Could a vaccine for COVID-19 be developed right here in the Lehigh Valley? It’s possible thanks to an early-stage pharmaceutical company, which last year purchased a building on Allentown’s south side after outgrowing its existing production facility in Bethlehem.

US Specialty Formulations LLC
is a contract CGMP manufacturer and one of the first 503B Drug Quality and Security Act outsourcing facilities registered with the U.S. Food & Drug Administration. It cost-effectively produces specialty formulations of pharmaceuticals in small batches for larger pharmaceutical and healthcare organizations. USSF focuses on two lines of business: specialty products, such as topicals and sterile injectables for both humans and animals; and investigational drugs for clinical trials.

USSF is partnering with fellow Ben Franklin Technology Partners TechVentures resident company VaxForm, LLC, which is owned by USSF co-founder Dr. Garry Morefield, on the development of a COVID-19 vaccine.

“Pre-clinical trials will start soon,” said Dr. Kyle Flanigan, Co-Founder and CEO of USSF. “If the vaccine is approved, we will need to ramp up production very quickly, producing between 500,000 and 600,000 doses per month. We also have the ability to provide a manufacturing facility for the rapid turnaround for first responder pharmaceuticals.”

Founded in 2013 by Flanigan and Morefield, USSF started business in 2013 with $200,000 from investors and loans. By 2014 it had entered the Ben Franklin TechVentures business/technology incubator as a resident company, at which it located its first clean room. Ben Franklin Technology Partners also invested a total of more than $156,000 in the firm. Being part of BFTP gave the fledgling company time to test its business model of producing its product in low volumes to determine if it met Food and Drug Administration guidelines.

“We’ve been impressed with the growth USSF has had over the past few years,” said Anthony Durante, Manager of Entrepreneurial Support for the Ben Franklin Technology Partners. “With the work USSF is doing with VaxForm on a COVID-19 vaccine, we’re excited to see two Ben Franklin client companies teaming up to battle this pandemic and help prevent future outbreaks of the virus.”

In 2019, USSF was ready to expand and began touring various properties with the help of AEDC staff members Scott Unger and David Dunn. USSF owners, Flanigan and Morefield, eventually purchased a 41,000 sq. ft. building at 101 E. Lexington Street with the assistance of a $250,000 Pennsylvania Minority Business Development Authority loan. PMBDA is administered by Allentown Economic Development Corporation as part of its Urban Made initiative. The loan allowed for the purchase of the building, the sale of which closed in March 2019, followed by the start of the five-year build-out plan.

“We were extremely pleased to work with USSF to help them find and purchase the right building within Allentown city limits,” said AEDC’s Loan Program Manager, David Dunn. “Plenty of room for expansion was a key factor in the decision, and this particular property has an abundance of renovation potential.”

Phase 1 part 1 began with the installation of 800 sq. ft. and 300 sq. ft. temporary cleanroom suites, which allow USSF to perform limited aseptic production. The company also moved its warehouse and staff to the new site as it continues to work on bringing the building up to standards.

It is now gearing up for phase 1 part 2 during which the company will shift its manufacturing from Ben Franklin TechVentures to the Allentown site, along with its analytical lab for quality testing. It expects to complete this phase by the end of May.

By the end of 2020, USSF is expecting to grow its current staff of 14 to between 30 and 40 people, most of whom will be full-time employees. While some new team members might be found locally, the company is prepared to conduct a national search to identify the right scientists.

Phase 2 will feature the construction of permanent clean room suites ranging in size from 2,000 sq. ft. to 10,000 sq. ft. It will also add a second floor to the building. “Right now there are longer-than-normal lead times to order and buy the specialty equipment that we need. So we don’t know just yet how soon phase 2 can begin,” said Flanigan.

The improvements to the building over the past year haven’t gone unnoticed by neighbors either. “People familiar with the building prior to our purchase tell me how impressed they are with the significant changes that we have made, and what a big difference they have seen in the building from before we purchased it,” added Flanigan. “That’s great to hear because we really expect great things from this new site!”