Sartorius Stedim Biotech Launches New Single-Use Bag Family Flexsafe
Sartorius Stedim Biotech 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.
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 (1–200L) 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.
Related News
-
News Moderna to buy OriCiro Genomics in USD $85 million deal
Pharmaceutical company Moderna acquires genomics services company OriCiro Genomics, based in Tokyo, Japan, to boost mRNA therapeutics development and manufacturing portfolio. -
News New year, new prices: at least 350 drugs in USA to see price increases in January
Drugmakers such as Pfizer, GSK, BMS, AstraZeneca, and Sanofi are planning to raise prices for at least 350 unique drugs in the United States in early January. -
Sponsored Content 2023 Pharma Trend Outlook: Innovation, Resilience, and Pharma 4.0
Download our 2023 Pharma Trends Outlook report to discover the trends set to shape the pharmaceutical landscape in the new year, with expert opinions and insight from across the pharmaceutical value chain. -
News Strategic partnership between AstraZeneca and G42 Healthcare to increase pharmaceutical manufacturing in Abu Dhabi
A comprehensive, long-term partnership agreement between AstraZeneca and G42 Healthcare is set to enhance local drug manufacturing in Abu Dhabi, UAE, and bolster pharmaceutical manufacturing innovation within the country. -
News CordenPharma joins sustainability initiative to achieve Net Zero
The CDMO has joined the environmental initiative looking to align private sector companies with those aims upheld by the Paris Agreement to reduce global warming. -
News AstraZeneca acquires Neogene in shift into cell-based cancer therapies
AstraZeneca has recently announced that it will be acquiring the biotechnology company Neogene Therapeutics as part of it’s expansion into cell-based cancer treatments.
-
News A mRNA universal flu vaccine is in early stages of development
Researchers from the University of Pennsylvania have developed a universal flu vaccine using nanoparticle encapsulated mRNA. -
News Biovac partnership to increase African vaccine manufacturing capabilities
South African biopharma company Biovac signs a partnership deal with the International Vaccine Institute to develop and manufacture an oral cholera vaccine for both the African and global market.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance