Sharp Sterile Manufacturing expands Massachusetts site with $28M investment

Sharp Sterile Manufacturing is investing $28 million to expand its sterile manufacturing facility in Lee, Massachusetts, a move aimed at significantly increasing aseptic fill-finish capacity and supporting growing demand for U.S.-based sterile drug production.

The Lee site, which has been operating since 2014, provides aseptic fill-finish services including vial, cartridge, and syringe filling, lyophilization, formulation development, and analytical testing, according to the company. Sharp Sterile said the facility currently employs more than 200 people in the Berkshires region.

As part of the expansion, Sharp Sterile will install a fully automated isolated filling line designed for ready-to-use vials. The company said the new line will more than double filling capacity and integrate advanced robotics, non-destructive weight checks, and a lyophilizer capable of supporting batch sizes of up to 100,000 units. The upgrades are intended to increase throughput and help pharmaceutical partners accelerate delivery of therapies to patients.

In addition to the new filling line, Sharp Sterile said the facility will undergo further upgrades to align with the most stringent regulatory expectations for sterile drug manufacturing, supporting quality, safety, and compliance.

“This most recent investment in our Lee facility highlights our commitment to meeting patient needs while also continuing to support highly skilled job opportunities in the region,” Sharp Sterile President James Hamilton said in a statement. He added that the adoption of new technologies is intended to keep pace with rising demand for domestic sterile filling capacity and high manufacturing standards.

The Massachusetts expansion is part of a broader $100 million capital expenditure program across Sharp Services’ network of facilities in the U.S. and Europe that the company announced in October.