Sharp Sterile Manufacturing Plans $28M Expansion
LEE, Mass. — Sharp Sterile Manufacturing is embarking on a $28 million expansion that will more than double its vial-filling capacity.
President James Hamilton said investment in the Lee facility highlights the company's commitment to meeting patients' needs while supporting highly skilled job opportunities in the region. The project will also allow Sharp Sterile to meet the demand for domestic sterile filling.
The company fills pre-sterilized containers (vials, syringes, cartridges) with drug products.
"The expansion will more than double the facility's filling capacity through the installation of a new fully automated IMA Life isolated filling line for Ready-To-Use vials. The system integrates advanced robotics, non-destructive weight checks, and a state-of-the-art lyophilizer to efficiently produce batches up to 100,000 units. These upgrades will boost Sharp Sterile's throughput, helping pharmaceutical partners bring critical therapies to patients faster," a Wednesday press release reads.
"In addition, the facility will be further upgraded to comply with the most rigorous regulatory standards for sterile drug manufacturing, ensuring the highest levels of quality and safety."
Operating since 2014, the Lee facility offers a range of pharmaceutical aseptic fill-finish solutions, including vial filling, cartridge filling, syringe filling, lyophilization, formulation development, and analytical services.
Hamilton explained that many longtime clients have received U.S. Food and Drug Administration approval to commercialize their products, and a recent trend in the pharmaceutical industry is to seek U.S.-based manufacturing alternatives for products sold to U.S. patients. These are the circumstances that showed a need for expansion.
"Sharp Sterile Manufacturing is positioned well to support this transition," he wrote in an email to iBerkshires.
The scope of work includes upgrading clean rooms and support areas to meet the most recent and rigorous requirements from the FDA and European Union, adding additional clean-room space within the existing facility to accommodate a new production line, and installing a new sterile vial filler that will more than double the existing capacity.
The new capacity is expected to be online in mid-2027. Improvements are funded internally and made possible by Sharp Services' acquisition of this business in 2023. This project is part of a broader capital expenditure program across the network of facilities in the U.S. and in Europe.
Sharp Sterile Manufacturing employs more than 200 people locally, and this expansion will create new jobs in 2026 and beyond. The company has not yet set a specific target, as "It is very dependent on the nature and timing of new development programs," Hamilton wrote.
There are 20 openings for full-time positions currently, including manufacturing technicians, scientists, and engineers.
The company has served more than 200 clients, ranging from startup biotech companies to some of the largest pharma companies in the industry.
"We currently have dozens of active clients across all phases of the drug development and commercialization lifecycle," Hamilton wrote.
"We do not sell directly to patients, but our clients produce some of the products you see and hear about every day."
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