ICIS

PCI Synthesis

Business:
Active pharmaceuticalingredients (APIs), fine chemicals
Annual sales: $12-14m (€7.5m-8.8m)
Headquarters: Newburyport, Massachusetts, US


Not a Quitter


What do you do if your plant is destroyed? In 2005, Ed Price, president of PCI Synthesis, found out.
"If I didn't find a plant and move quickly, we'd have been out of business," he recalls.

At the time, Price was president of PolyCarbon Industries (PCI), which had a good manufacturing process (GMP) manufacturing facility in Leominster, Massachusetts, and research and development (R&D) operations in Devens. The company, founded in 1998, was doing well, with two active APIs commercialized and another eight in the pipeline.
But an explosion in March 2005 put the Leominster facility out of commission.

"Fortunately, we had built up some inventory on our commercial products, but we didn't have a lot of time - only eight or nine months," says Price.

Price was lucky. Just up the road in Newburyport, Massachusetts, Norway's Borregaard Synthesis had a multipurpose facility for sale. The site had 18,000 gallons (68,000 liters) of reactor capacity, compared with PCI's 1,200, and the excess could easily accommodate PCI's needs. However, it was not an API facility.

"We had to acquire the new site and not only bring it up to speed for GMP, but we also had to get it inspected by the Food and Drug Administration (FDA)," Price points out.

Within 11 months, Price and his team converted the facility to GMP manufacturing, but they were still at the mercy of the FDA.

"It was do or die - if the FDA didn't come [soon enough], we were finished, and if it did come and we failed, we were finished," he says. But the agency did come, and after a five-day inspection, the company was free to go forward. All of PCI's customers stuck with the company.

"We were able to keep every one of our APIs alive with our partners," notes Price. "We've had a long-standing relationship with these people. We've always done what we said, and always delivered what we said we would."

The company, larger by $8m in revenue and several nonpharma product lines, was renamed PCI Synthesis.
Competition has been stiff, says Price, but overall business has been on a positive trend.

"The exchange rate and the price of energy and oil are making things more difficult right now, but in the long term, it's good for US manufacturers," he says.

His staff, now numbering 65, has been key to the success of PCI Synthesis, he adds.

"We have very little staff turnover," he says. "No-one's left the company voluntarily in more than six months. My key managers have worked with and for me for over a decade at PCI and [the Newburyport facility]. I've known them for a long time, and everyone is committed to success."