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10 BioPharm International ® Partnerships for Outsourcing eBook May 2024 www.biopharminternational.com Manufacturing 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 addi- tional manufacturing stage for a closure to be applied. This helps simplify and shorten the pro- duction line further while maintaining optimum integrity against contamination. • Support cost-effective clinical and commercial manufacturing at any scale. The process of form- ing the containers only as they are needed supports high-volume commercial filling, as well as small- batch finishing for clinical or small-scale commer- cial 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 mate- rials to move vials from suppliers to fill/finish pro- vider 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 con- sumer needs and by simply having the right mold- ing cavity to manufacture the final container. • Eliminate the need for preser vatives . BFS containers can be specifically designed for sin- gle-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. Miti- gating 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 con- tainer 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 applica- tions can minimize waste from expired formula- tions that might be left in multi-use containers. Navigating an evolving BFS landscape Although BFS technology has been available for many years, the array of drug products being filled into BFS containers is expanding due to an evolving drug mar- ket. BFS is being increasingly considered for biophar- maceutical drug products, and vaccines in particular, due to the rapid growth of this market over the past decade—an expansion that is showing no sign of slow- ing. Estimated to have been worth $447 billion in 2023, the biologics sector is projected to grow at a compound annual growth rate (CAGR) of 8.5% during the fore- cast period 2024–2034 (2). The global vaccine market, meanwhile, is forecast to grow from $48.4 billion in 2023 to $66.8 billion by 2029, at a CAGR of 5.5% (3). Most biologic and vaccine formulations are inject- able, due to their instability through the oral route and the challenges of ensuring they reach the site of therapeutic action. As injectables bypass the body's natural defence mechanisms in the gastrointestinal tract and pulmonary systems, they must be manu- factured in a sterile environment to protect the pa- tient from infection via microbial contamination. This makes BFS a highly appropriate container for the needs of such formulations. The decision to select BFS over other container t y pes for biologics depends on several factors. In particular, if the finished doses need to travel long distances or be filled in a cost-effective unit dose for- mat, then BFS is an ideal choice. Expert advice can help pharmaceutical companies determine whether BFS is an appropriate solution for their therapeutic. The challenge of utilizing BFS for biologics Biologics present several manufacturing and filling issues that developers and manufacturers need to re- solve to provide safe and stable therapies to patients. Being inherently less stable than small molecules— especially in solution—biologics and vaccines require careful handling to maintain their viability. Many biologics are intrinsically sensitive to higher temperatures as the chemical bonds that hold these complex molecules together can be relatively weak. As a result, biologics can be susceptible to degradation and aggregation if they are exposed to stressful physi- cal conditions that can be applied throughout fill and finish, such as high temperatures and shear forces. Consequently, terminal sterilization, the process of sterilizing a drug product with moist heat after the formulation and filling process, is often not a suit- able option for biologics. Instead, many biologics will require sterile filtration before aseptic filling into a sterilized container. Technological improvements have brought significant progress to BFS manufacturing.