Governor Tom Wolf announced that U.S. Specialty Formulations (USSF), LLC, a pharmaceutical manufacturing company, will expand its operations in Allentown, Lehigh County to continue its work developing a COVID-19 vaccine in partnership with VaxForm, LLC. This project will create at least 97 new, high-paying positions at the site.
“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,” said Gov. Wolf. “My administration is eager to support the growth and job creation of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe.”
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.
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).
This 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. USSF will be providing clinical materials from its Allentown plant for the human phase one clinical safety trials scheduled to begin in February 2021.
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 project was coordinated by the Governor’s Action Team, an experienced group of economic development professionals who report directly to the governor and work with businesses that are considering locating or expanding in Pennsylvania.
“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.”
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.”
USSF was founded in 2013 and produces a variety of pharmaceuticals in a state-of-the-art facility that exceeds quality standards outlined in U.S. Pharmacopeia (USP) and FDA guidelines, and adheres to the Current Good Manufacturing Practice (cGMP) and thereby lowers the total risk of using Outsourced Facility pharmaceuticals. The company utilizes a small batch disposable model to support healthcare providers and investigational new drug sponsors on a global scale. By registering some formulations under its FDA Outsourced Facility designation, USSF addresses the need caused by interruptions in the availability of specialty pharmaceuticals. USSF focuses on high-value formulations, allowing the company to provide a much larger portfolio of products to customers at both global and regional levels. USSF’s portfolio has expanded to include injectables and nasal presentations as well as tropical pharmaceuticals as a response to customer demands. The company is also the global single source of four prescription medications.