Just south of Lee on Route 102, not far from the banks of the Housatonic River, sits the vast white industrial building that houses Sharp Sterile Manufacturing.

The facility came online in 2014 under the ownership of Berkshire Sterile Manufacturing. It was acquired by global pharmaceutical packaging and clinical trial supply company Sharp and renamed in October 2023.

“Our clients range from very small startup biopharmaceutical companies all the way up to some of the largest pharmaceutical companies in the business. Our clients range from throughout North America, US, Canada, but also Asia and Europe,” President James Hamilton told WAMC. “What we do here specifically, what most people can relate to, we support the manufacturer of sterile drug products. So, everybody who has seen a vial or a syringe or a cartridge that goes into a self-applicating pen, we provide that service. So, we’ll get the active pharmaceutical ingredient, either frozen or in a liquid form or in a powder form, we’ll combine it with other materials, we’ll pool it and adjust pH and all those types of things, and then ultimately, we fill it into the final sterile container.”

Sterile is the name of the game. Given the sensitive nature of the drug manufacturing process, the most crucial work at the facility happens in clean rooms with the utmost delicacy and scrutiny.

“The vast majority of the products that we produce are injectables, which means they’re either injected under the skin or directly into the vein, which means that the quality standards are tremendous,” explained Hamilton. “So, everything we do are inside of isolators, and the infrastructure and investment and training required to make that happen every single time is tremendous.”

Hamilton describes Sharp Sterile Manufacturing’s efforts as being a niche within the larger pharmaceutical industry.

“We’re not doing large scale vaccine manufacturing, that sort of thing like you would have seen during COVID,” he said. “We have the ability to do very, very small batch sizes, like sometimes- I mean, we have a client who we produce product for a single patient, and we have products where we only fill maybe 100 doses at a time, and the actual liquid batch size might be what you could fit in a can of soda.”

The new $28 million expansion will allow the company to more than double its capacity through new tech and the purchase of land around the existing campus that will add another 40,000 square feet to the already 120,000-square-foot facility.

“We are making some improvements to the existing facility, we are adding additional production suites, just the footprint within our facility to take on new capacity,” said the president. “The majority of the investment will come online in 2027, and that involves the installation of a new IMA filling line.”

Hamilton says the spending reflects the growing workload the company and its roughly 225 employees is taking on.

“We now have 13 FDA approvals of our clients’ products at the site,” he said. “So now we go from only supplying batches to support clinical trials or development processes to routine production for routine commercial sales. We also have about a dozen more that are in development. So, we need this kind of investment in capital to continue growing the business.”

One town leader says Sharp’s investment in the facility — an uncommonly large one in a small community of around 5,500 — is in line with larger goals for Lee.  

“It’s all plus for the town. It means jobs, it means money in the community. So, it’s definitely welcomed,” said select board chair Sean Regnier. “Working towards improving some of our zoning, or just being more friendly towards businesses. It will hopefully help us set ourselves up in the future for more of this sort of investment.”

The expansion also means Sharp Sterile Manufacturing is hiring.

“We do have 20 open positions at the site right now- Engineers, scientists, manufacturing technicians,” Hamilton told WAMC. “So, while I don’t know exactly what the top end of growth is going to look like, immediately, we need at least 20 more people to just fuel the growth that we have in the immediate term.”

Given the complex nature of the new high-tech equipment coming to Lee, Hamilton estimates it will take around two years for the investment to turn a meaningful revenue for the company.