Berkshire Sterile Manufacturing (BSM)
Berkshire Sterile Manufacturing, soon to be Sharp Sterile Manufacturing, is a leading provider of small-scale sterile drug manufacturing services with a focus on quality, innovation, and customer collaboration. Established in 2014, the company offers a range of sterile filling services including manual, semi-automated, and fully automated lines, with capabilities for vial, syringe, cartridge filling, lyophilization, and more. The company emphasizes high sterility assurance, advanced technology, and a dedicated team to support clinical and small commercial drug production. Berkshire Sterile Manufacturing is part of Sharp, a global leader in pharmaceutical packaging and clinical trial supply services.
Industries
Nr. of Employees
medium (51-250)
Berkshire Sterile Manufacturing (BSM)
480 Pleasant Street, Lee MA 01238
Services
Aseptic filling of vials, pre-filled syringes, cartridges and specialty containers using isolator-contained manual, semi-automated, and automated lines; options for nitrogen headspace and handling of viscous and oxygen-sensitive formulations.
Design and execution of stability study protocols to support shelf-life determination and regulatory submissions.
Analytical method development, method transfer, method validation, release testing, and microbiology QC support to ensure testing meets cGMP standards.
Formulation optimization, lyophilization cycle development, filtration strategy, and method development to prepare drug products for clinical manufacturing and tech transfer.
Coordination of packaging, labeling, kitting, storage and distribution services via affiliated packaging and clinical supply partners to support clinical supply and small-scale commercial launches.
Aseptic filling of vials, pre-filled syringes, cartridges and specialty containers using isolator-contained manual, semi-automated, and automated lines; options for nitrogen headspace and handling of viscous and oxygen-sensitive formulations.
Design and execution of stability study protocols to support shelf-life determination and regulatory submissions.
Analytical method development, method transfer, method validation, release testing, and microbiology QC support to ensure testing meets cGMP standards.
Formulation optimization, lyophilization cycle development, filtration strategy, and method development to prepare drug products for clinical manufacturing and tech transfer.
Coordination of packaging, labeling, kitting, storage and distribution services via affiliated packaging and clinical supply partners to support clinical supply and small-scale commercial launches.
Expertise Areas
- Aseptic fill-finish manufacturing
- Lyophilization process development and scale-up
- Formulation development for injectables
- Analytical method development and validation
Key Technologies
- Isolator-based aseptic filling
- Freeze-drying (lyophilization)
- Peristaltic pumps
- Piston pumps