Sharp Sterile Manufacturing Announces $28M Expansion of Massachusetts Fill-Finish Site

COMPANY PROFILE
  • Sharp Sterile Manufacturing has announced a $28 million expansion of its sterile manufacturing facility in Lee, Massachusetts.
  • The project will more than double filling capacity through the installation of a new automated isolated filling line for Ready-To-Use vials.

Sharp Sterile Manufacturing has announced a $28 million expansion of its site in Lee, Massachusetts, aimed at increasing sterile fill-finish capacity and supporting skilled pharmaceutical manufacturing roles in the local life sciences community. The facility has been operational since 2014 and employs more than 200 people across the Berkshires.

The Lee site provides aseptic fill-finish and related services, including vial, cartridge and syringe filling, lyophilisation, formulation development and analytical services. The expansion forms part of the company’s contract manufacturing activities supporting pharmaceutical partners.

The project will more than double the site’s filling capacity through the installation of a fully automated IMA Life isolated filling line for Ready-To-Use vials. The system incorporates robotics, non-destructive weight checks and an integrated lyophiliser, enabling batch sizes of up to 100,000 units. According to the company, the upgrades will increase throughput and support faster delivery of therapies to patients.

In addition to capacity expansion, the facility will be upgraded to meet the most stringent regulatory standards for sterile drug manufacturing, with a focus on quality and safety.

“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.”

James Hamilton, President of Sharp Sterile

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