Chemists jump on pharma niche

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.

Enter US Specialty Formulations, operating under strict manufacturing regulations and practices mandated by the U.S. Food and Drug Administration.

“There is a shortage of sterile product manufacturers like us in the U.S.,” Morefield said.

Compounding, which used to be handled by a pharmacist, occurs when a physician needs a certain drug to be custom created to become a different strength, dosage, flavor or have certain ingredients excluded because of a patient’s allergies or sensitivities. Under the new law, physicians are required to contract outsourced manufacturers such as USSF.