Berkshire Sterile Manufacturing (BSM) is expanding its manufacturing facility in Lee, Massachusetts, with an estimated $20m investment.
The company began preparations for the expansion in April 2020. BSM raised $16.5m in funding from Berkshire Bank and Lee Bank in June 2020, receiving $1.5m in tax increment financing for the project from the town of Lee in October 2020.
The company will add 75 employees to its existing workforce of around 160 people over the next two years. The expanded facility is expected to be fully operational by March 2022.
Details of the Berkshire Sterile Manufacturing facility expansion
The expansion will increase the facility’s existing manufacturing capabilities by adding a 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 sterilise 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 pharmaceutical-grade water system, testing capabilities in microbiology, and analytical laboratories.
BSM doubled the size of its cleanrooms by expanding them at the 116,000ft² Lee Corporate Centre, a former toy warehouse that the company acquired in 2014.
The project also includes the development of inspection and office areas, as well as the expansion of existing warehouse and laboratory spaces.
Timeline of BSM’s facility expansion
In May 2021, BSM installed a state-of-the-art filler at its semi-automated isolator-based filling line at the facility. Developed by Colanar, the filler has a double-headed filling and stoppering station that can fill multiple container types and sizes, including vials, cartridges and syringes. It also features advanced nitrogen purging capabilities for vials and syringes, as well as on-line weight checks.
With the filler installation, BSM increased the facility’s capacity from 20,000-unit to 40,000-unit fills while improving filling accuracy, repeatability and quality.
The filler is a top-of-the-line machine with highly accurate peristaltic and rotary piston pump hook-up options for high viscosity fills, which can process up to 33 2R vials a minute. It can fill vials of between 1ml and 100ml, syringes of between 0.5ml and 20ml and cartridges of between 1ml and 20ml.
Also in May 2021, BSM bought new and improved equipment for container closure integrity testing (CCIT), product identification testing and neat testing.
The facility is being equipped with a SoloVPE analyser for the neat testing of concentrated proteins, a microplate reader for faster processing of cleanroom plates, a TruScan RM analyser for analysing the ID of products through their containers, and a LIMS system for the management of lot testing, stability and environmental monitoring.
This equipment is intended to improve the facility’s testing and analytical capabilities to support the manufacture of the clients’ drug products.
“BSM doubled its cleanrooms’ size by expanding them at the 116,000ft² Lee Corporate Centre, a former toy warehouse acquired by the company in 2014.”
In addition, BSM will expand its filling capabilities by introducing a first-of-its-kind isolator based robotic flexible filling line 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. It 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.
The facility will also be equipped with a WFI system and filler in Fedegari (SAT, IQ / OQ) isolator. The Depyro tunnel, Lyo and isolator line are due to be fully installed and validated by March 2022.
Capabilities of BSM’s existing manufacturing facility
The existing manufacturing facility includes 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 temperatures and humidity points to maintain drug products’ integrity.
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. The company fills injectable drug products for various biotechnological and pharmaceutical companies to use in clinical studies or in small quantities for commercial treatments.
BSM’s key services include sterile filling, stability programmes, analytical services and packaging distribution.