Berkshire Sterile Manufacturing is a fill finish contract development and manufacturing organisation with a focus on clinical and commercial sterile injectable products

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The clinical packaging site of Sharp in Bethlehem, Pennsylvania. (Credit: GlobeNewswire/Berkshire Sterile Manufacturing)

Sharp, a clinical trial supply services and pharmaceutical packaging provider, has acquired Massachusetts, US-based Berkshire Sterile Manufacturing (BSM) for an undisclosed sum.

Berkshire Sterile Manufacturing is a fill finish contract development and manufacturing organisation (CDMO) with a focus on clinical and commercial sterile injectable products.

The deal is expected to enable Sharp to provide a range of fully integrated small-to-medium scale sterile injectable services to the biopharmaceutical sector. It also expands the company’s network of capabilities in the US.

The acquisition follows the 2020 deal under which Sharp purchased a minority 25% ownership in Berkshire Sterile Manufacturing. Their partnership started in 2018 when the pharmaceutical packaging firm signed a preferred partner agreement with the latter.

According to the CDMO, the current clinical supply, packaging, and distribution solutions of Sharp will complement Berkshire Sterile Manufacturing’s sterile manufacturing expertise.

Together, the companies will provide integrated CDMO services to different biopharmaceutical customers globally. Sharp and Berkshire Sterile Manufacturing will offer services for sterile drug product manufacturing, clinical trials, commercial packaging, and distribution.

Sharp president and CEO Kevin Orfan said: “With sterile injectables a huge part of addressing this unmet medical need, the acquisition of BSM allows Sharp to provide a fully integrated solution for our biopharma clients that is a natural extension of our existing injectables and clinical packaging expertise.

“This acquisition, which builds on the existing partnership between our two companies, will greatly benefit our clients, creating an efficient manufacturing and distribution service for biotech companies developing sterile injectable products across the world.”

Established in 2014, Berkshire Sterile Manufacturing started with small-scale clinical and commercial drug product manufacturing with sterility assurance and quality.

The company now offers fill-finish services that include lyophilisation capabilities and dedicated isolator-based sterile filling of vials, syringes, and cartridges.

Berkshire Sterile Manufacturing’s 228 employees will join the Sharp family and continue to work from its facility in Lee, Massachusetts.

Berkshire Sterile Manufacturing co-founder and CEO Shawn Kinney said: “This is an exciting development for everyone at BSM and for our clients, who will benefit from a seamless downstream packaging, labelling, storage, and distribution service through Sharp’s network of facilities and expertise.”