Why a CDMO more efficient tham CRO+CMO


Operating two sites in the Greater Boston area, PCI Synthesis’ pharmaceutical development contract manufacturing organization (CMO) business has grown in recent years—aiding the company in its emergence as the largest small molecule drug substance manufacturer in the New England area. PCI Synthesis is a custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products.

Based in Massachusetts, the company’s headquarters and commercial/development cGMP manufacturing facilities are located in Newburyport, while its small-scale manufacturing and R&D facility is located in Devens.

“The company was originally founded in 1998,” said Ed Price, President and CEO of PCI Synthesis. “We really began as a small scale chemical manufacturer. Our niche at the time was tens of kilos—we were not a company who had big vessels, so we did not do large projects and we did not do very sophisticated, small-volume chemistry.

“When we started, during the first three or four years of the company, our customers were primarily big pharma companies who came to us because they didn’t want to develop these starting materials and building blocks internally, but there were no commercial manufacturers for these molecules.

“In 2005, there was a fire in our facility in Leominster, and I purchased a site in Newburyport in 2006. When I purchased the site in 2006, I basically had two companies I was trying to put together.”

From 2006 to 2009, the company continued to manufacture any existing projects.

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