Full Name: Flexsafe Single-Use Bag Family
Team: Sartorius Stedim Biotech
Status: Active, flexible, single use
Debut: June 2014
Field Position: Process development to production, upstream and downstream
Skill Set: Completely new product family of single-use scalable range bags, Flexsafe enables the implementation of single-use bioprocessing throughout all steps of drug manufacture using just one polyethylene film. The innovative concept addresses key industry requirements for future-proof single-use manufacturing of commercial vaccines and drugs.
• Based on a multilayer, proprietary polyethylene (PE) film, called S80
• Robust 400 μm thick PE film, makes it the strongest and most flexible bag currently on the market
• Ensures excellent and reproducible cell growth behavior of the most sensitive cell lines
Regulatory Profile: Supports cGMP and QbD-based biopharmaceutical processing regimes
Coach’s Notes: “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. Furthermore, batch-to-batch consistent extractables and leachables profiles support drug manufacturers throughout the entire lifecycle of modern biological treatments. Users can gain assurance that initial extractable and leachable qualification work and data remain valid every time they operate a single-use Flexsafe bioprocess. "
Scout’s Notes: “Flexsafe represents a completely new generation of single-use bags. They offer our customers consistent cell growth as well as extraordinary robustness and flexibility. In addition a sustainable supply chain and consistent film throughout the entire manufacturing process is guaranteed. Every single one of these benefits sets a new benchmark …” says Stefan Schlack, senior vice president, Marketing and Product Management, Sartorius Stedim Biotech.
Team Resources: Sartorius Stedim Biotech provides cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions cover fermentation, cell cultivation, filtration, purification, fluid management and lab technologies support the biopharmaceutical industry around the world develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech fields manufacturing and R&D sites in Europe, North America and Asia, employs approx. 3,000 people and in 2012 earned sales revenue of 544 million euros.