A New Era for the Supply of Life-Saving Medicines: Can BFS Transform the Distribution of Biologics and Vaccines?

Blow-fill-seal (BFS) technology is being explored for one-dose presentations of vaccines and other biologics, providing a continuous, automated process that can lower manufacturing costs, increasing access for patients worldwide. Other BFS benefits for biologics developers include enhanced automated processes with minimal human intervention, lower risk of foreign body contamination, and a high level of container integrity control during fill and finish. Manufacturers also appreciate the minimised risk of breakages during shipping and improved administration usability for clinicians and patients.
However, implementing BFS for biologics and vaccine projects comes with challenges:

• Ensuring chemical and physical compatibility of the container and the overall blow-fill-seal process with the drug formulation
• Demonstrating effective drug stability within the container
• Determining acceptable extractable and leachable profiles.