About Us

About Us

Berkshire Sterile Manufacturing (BSM) was founded in 2014 by three industry experts totaling more than 50 years of experience in sterile drug manufacturing.  Their goal was to develop a process capable of providing the safest sterile drug products for clinical use and small scale requirements achievable.  BSM has grown significantly since its inception, without wavering from its quality mission.

BSM provides small scale sterile manufacturing services with the highest level of sterility assurance and quality achievable through the use of the most modern technologies for sterile manufacturing, stringent quality standards and highly trained employees.  BSM also provides ancillary support to their clients’ drug productions such as analytical method development and validation, stability studies and formulation scale up.

Our Expert Leadership Team

We are armed with an experienced leadership team with a focus on quality, delivery, and compliance. Our team is equipped with the knowledge you need to develop your drug correctly and effectively.

Our Modern Facility

Our manufacturing facility is top-of-its-class, consisting of state of the art flexible filling equipment within isolators, an array of validated analytical instruments to support your fill finish product, and walk-ins at various temperature and humidity points to preserve your drug product.

2021 Expansion

We are currently undergoing a $20 million expansion to add a third filling line that will be fully automated, 100% isolator-based, and highly flexible. We will be able to fill lots up to 60,000 units. This new line will be able to process bulk and RTU vials, syringes, cartridges, lyophilized products, and more. This line will also feature new technologies to enhance the quality and sterility assurance for drug product fills.

Upcoming Webinar:

Wednesday, January 12th | 1PM EST

Wednesday, January 12th | 1PM EST

A VHP validation approach to a multi-chamber and complex filling line