."

For more on the Center for Innovation in Advanced Development and Manufacturing partnership, go to www.medicalcountermeasures.gov/barda/core-services/ciadm.aspx.

grey-arrow-right grey-arrow-left