Optimizing Oligonucleotide Drug Products: Strategies for Formulation, Lyophilization, and Fill Finish Processes
Imagine if you could create a targeted, highly effective, and life-saving treatment to a disease once thought untreatable and incurable with few to no side effects. That is what the…
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…
Unique Challenges of Specialty Container Sterile Filling
https://youtu.be/Kew-t5bjPsA About this webinar: Some drug products require special containers. Depending on the container type and drug product requirements, finding a CMO to accommodate these unique needs can be a…
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…
Where Drug Product is Lost in Fill Finish and How to Limit It
Sterile filling is an important step in injectable drug product manufacturing for products that cannot withstand terminal sterilization. Unfortunately, drug product loss is inherent to fill finish. This is concerning…
Aseptic filling of unstable drug products
https://youtu.be/bQx_KsPPxuQ About this webinar: Sometimes the best therapies are hard to manufacture. When a drug product is unstable (e.g. light sensitive, shear-sensitive, temperature-sensitive), formulation and sterile filling become increasingly more…