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Sartorius Stedim Biotech Launches New Single-Use Bag Family Flexsafe

Sartorius Group
3 Jun 2014
Kerry Parker
CEO

Product news

Sartorius Stedim Biotech, a leading global supplier of the biopharmaceutical industry, is introducing a brand-new, scalable range of single-use bags. Its completely new developed product family Flexsafe enables the implementation of single-use bioprocessing throughout all steps of drug manufacture, from process development to production, in upstream and downstream – all using just the one innovative polyethylene film. The innovative concept of the Flexsafe family addresses key industry requirements 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 been developed in close collaboration with resin and film suppliers. 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.

Resin formulation ensures cell growth performance
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. With its robust 400 μm thick PE film, Flexsafe is the strongest and most flexible bag currently on the market. The bags enable safe and easy-to-use operation, even in the most demanding applications such as liquid shipping and large-scale stirred bioreactors.

Furthermore, batch-to-batch consistent 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 can gain assurance that their initial extractable and leachable qualification work and data remain valid every time they operate their single-use Flexsafe bioprocess.

Assurance of supply, one of the most important aspects for manufacturers, is 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.

"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. Being unique in all of them makes us very proud”, stated Stefan Schlack, Senior Vice President Marketing and Product Management at Sartorius Stedim Biotech.

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.

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Flexsafe Bioprocessing Bags

Sartorius Group

Sartorius has developed a new polyethylene film and bioprocessing bags to facilitate the way towards the single-use facility of the future. Flexsafe meets the most stringent needs for safer bioprocessing. Flexsafe bags ensure an excellent and reproducible growth behavior with the most sensitive production cell lines. The optimization of the resin formulation and the complete control of our raw materials, the extrusion process and the bag assembly guarantee a consistent lot-to-lot cell growth performance.Flexsafe meets your requirements for outstanding robustness and ease of use at all steps of your manufacturing process. The film’s strength and flexibility provide consistent performance and easy handling – even in the most stringent applications like cell culture, long-term storage or shipping of drug products.To meet the highest business continuity requirements, we have a robust contingency plan for our Flexsafe bags in place. The uninterrupted film supply is based on redundant resin crackers, film extrusion lines and multiple manufacturing sites.The complete range of scalable Flexsafe bags enables you to implement single-use bioprocessing throughout all steps of drug manufacture, from process development to production – all using just one film.Features: Optimized antioxidant package - Excellent cell growth of the most sensitive cells Use of pharmacopeia-listed antioxidants only - Simplified toxicology assessment Zero slipping agents - No risk of interference due to these agents Mechanical anti-blocking - Reduces stickiness, facilitates extrusion and bag handling Meaningful specifications and process control from polymer resin to finished bag Reliable and reproducible growth performance, well-characterized extractables profile

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Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Shipping / PackagingPackaging is the technology of enclosing or protecting products for distribution, storage, sale, and use and the process and production of packages. Packaging is closely linked to Shipping and the preparing of goods for transport, warehousing, logistics, sale, and end use. Within the pharmaceutical industry packaging and shipping are used for transport, storage and logistics between Contract Research Organizations (CROs), Manufacturing and Clinical Trial companies. Packaging is also critical in the final production of a pharmaceutical product before market. Scale-upScale-Up is generally defined as the process of transferring the results of the discovery phases of the drug discovery process, obtained on a laboratory scale, to the pilot plant and finally to production scale. Scale-Up uses reactors and pump systems as well as reagents, standards and buffers. Often Scale-Up is provided as a service by Contract Manufacturing Organizations (CMOs). Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.FormulationFormulation is the process of combining active pharmaceutical ingredients with excipients to produce a drug which is both stable and active.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.

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