US Specialty Formulations Announces $15M Expansion To Modernize Biopharma Operations

Expansion will bring jobs along with millions of dollars in economic impact to region

US Specialty Formulations (USSF), a leading provider of high-quality pharmaceutical solutions for healthcare, diagnostics and new drug developers, is thrilled to announce an expansion of its Lehigh Valley biopharma facility.

USSF's commitment to innovation is reflected in this multi-phase, $15M initiative. With $4.7M already secured, the expansion will bring new facility clean room suites and state-of-the-art automated packaging and product inspection equipment. This expansion will increase USSF's clean room production capacity by more than 2.5 times and, once completed at the end of 2025, will enable the company to undertake substantially larger projects supporting growth for new and current clients.

The expansion is expected to significantly boost the local economy through job creation and increased revenue for the Greater Philadelphia region. At its completion, USSF hopes to employ more than 100 people to support the Allentown facility.

Clean rooms are the heart of a pharmaceutical facility and are required to meet most pharmaceutical manufacturing standards. They provide a highly controlled environment essential for product quality, safety and compliance with cGMP standards. These rooms provide a sterile environment for the production of injectables, including small molecules, botanicals and vaccines.

Established in 2013, Co-founders Dr. Kyle Flanigan, CEO, and Dr. Garry Morefield, COO, with their combined capabilities and expertise, hand-built their first certified clean room at Ben Franklin Technical Incubator, which is extremely uncommon in the biotech industry. As the company grew, the need for larger clean rooms became apparent. This expansion will be USSF’s third generation of clean rooms, incorporating the basic cGMP and quality ideals, as well as lessons learned from its past 11 years serving a wide variety of customers and customer formulations.

"This expansion is a transformative step for USSF," said Dr. Flanigan. "By investing in cutting-edge technology and streamlining our manufacturing processes, we are raising the bar for ourselves and reaffirming our commitment to delivering innovative pharmaceutical solutions that reduce the risk profile of new drug development or contract manufacturing and ultimately improve patient lives. This expansion empowers our dedicated team to serve our partners and clients worldwide more effectively."

USSF has established itself as a leader in the life sciences industry by offering a comprehensive range of services, including drug research and development, contract manufacturing, private label formulations and packaging and small molecule pharmaceuticals. Notably, the company is known for pioneering QYNDR, the oral vaccine platform and the first self-administered drinkable vaccine, which completed a successful Phase I clinical trial in 2023.

As USSF embarks on this exciting growth chapter, the company remains committed to providing the highest-quality, customized pharmaceutical solutions that contribute to a healthier future for patients worldwide.