August 5th, 2020

Sharp, a global leader in contract packaging and clinical supply services, has purchased a minority ownership in Berkshire Sterile Manufacturing (BSM).

Sharp has taken a minority 25% ownership in BSM, extending the existing preferred partner agreement that has been in place between the two businesses since 2018.

BSM offers specialized isolator-based sterile filling of vials, syringes, cartridges and containers, as well as lyophilization and terminal sterilization to small, medium and virtual pharma and biotech companies.

The agreement will allow Sharp’s Clinical division, via BSM, to offer sterile fill/finish and extend these services to Sharp Packaging’s existing rare and orphan therapy biotech customers where market demand is growing significantly.

Frank Lis, President of Sharp Clinical Services said:

“Starting in 2018, our partnership with BSM has been incredibly successful for both parties, bringing a significant number of new business leads to Sharp Clinical and enabling BSM to realize additional sales. Strengthening our relationship with a minority stake will be a great benefit to our respective clients as BSM’s capabilities are a natural extension of the existing services that Sharp offers.”

As part of the agreement Frank Lis and Kevin Orfan, President of Sharp will join the BSM board.

Shawn Kinney, CEO of Berkshire Sterile Manufacturing, added: “Having Frank and Kevin join the BSM board as part of this deal will be greatly beneficial as the collaboration between our companies grows in the years to come.”

“Their experience and expertise combined with Sharp’s well-established business development capability will help us access larger clinical and commercial biotech clients.”

The agreement will also allow further collaboration in Quality, Project Management, IT, Logistics, Storage and Distribution and will enhance our respective integrated service offerings, reducing timelines and ultimately optimizing the client experience.

The deal follows BSM’s announcement of a $20 million investment into expanding its filling capacity and capabilities. This expansion will double the company’s cleanroom and warehouse space, and bring a first-of-its-kind isolator-based robotic flexible sterile filling line. With this new line, BSM will be able to fill larger quantities of vials (RTU and bulk), cartridges, syringes and custom containers.

About Berkshire Sterile Manufacturing

Berkshire Sterile Manufacturing Inc., is a leader in high quality clinical and small volume commercial manufacture of sterile injectable drug/biologic products and medical devices. BSM utilizes state of art isolator technologies to provide the greatest sterility assurance possible.  BSM’s Lee, Massachusetts facility is FDA inspected and offers a variety of services including: sterile fill-finish, analytical and microbiological testing, stability services and regulatory support.

For more information on BSM and its service offerings, visit