Pennsylvania Governor Tom Wolf announced plans for the expansion of USSF on Dec. 3.

A pharmaceutical manufacturing company will be expanding its operations in the Lehigh Valley to accommodate its work in developing a COVID-19 vaccine. The expansion project will create and retain more than 100 total jobs in the region.

U.S. Specialty Formulations (USSF) is expanding its 41,000 square-foot Allentown facility and investing $5.2 million into the project, creating 97 new high-paying jobs in the Lehigh Valley and retaining 14 more, according to the company.

“USSF’s expansion means so much for Lehigh Valley – bringing new, good-paying manufacturing jobs to the area – but also for Pennsylvania as a whole,” said Pennsylvania Gov. Tom Wolf, who first announced the expansion on Dec. 3.

“There will be a global demand for COVID-19 vaccines, and investments like this can help position our commonwealth for success in recovery from this pandemic,” Wolf said. “My administration is eager to support the growth and success of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe.”

USSF, working in partnership with VaxForm LLC, expects to be granted an emergency use authorization approval from the U.S. Food and Drug Administration to release a COVID-19 oral and injectable vaccine in mid-2021, according to the company.

To meet its schedule, USSF must make renovations, acquire equipment, and hire new employees. USSF will be providing clinical materials from its Allentown plant for the human phase one clinical safety trials scheduled to begin in January.

“Completion of the USSF expansion will add a significant capability and capacity for our oral Vaccine Platforms,” said USSF CEO Dr. Kyle Flanigan. “As we continue the ramp for our Generation 1 and Generation 2 oral platforms, USSF will have the manufacturing space and human resources to deploy vaccines throughout PA and the world.”

The Lehigh Valley Economic Development Corporation had assisted USSF with its previous expansion into its Allentown space last year. LVEDC assisted the company in exploring financing options, helped connect them with lenders, provided real estate sites for consideration, and helped prepare an environmental assessment request.

“We are pleased to welcome USSF to the growing life sciences sector in the Lehigh Valley,” said LVEDC President & CEO Don Cunningham. “USSF is on the front lines of the fight against COVID-19 and we’re glad to be home to its expanding operations. We appreciate the work of Governor Wolf and the Commonwealth to support the growth of this important company.”

USSF’s oral platform was originally designed and has been successfully tested to show that it produces the antibodies required to generate immunity to Diphtheria, Tetanus (lockjaw) and Pertussis (whooping cough). After the COVID-19 genomic structure was identified, this oral platform was modified to generate the appropriate proteins to produce the proper immune response in mammals.

Flanigan said the vaccine is “expected to have a dramatic positive impact on world health.”

“The jobs created focus on biotechnology and advanced manufacturing capabilities, which are resilient to economic downturn,” he said. “Further, the strategic location of this facility also allows USSF to support other vaccine formulation companies as the industry focuses on bringing this pandemic under control.”

There is currently a global shortage of pharmaceutical manufacturing capacity, further exacerbated by the COVID-19 pandemic, and very limited capacity for clinical investigators to obtain appropriately documented clinical grade materials at reasonable prices.

USSF addressed both of these market challenges by teaming up with VaxForm to adopt an emergent oral vaccine platform technology to act as a vaccine for COVID-19. Both companies are clients of Ben Franklin Technology Partners of Northeastern Pennsylvania.

The expansion project was coordinated by the Governor’s Action Team. USSF received a funding proposal from the Department of Community and Economic Development for a $291,000 Pennsylvania First grant and was encouraged to apply for a $2.4 million Pennsylvania Industrial Development Authority (PIDA) loan.