From Bench to Bedside: The Journey of Oligonucleotide Drug Development and Sterile Filling
Go to downloads page About this white paper: This white paper serves as a comprehensive guide to enhancing the formulation, lyo cycle development, and fill finish process of oligonucleotide therapeutics.…
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…
