New single-use bag family Flexsafe

Its completely new developed product family Flexsafe enables theimplementation of single-use bioprocessing throughout all steps of drug manufacture, fromprocess development to production, in upstream and downstream – all using just the oneinnovative polyethylene film. The innovative concept of the Flexsafe family addresses key industryrequirements for future-proof single-use manufacturing of commercial vaccines and drugs.

Flexsafe is based on a multilayer, proprietary polyethylene (PE) film, called S80, and has beendeveloped in close collaboration with resin and film suppliers. A standardized cell growthassay 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 celllines. The optimization of the resin formulation, the complete control of raw materials, theextrusion process and the bag assembly guarantee lot-to-lot consistent cell growthperformance. With its robust 400 ?m thick PE film, Flexsafe is the strongest and most flexiblebag currently on the market. The bags enable safe and easy-to-use operation, even in themost demanding applications such as liquid shipping and large-scale stirred bioreactors.

Furthermore, batch-to-batch consistent extractables and leachables profiles support drugmanufacturers throughout the entire lifecycle of modern biological treatments from clinicaldevelopment to commercial supply many years after launch. Users can gain assurance thattheir initial extractable and leachable qualification work and data remain valid every timethey operate their single-use Flexsafe bioprocess.

Assurance of supply, one of the most important aspects for manufacturers, is guaranteed as aresult of long-term contracts with suppliers and business continuity plans with defined safetystocks and global manufacturing capabilities including resin manufacturing.

„Flexsafe represents a completely new generation of single-use bags. They offer our customersconsistent cell growth as well as extraordinary robustness and flexibility. In addition asustainable supply chain and consistent film throughout the entire manufacturing process isguaranteed. Every single one of these benefits sets a new benchmark. Being unique in all ofthem makes us very proud”, stated Stefan Schlack, Senior Vice President Marketing andProduct Management at Sartorius Stedim Biotech.

Sartorius Stedim Biotech is launching Flexsafe RM bags (1L-200L) and small bags for validationpurposes 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.

Contact:

Dominic Grone

Group Corporate Communications

Sartorius AG

Goettingen

Phone:+49.(0)551.308.3324

email: dominic.grone[at]sartorius.com

web: www.sartorius.com