CELL THERAPY

Cell Therapy fluid management solutions
Cell therapies have revolutionized the way medicine approaches the treatment of various diseases that have long been believed to be incurable. With many treatment approaches discovered already and a lot more to be found in the course of the several clinical trials that are being conducted, cell therapies entail unforeseeable opportunities within the healthcare sector.
Single Use Support continues to innovate a wide product portfolio of single-use solutions for cell therapy that incorporates all steps of cell therapy manufacturing – from the primary packaging and fluid management solutions up to ultra-cold and cryogenic freezing, storing and shipping options, ready to meet regulatory requirement such as the FDA.
"Bestcellers": Controlled Filling & Freezing of Cells
Sterile aliquoting into single-use bags and freezing for cryopreservation of cells pose challenges for laboratories and manufacturers. Download the App Note to learn more about the implications and approaches to address these challenges.
Primary packaging for cell therapy products
Dedicated primary packaging solutions carry cell therapy products during transfer of liquids in order to provide the highest possible protection. Since the steps within their supply chain include the storage at ultra-cold or even cryogenic temperatures, packaging solutions must be extremely durable, but also space-efficient, considering that efficiency is one of the key considerations for temperature-controlled storage and transport.
This is why we provide manufacturers with packaging solutions for cell therapy products in different sizes, suitable for bulk production, but also for smaller volumes – for the latter of which we offer RoSS.KSET, a protective shell for small single-use bags as they are used in cell therapy. For larger volumes, on the other hand, RoSS-Shell is a suitable packaging option for safe transport and storage of biologics.
Solutions
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Protection for small single-use bags | ROSS.KSET
RoSS.KSET offers protection for small single-use bags. Most suitable for small batch sizes. Smart protection for single-use bags with volumes less than 250 mL in cell and gene therapy or clinical studies.
Bag independent
<0.001% product loss
Best freezing result
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2D bioprocess container | IRIS Bag
Innovative. Robust. Individual. Single-Use. Make sure your supply chain is uninterrupted. Get your IRIS 2D single-use bioprocess container from Single Use Support in any size with the fastest possible delivery times. Store and ship anything from c...
Sizes from 20mL-10L
Freezing to -85°C
Reliable partner
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Protecting single-use bags | RoSS® Shell
The safest transport solution for all available single-use bioprocess containers. Protect your single-use bag and reduce product loss towards 0%. RoSS®: Robust Storage & Shipping
Bag independent
<0.001% product loss
Best freezing result
Aseptic dispensing – fluid management in cell therapy
Once a cell therapy product is ready to be packed, it is vital for it to be filled and subsequently drained under sterile conditions, as contamination of the respective product must be avoided at all costs. Single-use technologies in cell therapies offer a variety of advantages when being relied on in liquid management, making the filling and draining process both safe and cost-efficient.
Our modular single-use fill and filtration platform solutions RoSS.FILL allow for automated aliquoting and a seamless workflow, being fully customizable with a wide range of single-use assemblies to meet our clients’ individual requirements. In combination with our bioprocess containers, a safe and more efficient production process enables optimized cell therapy liquid solutions.
Solutions
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Aseptic cell filling system | RoSS.FILL CGT
RoSS.FILL CGT is a fully automated aseptic cell filling system that allows multiple small single use bags to be filled simultaneously. With its high filling accuracy, the system is special designed for use in cell & gene therapies for up to 12...
Highest accuracy
Down to 1mL/Bag
Integrated sealing & perforation
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Biopharma fluid transfer | IRIS Single-Use Assemblies
As an expert in single-use solutions, we have made it our goal to deliver vendor agnostic single-use assemblies manufactured at highest quality standards in ISO 7 cleanrooms and sterilized within shortest lead times. Prevent downtime and ensure an...
100% customizable
Dual sourcing
GMP-compliant
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Aseptic filling for laboratories | RoSS.FILL Lab Scale
Fully automated aseptic filling platform at smallest footprint with state-of-the-art technology for highest accuracy to fill up to 12 single-use bags in standard configuration. RoSS.FILL Lab Scale is therefore most suitable for filling small volum...
Down to 1mL/Bag
Highest accuracy
Integrated sealing & perforation
Controlled freeze and thaw processes for cell therapies
Cell therapy products usually need to be kept viable ex vivo before they are administered. In order to prevent them from deteriorating, they are in need of adequate freezing and thawing technologies. This is why we have designed the controlled rate cryogenic freezer RoSS.LN2F and the freeze and thaw platform RoSS.pFTU, based on plate freezing, that allows fast and efficient processes. The relevance of such devices becomes even more obvious with regard to the effects that the freezing rate has on the quality of a respective liquid.
As each cell type has its own characteristics in terms of storage temperature, too (which are to be precisely met, and variations in temperature are to be avoided), specialized storing devices need to be put into place as well. Therefore, we from Single Use Support do not only provide freezing and thawing platforms, but also RoSS.FRDG – an ultra-cold storage freezer that is able to maintain temperatures as low as -80 °C.
Solutions
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Ultra-low temperature storage freezer | RoSS.ULTF
RoSS.ULTF is an upright ultra-low temperature storage freezer for frozen drug substances in different sizes. The ultra cold storage freezer keeps the desired set point temperature down to -80°C. It is compatible with RoSS Shells to protect your b...
Down to -80°C
Capacity for up to 300L
Modular Interior
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Cryogenic freezer | RoSS.LN2F
RoSS.LN2F is a powerful cryogenic controlled rate freezer for cryopreservation down to -170°C. An enclosed and innovative platform system for dosed freezing for cell and gene therapies eliminates direct exposure and the need for mechanical compres...
Increased cell viability
Down to -170°C
Down to < 250mL/ Bag
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Laboratory freezer | RoSS.pFTU Lab-Scale
Single Use Support's plate-based laboratory freezer is the perfect solution for clinical studies conducted in labs and, above all, if you want to start a controlled, cGMP-compliant and scalable freezing & thawing process. The system is compati...
Down to -80°C
Controlled freeze-thaw
Up to 10L
Cell therapy solutions for a safe transport
When a cell therapy product is finally ready for transport and due to be shipped, protective measures must be taken in order to prevent it from potentially harmful impacts, such as exposure to temperatures that would affect the cold chain. Additionally, great effort must be put on making the transport as efficient as possible.
Hence, storage density is key. This is why we have developed RoSS.SHIP – a smart cold chain shipping container that is easily stackable and ready to maintain temperatures below -60 °C for at least six days.
Solutions
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Cold chain container for drug substances | RoSS.SHIP
RoSS.SHIP secures the cold chain storage and shipping of bulk drug substance for almost one week. With its Smart Tracking & Tracing Add-on you never loose control of your product. Highly robust, stackable, coolable and compact – RoSS.SHIP co...
Below -60°C for at least 6 days
Track & trace 24/7
Up to 55 RoSS® shells
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Stainless steel rack for RoSS® shells | RoSS.RACK
RoSS.RACK is a supporting device for storage and international shipping of up to 30 RoSS® shells. It is available in different sizes as single-use or multi-use rack. The multi-use rack is made out of stainless steel, and therefore suitable for th...
Up to 30 RoSS® shells
Suitable for cleanroom
100% customizable
More Information

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Small batch manufacturing & fill-finish in cell and gene therapy
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Single Use Support awarded "Solution Provider of the Year 2022"
Single Use Support bags another trophy for innovation and was awarded "Solution Provider of the Year 2022" by Onco Cell Therapy Summit USA 2022 in Boston, MA. The judges honored Single Use Support's end-to-end process solutions for filling-drai...