US Specialty Formulations announced it will be expanding its Allentown manufacturing location to add new clean room suites and state-of-the art automated packaging and product inspection equipment. 
"This expansion is a transformative step," said CEO Dr. Kyle Flanigan, one of the company’s co-founders. "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."
US Specialty Formulations (USSF) produces sterile injectable, topical, and specialty pharmaceuticals. It manufactures its own branded prescription products and provides clinical materials for investigational new drug applications, specialty formulations, adjuvants and fermentation and purification services requested by biotech companies.
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.
The $15 million expansion is planned to occur in multiple phases, with $4.7 million already secured. At its completion, USSF hopes to employ more than 100 people to support the Allentown facility.
The expansion will increase the company'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 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.
US Specialty Formulations was established in 2013 by Flanigan and COO Dr. Garry Morefield. They started at the Ben Franklin TechVentures incubator in Bethlehem, where they hand built their first certified clean room. In need of additional space, the company left TechVentures in 2019 and relocated to its current location in Allentown.
The announced expansion will be the company’s third generation of clean rooms.
The expansion is the latest in the Lehigh Valley’s growing life sciences sector. Nearly 7,000 people work at about 170 companies, including internationally recognized brands such as B. Braun Medical, Olympus, Sharp, and OraSure Technologies, another home-grown company that got its start at Ben Franklin.
In May, Wacker Chemical Corp. expanded its presence in the Lehigh Valley by acquiring the assets of Bio Med Sciences.
Wacker, based in Germany, plans to use the technology acquired from Bio Med Sciences as a development platform for innovations in stick-to-skin applications, such as wearable medical devices and scar care. With the new assets and its existing silicones portfolio, Wacker can provide processing recommendations with technical service to coaters and product designers. Also, customers will have access to new silicone adhesive coated products through contract manufacturing.
(Photos courtesy of US Specialty Formulations)