US Specialty Formulations (USSF), a provider of pharmaceutical services for healthcare, diagnostics and new drug developers, has announced a $15 million expansion of its Lehigh Valley biopharma facility in Allentown, creating more than 100 jobs. 
 
The expansion will bring new facility clean room suites and state-of-the-art automated packaging and product inspection equipment. The 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. 
 
Clean rooms provide a highly controlled environment essential for product quality, safety and compliance with cGMP standards, providing 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, built their first certified clean room at Ben Franklin Technical Incubator. This expansion will be USSF’s third generation of clean rooms, incorporating the basic cGMP and quality ideals. 
 
“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 offers a range of services, including drug research and development, contract manufacturing, private label formulations and packaging and small molecule pharmaceuticals. 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.