Berkshire (US) – Berkshire Sterile Manufacturing (BSM), a bio-pharmaceutical startup with 16 employees and plans to hire approximately 20 more in the coming year, has just finished the construction of state-of-the-art clean rooms, quality control and microbiology laboratories, workrooms for product formulation, final inspection, and packaging. The new Berkshire Corporate Center is equipped with the newest and most advanced technologies in the market – including Fedegari process equipment – to manufacture sterile drugs.
“We can perceive there’s a real need in the area for sterile manufacturing, not just locally but nationally,” said Andrea Wagner, BSM’s senior vice president for business development.
The biopharmaceutical firm focus on contract manufacturing sterile drugs in the pre-clinical and clinical phases for pharmaceutical, biotech, and medical device companies at its new facility. Berkshire Sterile’s services include the filling of syringes, vials, cartridges, and dual chamber devices and also provide formulation development, terminal sterilization, freeze-drying, analytical chemistry and microbiological testing, quality assurance, and stability studies.
BSM’s goal is to address the risks that are associated with drugs manufactured by small sterile drug manufacturing companies that lack adequate modern facilities and rigorous quality systems. The company plans to alleviate these concerns by using state-of-the art manufacturing equipment, isolators, flexible sterile filling equipment, and modern cleanroom and terminal steam sterilization capabilities.
“Many Aseptic Contract Manufacturing Organizations face the challenges of small batch sizes, varying primary container types and sizes, and customer expectations of the latest technologies in sterile manufacturing. It is cost prohibitive to have multiple production lines, each of which is dedicated to one primary container type (vial, syringe, cartridge, or custom). Isolators represent the current trend in sterile filling technologies, but can add significant capital expense to process manufacturing. Isolator based “flex” lines capable of multiple containers have been used by some industries, but most are unable to accommodate bulk glass vials and some require previous treatment with vapor hydrogen peroxide for all primary container packaging”, explains the CEO of BSM, Shawn Kinney.
Berkshire Sterile Manufacturing implemented a cost effective strategy using a flexible isolator based sterile manufacturing system to face this challenges. Fedegari is proudly involved in this endeavor with experts in various aspects of fill, finish and contamination control technologies. The result of this collaboration is an isolator based filling system that is able to fill the following primary containers: bulk glass vials, pre-sterilized nested vials (glass and plastic) and syringes (glass and plastic), pre-sterilized nested cartridges (glass and plastic), and custom containers (glass and plastic). The system works with both liquid and lyophilized products and the primary containers do not have to be exposed to hydrogen peroxide before entering the isolator.
“More than supplying state-of-the-art equipment to this new facility, we are investing in this partnership to face the challenges of the post-blockbuster pharma industries. We are pleased that BSM has recognized Fedegari as a partner who shares their vision for an advanced, cost-effective and flexible pharma manufacturing. We have worked together with BSM to design and develop the highest performance customized solutions for the American market. The BSM Open House represents a very promising beginning to a long and fruitful cooperation. Our partnership is making available the excellence in sterile manufacturing to improve drug industry productivity in many aspects”, said Giuseppe Fedegari, president of Fedegari Group.
BSM was recently awarded Gold for the Western Region in the12th Annual Team Massachusetts Economic Impact Awards for the expansion of its operations in Lee. The Team Massachusetts Economic Impact Awards have been presented since 2003 to honor companies that have made a significant impact on the Massachusetts economy.
Bill Bogle (Genesis Packaging Technologies), Shawn Kinney (BSM) and Giuseppe Fedegari (Fedegari Group) at BSM Open House.