Why security of supply matters
The reliable supply of biological-based medicinal therapies is highly dependent on a robust, well planned, and risk-managed supply chain. Therefore, business continuity management has become a critical discipline of suppliers in the bioprocess industry. Their goal is to deliver products and services that incorporate risk-mitigating supply chain controls and have a high degree of supply assurance and resilience to supply disruptions.
Single-use technologies continue to see rapid growth and adoption in clinical and commercial biomanufacturing processes where speed and flexibility are desired. Along with these advantages, the shift toward single-use processing creates a paradigm shift for these manufacturers. Their ability to maintain supply becomes increasingly reliant on external suppliers as equipment shifts from batch-to-batch maintained stainless steel systems to disposable ones, which must be procured, delivered, released, and installed for each batch startup. Single-use bags for bioreactors, mixers, culture media, and process fluids are all manufactured from polymer-based films that make up the vast majority of the single-use system’s product contact surface area. In this context, the supply assurance of bioprocess systems and the therapies they produce are dependent on the secure supply of bioprocess film. These realities explain why biomanufacturers rely on supply control and assurance throughout the single-use bag supply chain — from film raw materials to manufacturing into film and, eventually, to the delivery of finished bioprocess systems.