SFF
Blow-fill-seal (BFS) technology is on the rise due to the increasing demand for biologic drug products and vaccines. On an automated filling line, a container is formed under aseptic conditions, and the drug formulation is filled and sealed in a continuous process. Using BFS approaches lowers manufacturing costs and expands access to innovative treatments in lower-income regions. As terminal sterilisation is not viable for biologic and vaccine products due to their sensitivity, BFS technology supports and meets the necessary sterile requirements. As a result, the BFS technology market is predicted to grow at a compound annual growth rate of 9% from $2.8 billion in 2022 to $6.2 billion in 2031 [1].
In addition, BFS containers offer features that make them an attractive option for pharmaceutical developers and manufacturers, including:
- Automating the process to streamline production and minimise the risk of microbial and particulate contamination due to human intervention, maintaining optimum sterile integrity.
- Compatibility for both small-batch clinical and high-volume commercial filling.
- Design flexibility, with a range of shapes and sizes to suit the needs of the drug product.
- Removing the need for preservatives in the drug formulation to ensure quality or safety.
- Reducing the risk of breakage during transport as the containers are made of plastic, minimising waste.
However, traditional BFS approaches have relied on the use of high temperatures to form and seal the container, which is incompatible with sensitive biologic and vaccine materials. Recent innovations such as the introduction of alternative container materials and the use of water-based mould cooling mean BFS processes can be completed at temperatures low enough to safeguard biologic and vaccine stability.
As the biopharmaceutical industry continues to consider BFS for biologic and vaccine production, a thorough understanding of the drug product and continued innovation of BFS approaches are key. Partnering with contract development and manufacturing organisations (CDMOs) that specialise in BFS filling can help to successfully navigate BFS processes and meet production needs.
To discover more, read the full article by our expert, Vincenza Pironti, Head of Business development at Recipharm, focusing on the growing biologic market and technological innovations that are driving BFS capacity.
Reference:
- Blow Fill Seal (BFS) Technology Market Is Expected to Reach, accessed 6 February 2024, from Globe newswire's news release.