By R. Chadwick Paul, Jr., President and CEO

For more than 18 years, I have had the privilege of leading the Ben Franklin Technology Partners of Northeastern Pennsylvania. Along the way, we have mentored and supported a variety of companies in many different technology and manufacturing sectors. Several of these companies have gone on to significantly impact their respective industries and address crucial societal problems, such as the COVID-19 pandemic.

US Specialty Formulations, LLC., founded by Kyle Flanigan, PhD, is a Current Good Manufacturing Practice (cGMP) manufacturer of sterile injectable pharmaceuticals used by healthcare providers or in new drug or vaccine clinical trials. Millions of Americans require specialized and custom-manufactured drugs. These specially prepared drugs are U.S. Food & Drug Administration (FDA)-approved medications and are marketed globally.

USSF teamed with another Ben Franklin founder, Garry Morefield, PhD, VaxForm LLC, and recently announced positive pre-clinical results in its joint development program to bring oral COVID-19 and other vaccines to market in 2021.

Two Lehigh Valley companies that have partnered to develop and manufacture a pair of COVID-19 vaccines said they may have a vaccine to market by spring of next year.

Two promising new COVID-19 vaccines show positive results in pre-clinical trials, developed through an alliance formed by Ben Franklin clients VaxForm LLC, a vaccine development company, and US Specialty Formulations LLC (USSF), a cGMP pharmaceutical manufacturing company. These new vaccines utilize novel delivery platforms for COVID-19 with one oral delivery and the other a conventional injectable. Both vaccine formulations produced antibodies in 100% of mice in pre-clinical trials.

The company alliance was formed in the Ben Franklin TechVentures business/technology incubator, at which both companies are headquartered. Coverage via Lehigh Valley Business

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.

It’s been said that everything new has been done before. And while that might be true to some degree, when your startup is one of only a handful of companies in the country doing what it does, it means your business trajectory is different from other startups.

US Specialty Formulations LLC is a contract 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.

The company can manufacture these critical materials from a recipe provided by a client or can develop a formula and teach the client how to produce it. But it specializes in manufacturing low volumes of a 50,000-unit batch size or smaller. “There aren’t lot of companies doing what we’re doing,” said Dr. Kyle Flanigan, Co-founder and CEO. “We make a little of a lot of things!”

Time to expand

Now, six years later, the company is ready for its next expansion, which will be in Allentown. But before settling on a 40,000 sq. ft. building at 101 E. Lexington Street on the city’s south side, Dr. Flanigan and his business partner Dr. Garry Morefield, considered sites in Florida and Arizona, as well as other parts of the Commonwealth.

The move will give the growing company space that’s roughly 37,000 square feet larger than its current home of 3,000 square feet. The company, US Specialty Formulations LLC, needs more space, said its co-founder and CEO, Kyle Flanigan.

Three years ago, we recognized we were getting a lot of requests from customers to handle projects that were larger than what we could handle at our current site,” Flanigan said. “The goal was to find a building regardless of the site. In a modern business environment, that physical location is irrelevant in our case because we had special needs for the building.

The company looked at a number of sites, including Arizona, Florida and New York before settling on Allentown. Flanigan said he wanted to find an existing site that was affordable, rather than building new. US Specialty Properties LLC recently paid $1 million for the 40,810 square-foot building, which is at 101 E. Lexington St. in Allentown, according to Lehigh County property records. The LLC is a separate company with similar principals, Flanigan said.

US Specialty Formulations has been operating since 2013 out of Ben Franklin TechVentures, a workspace for early stage companies on Lehigh University’s Mountaintop Campus in Bethlehem. The startup environment allowed the company to establish itself, but Flanigan said the new site will offer more space for manufacturing and testing products, in addition to space for employees. Right now, it has 13 workers but Flanigan said he is looking to hire more.

A pharmaceutical startup in the Ben Franklin Technology Partners of Northeast Pennsylvania Tech Ventures in Bethlehem is expanding. US Specialty Formulations LLC, a specialty pharmaceutical manufacturer, plans to add space and three new highly skilled positions to its staff. According to Ben Franklin, there is a great need for specialized and custom-manufactured drugs, and the existing infrastructure isn’t sufficient to support their manufacture, leaving them to be produced in pharmacies and other facilities that are inconsistent and less regulated.

As a U.S. Food and Drug Administration-registered outsourced manufacturer, US Specialty Formulations LLC bridges that gap to provide the proper environment for the production of those pharmaceuticals, the incubator said in a release. Kyle Y. Flanigan, CEO of US Specialty Formulations, said the outsourced facility needs to comply with the FDA’s 2014 Drug Supply Chain Security Act. Because of that, his company deliberately has been taking its time on its growth strategy, he said this morning.

“We started out at Ben Franklin to get our business model and regulatory model ironed out and aligned to what the FDA is requiring,” Flanigan said. “We’re further along on that path, so it’s time to expand.” Flanigan said the expansion will enable the company to take on larger contracts to make larger batches of materials. The company focuses on specialty sterile injectable drugs for humans and animals.

Bethlehem, PA – Today, Governor Tom Wolf visited TechVentures on his “Jobs That Pay” Tour. Ben Franklin TechVentures (BFTV) is an award-winning technology-based incubator and post-incubator facility that is owned and managed by Ben Franklin Technology Partners of Northeastern Pennsylvania (BFTP/NEP). BFTP/NEP is an initiative of the Pennsylvania Department of Community and Economic Development and creates and retains highly paid, sustainable jobs by linking companies with experts, universities, funding, and other resources to help them prosper through innovation.

Since beginning operations, BFTP/NEP has helped to create more than 16,000 new jobs for Pennsylvania workers. I’m thrilled to meet with the extremely talented staff and companies working at TechVentures, an award-winning accelerator doing great work in the Lehigh Valley,” said Governor Wolf on the tour today. My administration remains committed to moving Pennsylvania forward by creating a business climate that supports Pennsylvanian entrepreneurs like these.

It is important that we continue to support programs like TechVentures so that entrepreneurs feel safe to take risks on their business ideas and know that they are supported in their efforts to do so.”

Advanced materials developer Kyle Flanigan always dreamed of a job as a commander on a space station. Advanced materials developer Kyle Flanigan always dreamed of a job as a commander on a space station. The closest he came to fulfilling this aspiration was an assignment to work on a space program at Intel Corp. in Portland, Ore., to make computer chips for space shuttles. But the project folded and Flanigan’s path took a new course.

Years later, that path would cross with fellow chemist Garry Morefield and blossom into a business partnership and a yearlong development process to start US Specialty Formulations, a clean and sterile small-batch pharmaceutical manufacturing company in Bethlehem. US Specialty Formulations now is one of the few in the nation positioned to fill a newly created gap in what the men refer to as “a gray area of the pharmaceutical industry, called compounding. Our business model approaches it from an advanced materials and clean manufacturing angle, rather than a pharmacist’s angle, Flanigan said.

It’s a model that could be in the right place at the right time. Last November, President Barack Obama signed the Drug Quality and Security Act in response to pharmacies that were producing larger quantities of drugs than regulations allow, making for an unsafe and unsterile production environment.