U.S. Specialty Formulations, a pharmaceutical manufacturing company, will expand its operations in Allentown to continue its work developing a COVID-19 vaccine in partnership with VaxForm, LLC. This project will create at least 97 new jobs in Lehigh County, Pennsylvania.

USSF will expand its 41,000-square-foot facility in Allentown and will request an FDA Emergency Use Authorization (EUA) approval to release a COVID-19 oral and injectable vaccine in mid-2021. In order to meet its schedule, the company must make renovations, acquire equipment, and hire new employees.

“Completion of the USSF expansion will add a significant capability and capacity for our offerings and specifically to the oral Vaccine Platforms. 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,” said USSF CEO Dr. Kyle Flanigan. “This 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. 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.”

USSF received a funding proposal from the Department of Community and Economic Development (DCED) for a $291,000 Pennsylvania First grant and was encouraged to apply for a $2.4 million Pennsylvania Industrial Development Authority loan. The company has committed to invest at least $5.2 million into the project and company will create 97 new, high-paying jobs and retain 14 more positions.

The company also received more than $225,000 in funding from DCED through the COVID-19 Vaccines, Treatments and Therapies (CV-VTT) program to support the rapid advancement of vaccines, treatments and therapies by qualified biotechnology entities in response to the COVID-19 pandemic. The program, announced in July, was made available to Pennsylvania-based entities that demonstrate both a financial need and a well-defined pathway to the accelerated commercialization of a new vaccine, treatment or therapy in direct response to fight against COVID-19.

“We are pleased to welcome USSF to the growing life sciences sector in the Lehigh Valley,” said Don Cunningham, president and CEO of the Lehigh Valley Economic Development Corporation (LVEDC). “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.”

According to state officials 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. USSF has been able to address both of these market challenges. USSF has also partnered with fellow Ben Franklin Technology Partners company VaxForm, LLC, to adapt an emergent oral vaccine platform technology to act as a vaccine for SARS-CoV-2 (COVID-19).