Leveraging Blow-Fill-Seal Technology for Biologic Delivery

Close-up of numerous medical vials in a pharmaceutical manufacturing line | Image Credit: ©MP Studio - Stock.adobe.com

The demand for blow-fill-seal (BFS) technology has significantly increased in recent years because of the rising demand for biologic-based drug products and vaccines. Valued at $2.8 billion in 2022, the BFS technology market is predicted to grow at a compound annual growth rate of 9% until 2031, to reach $6.2 billion (1).

Created through automated manufacture, BFS is being explored for unit dose containers for vaccines and other biologic products. This BFS process can positively impact the overall supply chain, lowering manufacturing costs and enabling treatment for populations in lower-income regions.

Understanding the benefits of BFS

BFS technology is a form of advanced aseptic manufacturing in which a container for a drug formulation is formed, filled, and sealed in a continuous, automated system. To create the aseptic container, manufacturers continuously melt polymer granules to extrude a sterile, formable polymer parison into a mold. Sterile air is used to blow-mold the material into a container, forcing the polymer to take the shape of the mold and create a hollow space within. This container is filled with a drug formulation before being sealed tightly, traditionally through the application of both heat and pressure to the open end of the vessel.

All containers have features that can make them more or less suitable for a particular project. BFS is no different, offering features that make it an increasingly attractive option for pharmaceutical companies developing or manufacturing sterile liquids, including injectables. For example, BFS containers:

Maintain high sterility and particulate contamination integrity while optimizing production line efficiency. BFS formation, filling, and sealing can be easily incorporated into a sterile manufacturing process, similar to those required for the production of injectable formulations. The process is highly automated, limiting the risk of microbial or particulate contamination from human intervention. The container only needs to be formed immediately before use and is sealed as soon as it is filled, with no need for an additional manufacturing stage for a closure to be applied. This helps simplify and shorten the production line further while maintaining optimum integrity against contamination.

Support cost-effective clinical and commercial manufacturing at any scale. The process of forming the containers only as they are needed supports high-volume commercial filling, as well as small-batch finishing for clinical or small-scale commercial needs. BFS removes the need for pre-treatment of the container and a separate set of equipment for applying closures, streamlining the filling process. Logistics is reduced considering pallets and materials to move vials from suppliers to fill/finish provider and then into the market.

Offer design flexibility. BFS containers can be made in a uniquely wide range of shapes and sizes, enabling them to easily meet the specific dose or even administration needs of individual drug products. Containers shape can be adapted to consumer needs and by simply having the right molding cavity to manufacture the final container.

Eliminate the need for preservatives. BFS containers can be specifically designed for single-use—with no need for a reclosable closure. For unidose formats relying on BFS containers, there is no need to use preservatives that could affect the drug product’s quality or safety. Mitigating the need for preservatives could also help to reduce the development time frame for the drug formulation.

Reduce the risk of drug waste. As the BFS container is made of plastic rather than glass, there is less risk of breakage during transport, helping to reduce waste from damaged dose units. BFS containers that are designed for unidose applications can minimize waste from expired formulations that might be left in multi-use containers.

Read the article in the Partnerships for Outsourcing eBook.

About the author

Vincenza Pironti, PhD,is strategic marketing director at Recipharm.

Article details

BioPharm International®
Partnerships for Outsourcing eBook
May 2024
Pages: 8-11

Citation

When referring to this article, please cite it as Pironti, V. Leveraging Blow-Fill-Seal Technology for Biologic Delivery. BioPharm International Partnerships for Outsourcing eBook, May 2024.