Berkshire Sterile Manufacturing (BSM) specializes in providing high-quality sterile drug products tailored for clinical and small-scale commercial needs. The company employs advanced isolator-based filling technology, which ensures maximum sterility assurance by physically separating operators from the filling process. BSM offers a range of filling options, including vials, syringes, cartridges, and custom containers, along with lyophilization services for sensitive drug products. Their onsite laboratory supports analytical services, development, and stability studies, ensuring that each product meets stringent quality standards.

The development process at BSM is guided by the Quality by Design (QbD) framework, which emphasizes a systematic approach to product and process understanding. This involves defining the Quality Target Product Profile (QTPP) and identifying Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) to ensure product quality. BSM utilizes Design of Experiments (DoE) to evaluate potential strategies for achieving desired outcomes, allowing for continuous monitoring and improvement of processes post-validation. This comprehensive approach ensures that BSM delivers products that meet the highest standards of sterility and efficacy.

United States

It is Berkshire Sterile Manufacturing’s (BSM) goal to provide the safest sterile drug products possible for clinical use and small scale requirements. BSM will provide small scale sterile manufacturing services with 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 will also provide ancillary support to their clients’ drug productions such as analytical method development and validation, stability studies and formulation scale up.

Berkshire Sterile Manufacturing

Company Details