Sartorius Stedim Biotech is introducing a new scalable range of single-use bags, Flexsafe, for the implementation of single-use bioprocessing at all stages of drug manufacture, from process development to production both upstream and downstream. The innovative concept of Flexsafe addresses key industry requirements for future-proof single-use manufacturing of commercial vaccines and drugs.
Developed in close collaboration with resin and film suppliers, Flexsafe is based on a multilayer, proprietary polyethylene (PE) film, S80. A standardized cell growth assay has been used to optimize film formulation, determine the operating ranges for extrusion, welding and gamma-irradiation processes and to establish specifications and process controls.
Flexsafe ensures excellent and reproducible cell growth behavior of the most sensitive cell lines. The optimization of the resin formulation, the complete control of raw materials, the extrusion process and the bag assembly guarantee lot-to-lot consistent cell growth performance.
Flexsafe offers strength and flexibility with its robust 400 μm thick PE film. The bags enable safe and easy-to-use operation, including applications such as liquid shipping and large-scale stirred bioreactors.
Consistent batch-to-batch extractables and leachables profiles support drug manufacturers throughout the entire lifecycle of modern biological treatments from clinical development to commercial supply many years after launch. Users have the assurance that the initial extractable and leachable qualification work and data remain valid every time they operate their single-use Flexsafe bioprocess.
Assurance of supply is also guaranteed as a result of long-term contracts with suppliers and business continuity plans with defined safety stocks and global manufacturing capabilities including resin manufacturing.
Sartorius Stedim Biotech is launching Flexsafe RM bags (1L-200L) and small bags for validation purposes first. Bags for single use bioreactors BIOSTAT STR (50-2000L) and additional applications such as storage, mixing, shipping freeze and thaw will be rolled out step by step.