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

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.

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, lyophilisation, formulation development and analytical services.

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.

Speaking in this regard, James Hamilton, President, 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 US-based sterile filling and continue to meet the highest standards for the manufacture of sterile medicinal products.”

This investment is part of a broader capital expenditure programme across Sharp Services’s network of facilities in the US and Europe which was announced in October.