US Specialty Formulations to Modernize Biopharma Operations with $15 Million Investment

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Editor's note: this story was originally published on BioPharmInternational.com.

US Specialty Formulations (USSF), a provider of pharmaceutical solutions for healthcare, diagnostics, and new drug developers, has begun a $15 million initiative to expand biopharma operations at its Allentown, Pa., facility, according to a July 31, 2024 press release.

USSF has already secured $4.7 million of its $15 million goal. Under the expansion, the company plans to bring in new facility cleanroom suites and state-of-the-art automated packaging and product inspection equipment. The expansion is expected to increase the company’s cleanroom production capacity by more than 2.5 times. The expansion is expected to be completed at the end of 2025. Once done, the company will have the capability to take on substantially larger projects to support growth for new and current clients.

“This expansion is a transformative step for USSF,” said Kyle Flanigan, CEO of USSF, in the press release. “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.”

In addition to raising USSF’s cleanroom capacity, the expansion is also expected to significantly boost the local economy by creating jobs and increasing revenue for the Greater Philadelphia region. When completed, USSF will seek to employ more than 100 staff to support the facility.

The company stated in its press release that cleanrooms are required to meet most pharmaceutical manufacturing standards. “They provide a highly controlled environment essential for product quality, safety, and compliance with CGMP [current good manufacturing practice] standards. These rooms provide a sterile environment for the production of injectables, including small molecules, botanicals, and vaccines.”

USSF offers a range of services, including drug R&D, contract manufacturing, private label formulations and packaging, and small-molecule pharmaceuticals. The company has developed the oral vaccine platform, QYNDR, and a self-administered drinkable vaccine, the first, according to the company. This drinkable vaccine completed a Phase I clinical trial in 2023 (1).

QYNDR is a next-generation protein-based oral vaccine (mucosal vaccine) developed to addresses the challenges seen with the current COVID-19 vaccines. According to a company press release, the results of the Phase I clinical trial showed that the vaccine demonstrated longevity and cross-variant protection from multiple COVID-19 strains. In addition, the study may possibly have identified a correlation of protection against the virus and other strains, which is to be further investigated in a Phase II clinical trial (1).

“The [P]hase I clinical data showed strong evidence that this oral platform and vaccine is a revolutionary industry disruptor and will become the preferred method of vaccination in the future,” Flanigan said in a press release issued at the time that the Phase I trial was completed. “As we proceed into Phase II and III, we are confident this next-generation vaccine will be more effective than other mucosal vaccines in current development and testing.”

Reference

1. US Specialty Formulations. US Specialty Formulations Completes Phase I of Clinical Trials for the Qyndr Vaccine. Press Release, Sept. 7, 2023.

Source: US Specialty Formulations