Patient with Second Historic Pig Heart Transplant Treated with Novel Investigational Antibody Therapy Produced at Berkshire Sterile Manufacturing
Globe Newswire A historic transplant of a genetically modified pig heart has been successfully performed on a 20-year Navy veteran and married father of two suffering from end-stage cardiovascular disease.…
The ABCs of Formulation Development
https://youtu.be/lMEC3XTGsrw?feature=shared About this webinar: For many pharmaceutical and biotech companies entering preclinical and clinical studies, their formulation is still in development. While most have prepared the formulation in their own…
Berkshire Sterile Manufacturing to Host Webinar on Formulation Development for First-in-Human Studies
Globe Newswire Berkshire Sterile Manufacturing (BSM) is pleased to announce their ninth webinar in their webinar series, Sterile Filling 101, which will be held on Wednesday, September 13 at 1PM EST.…
Automated Vial Filling
https://youtu.be/jNJz6kWKt4U?si=wExnJgsxE5mcicxI About this video: Our new fully automated and isolator-based filling line can process bulk or RTU vials up to 60,000 vials per run. The line also features lyophilization capacity,…
What’s Involved in Designing Effective Lyophilization Cycles?
Developing a robust and efficient lyophilization cycle is critical to enhancing drug product stability for sensitive drug products. Lyophilization, also referred to as freeze-drying, is a complex process that removes…
Navigating the Fill Finish Process: A Step-by-Step Guide
Go to downloads page About this guide: Fill finish is a multifaceted and intricately involved production process that requires collaboration from many teams. Within this comprehensive guide, we take you…
What is an engineering run, and do you need one?
In the fast-paced and high-stakes world of pharmaceutical manufacturing, every step of the process must be meticulously planned and executed to ensure product safety and efficacy. One aspect that often…
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…
