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 Quality Mission

Our mission is to provide you with a product that has the highest level of sterility assurance and quality achievable. We use the most modern technology, robust quality systems, and a dedicated staff to meet our clients’ changing requirements and critical deadlines.

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 several    walk-ins at various temperature and humidity points to preserve your drug product.