Berkshire Sterile Manufacturing (BSM) is expanding its manufacturing facility in Lee, Massachusetts (MA), US.
The company began preparations for the $20m expansion in April 2020. BSM raised a funding of $16.5m from Berkshire Bank and Lee Bank in June 2020, receiving a package of $1.5m tax increment finance for the project from the town of Lee in October 2020.
The company will add 75 new employees to its existing workforce of approximately 160 people in the next two years. The expanded facility should be fully operational by March 2022.
Details of Berkshire Sterile Manufacturing facility expansion
BSM will increase its manufacturing capabilities with the installation of a new sophisticated, state-of-the-art sterile, completely robotic manufacturing line to produce sterile drug products in vials, syringes, and cartridges.
The manufacturing line will have autoclaves to sterilize equipment and a state-of-the-art system for producing water for injection (WFI) as well as a 1,500-gallon tank for storing the produced liquid.
The facility will incorporate a new pharmaceutical-grade water system, testing capabilities in microbiology, and expand its analytical laboratory.
BSM doubled the size of its cleanrooms by expanding it at the 116,000 ft2 Berkshire Corporate Center, previously a toy warehouse, acquired by the company in 2014. Installation and validation of a new glove integrity system will be completed by the end of 2020.
Equipment to be installed in the facility is being developed by the companies in the US and Europe, which will arrive at the facility in 2021.
The project also includes the development of new inspection and office areas, as well as the expansion of its warehouse and laboratory spaces.
BSM’s 2021 expansion plan
In 2021, BSM will expand its filling capabilities by introducing a first-of-its-kind isolator based robotic flexible filling line. The new line will be capable of filling up to 70,000 units of the drug component.
A filling line will have pulsed light capabilities to decontaminate ready-to-use (RTU) outer packaging.
The filling line will enable the filling of larger lots of vials (RTU and bulk), cartridges, syringes, and custom containers with improved quality and greater sterility assurance for aseptic products.
WFI system and filler in Fedegari (SAT, IQ / OQ) isolator will be installed and validated in January 2021.
Installation and validation of the new Depyro tunnel, Lyo, and new isolator line will be completed by March 2022.
Capabilities of the existing manufacturing facility
The existing manufacturing facility comprises state-of-the-art flexible filling equipment within isolators, a range of validated analytical tools to facilitate the filling of the finished products and walk-ins at different temperature and humidity points to maintain the integrity of the drug product.
It incorporates semi-automatic and manual filling lines with 100% isolator technology.
The semi-automatic filling line is fitted with a state-of-the-art flexible filler capable of filling 40,000 units of vials, cartridges or syringes.
A flexible manual fill line is configured for smaller batch fillings. The line can fill bulk or RTU vials, cartridges, syringes and custom containers.
Marketing commentary on Berkshire Sterile Manufacturing
Established in 2014, BSM is a biotechnology company based in the US. It fills injectable drug products for various biotechnological and pharmaceutical companies to use in clinical studies or in small quantity for commercial treatments.
Key services of BSM include sterile filling, stability programs, analytical services, and packaging distribution.
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