Sharp Acquires Berkshire Sterile Manufacturing

Sharp recently announced the acquisition of Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO) for clinical and commercial sterile injectable products. The acquisition enables Sharp to now offer a fully integrated small-to-medium scale sterile injectable service offering for the biopharmaceutical industry.

Sharp’s existing clinical supply, packaging, and distribution solutions will complement BSM’s sterile manufacturing expertise. Together, Sharp and BSM will offer global, integrated CDMO services to Biopharma customers from sterile drug product manufacturing to clinical trial services, commercial packaging, and distribution.

BSM was founded in 2014 in Lee, MA, with the mission to manufacture small-scale clinical and commercial drug products with the highest level of sterility assurance and quality achievable. BSM operates an extensive fill finish service with specialized isolator-based sterile filling of vials, syringes, and cartridges with lyophilization capabilities.  The 228 employees at BSM will bring their skills and experience into the Sharp family and continue to work from the facility in Lee, Massachusetts.

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

Dr. Shawn Kinney, BSM’s co-founder and CEO, will join Sharp’s Senior Leadership Team to drive further growth and development in sterile manufacturing services for Sharp’s customers. He will continue to lead BSM’s daily operations.  “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.”

BSM’s CTO and co-founder, Dr. Andrea Wagner, has decided to depart from the company to explore new opportunities, including creating a fund to support women in science, technology, engineering, and mathematics (STEM).

Sharp is a global leader in commercial packaging and clinical trial supply services for the pharmaceutical industry. Operating from eight state-of-the-art facilities across the US and Europe, our 2000+ strong team support pharmaceutical and biotechnology clients from phase I trials all the way through to commercial launch and lifecycle management. For more information, visit https://www.sharpservices.com/.

Berkshire Sterile is a state-of-the-art fill finish contract manufacturer that is specialized in sterile filling of vials, syringes, and cartridges for biotech and pharmaceutical industries. BSM also offers terminal steam sterilization, specialty filling, and lyophilization of vials all within isolators. Analytical support, stability studies, lyophilization development, formulation development, and method development are also offered.