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www.biopharminternational.com Partnerships for Outsourcing eBook May 2024 BioPharm International ® 11 Manufacturing With all of this in mind, BFS presents a particularly attractive offer for companies developing a new bio- logic or vaccine. The technology can support meeting sterility requirements while allowing biotech projects to benefit from filling efficiency benefits. It is also possible to harness BFS for use in small-scale filling, (e.g., for advanced therapy medicinal products and cell and gene therapies, which traditionally pose efficiency challenges when using other container types). New technologies, new solutions To ensure biologics and vaccine projects benefit from the advantages of BFS technology, it is necessary to consider several aspects. Developers and manufac- turers must ensure that the plastic used to form the container is compatible with the formulation, show- ing effective drug stability and demonstrating ac- ceptable extractable and leachable profiles. The temperatures used in the BFS process must also be factored in. Traditionally, BFS has required high temperatures to form the container and to seal it post-filling. Such temperatures could negatively affect the stability of the biological formulation—an issue that has limited the appeal of BFS to biophar- maceutical companies in the past. However, advances such as new container materials, the introduction of water-based mold cooling, and other steps mean that the BFS process can be performed at tempera- tures cool enough to safeguard the effectiveness of biologics and vaccines. To ensure the BFS process is suitable for biologics filling, it is necessary to consider the following pa- rameters that could affect final product temperatures: • Grade and type of polymer—some polymers re- quire a thicker container wall, which may retain heat for longer. • Extrusion temperature. • Temperature of cooling water for the mold. • Cooling cycle time. • Te m p e r a t u r e of t he a i r or g a s u s e d i n t he blow-molding process. • Ambient temperature. • Size and shape of the finished container—the larger the container, the thicker the container wall must be for strength, slowing the cooling process. The three most important factors that need to be controlled to ensure filling takes place at an accept- able temperature to ensure formulation stability are: • temperature of the container immediately before filling • temperature of the formulation immediately be- fore filling • whether the filled container continues to warm up post-filling. If the temperature of either the formulation or container is too high at the point of filling, then the finished dose may well persist at a temperature range that may destabilize the formulation. Solutions allowing effective BFS use for biologics With advanced and specialist infrastructure and ex- pert support, it is possible to create an effective and scalable low-temperature BFS process perfectly de- signed for biologics and vaccine projects. In particular, temperature monitoring throughout every step can help ensure the filling is perfectly timed and controlled to keep the formulation within accept- able temperature ranges. For instance, thermocouples attached to the mold itself can allow monitoring of the BFS container temperature post-forming. Probes within the units containing the formulation or in- frared bulk temperature monitoring can also allow operatives to gauge whether the formulation is cool enough for filling. All this enables the cycle time between molding and filling to be adjusted according to the needs of the drug product, without any impact on productivity. As such, the filling of biologics can be carried out at a commer- cial scale, from large batches to small batches. The value of expert partnerships Technological improvements have brought signifi- cant progress to BFS manufacturing, allowing it to be suitable for biologics and vaccine projects. A deep understanding of the biologic that needs to be filled is vital to ensure the BFS process is fit for purpose and suitable to streamline the broader manufactur- ing and filling procedure. Developing this understanding can be a challenge for pharmaceutical companies that are considering BFS for the first time, particularly for biopharmaceu- tical formulations. With this in mind, it is important to partner with contract development and manufac- turing organizations that specialize in BFS filling. By working with partners with years of experience supporting drug developers in utilizing the BFS process for biologics and vaccine projects, biotech companies can be confident they have the expert support they need to harness the technology to its full potential. References 1. Blow Fill Seal (BFS) Technology Market, https://www. futuremarketinsights.com/reports/blow-fill-seal-tech- nology-market (accessed July 8, 2023). 2. Visiongain. Visiongain Publishes Biologics Market Report 2024-2013. Nov. 20, 2023. https://www.vision- gain.com/biologics-market-report 3. Market Reports World. Global Vaccine Technologies Market Insights, Forecast to 2029. marketreportsworld. com. https://www.marketreportsworld.com/enquiry/ request-sample/25166870 Q