Berkshire Sterile Enhances Data Integrity with New Data Management System
Globe Newswire Data generated in the drug product process remains subject to rigorous scrutiny by the Food and Drug Administration (FDA). In particular, data originating from laboratory or manufacturing instruments…
Berkshire Sterile Manufacturing Announces Plans to Expand Lyophilization Capacity
Globe Newswire Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish CDMO, expects to double their lyophilization capacity for their fully automated, isolator-based filling line to meet new demand. A second…
Berkshire Sterile Installs Semi-Automated Visual Inspection System to Handle New Demand
Globe Newswire Delayed visual inspection due to lack of personnel is prevalent among fill finish CMOs, often leading to setbacks. Berkshire Sterile Manufacturing (BSM), a sterile filling CDMO located in…
Berkshire Sterile Secures Over $230,000 in Training Grants
Globe Newswire Berkshire Sterile Manufacturing (BSM), a fill finish CDMO based in Lee, MA, was recently awarded over $230,000 in training funds from the Massachusetts WorkForce Training Fund Program (WTFP).…
FDA Approves Groundbreaking New Product Utilizing Berkshire Sterile Excipient Gel to Treat ‘Butterfly Children’
Globe Newswire On May 19, 2023, Krystal Biotech, a client of Berkshire Sterile Manufacturing (BSM), received FDA approval for VYJUVEK™, the first-ever topical gene therapy approved to treat dystrophic epidermolysis…
Drug Product Filled with Berkshire Sterile’s Low Loss Fill Process Receives FDA Green Light
Globe Newswire RNAimmune, a biotech company focused on developing groundbreaking mRNA therapies, recently received FDA approval to begin Phase 1 clinical studies for an investigational new drug (IND). The drug…
Berkshire Sterile to discuss unique challenges with specialty container filling
Globe Newswire Berkshire Sterile Manufacturing (BSM), a Massachusetts contract development and sterile manufacturing company, will describe unique challenges and solutions to sterile filling specialty containers in a webinar on May…
Berkshire Sterile adds non-destructive weight checks to their low-loss fill line
Globe Newswire Berkshire Sterile Manufacturing (BSM), a fill finish CDMO located in Lee, MA, recently purchased a high precision load cell to perform non-destructive weight checks as part of their…
Berkshire Sterile debuts its innovative “low loss” GMP fill process
Globe Newswire Berkshire Sterile Manufacturing (BSM), a fill finish CDMO located in Lee, MA, recently completed their first GMP fill using their new low loss fill process. The process is…
