Sharp Sterile Manufacturing has announced a $28 million expansion of its site in Lee, Massachusetts. The enhanced state-of-the-art facility will strengthen opportunities for highly skilled engineering and pharmaceutical manufacturing roles within the local life sciences community and represents a major milestone in Sharp Sterile’s development.

The Lee facility, which has been in operation since 2014, offers a range of pharmaceutical aseptic fill-finish solutions, including vial filling, cartridge filling, syringe filling, lyophilization, formulation development and analytical services. Sharp Sterile Manufacturing currently employs more than 200 people across the Berkshires.

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.

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.

James Hamilton, President of Sharp Sterile, said: “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. By advancing with new, innovative technologies, we are ensuring our capabilities keep pace with the expanding demand for U.S.-based sterile filling and continue to meet the highest standards for the manufacture of sterile medicinal products.”