USA – Sharp, a provider of commercial pharmaceutical packaging and clinical trial supply services, has acquired Berkshire Sterile Manufacturing (BSM).

BSM is a fill-finish contract development and manufacturing organization (CDMO) for clinical and commercial sterile injectable products, based in Massachusetts.

The acquisition enables Sharp to provide a comprehensive and integrated service for the small-to-medium scale sterile injectable needs of the biopharmaceutical industry.

Sharp’s existing clinical supply, packaging, and distribution services will complement BSM’s expertise in sterile manufacturing.

Sharp and BSM will provide comprehensive global CDMO services to Biopharma customers, ranging from sterile drug product manufacturing to clinical trial services, commercial packaging, and distribution.

Kevin Orfan, President and CEO of Sharp, said, “The market continues to demand expertise and capacity in sterile manufacturing, partly due to the growth in therapies for rare and orphan diseases.

“With sterile injectables being a significant aspect of addressing this unmet medical requirement, the acquisition of BSM allows Sharp to offer a fully integrated solution for our biopharma clients. This acquisition serves as a seamless extension of our current expertise in injectables and clinical packaging.”

The 228 employees at BSM will contribute their skills and experience to the Sharp family and will continue working from the facility in Lee, Massachusetts.

Shawn Kinney, the co-founder, and CEO of BSM, will be joining Sharp’s senior leadership team. His role will be to drive growth and development in sterile manufacturing services for Sharp’s customers. He will continue to lead BSM’s daily operations.

Kinney added, “This is an exciting development for everyone at BSM and for our clients, who will benefit from a seamless downstream packaging, labeling, storage, and distribution service through Sharp’s network of facilities and expertise.

“With Sharp’s support, I am looking forward to the opportunity to grow the sterile manufacturing business and to broaden our reach in the service of our clients and their patients.”

Meanwhile, in August, Sharp appointed Grace Breen as the Senior Vice President of Global Quality to oversee the Quality function throughout the company.

Grace joins Sharp’s senior leadership team and will leverage her rich global Quality and Compliance experience to enhance Sharp’s leadership in providing Commercial Packaging and Clinical Services that improve patients’ lives.

In her role, Grace will be responsible for leading and further maturing the Quality culture program at Sharp, and for enabling an effective Pharmaceutical Quality System that consistently meets client and regulatory requirements.

Her career spans over 30 years in the global pharmaceutical industry, during which she has held global Quality leadership roles at Catalent, Hospira, Impax, and most recently, at SCA Pharma.