CELL THERAPY

Close-up image of a RoSS.KSET with a frozen single-use bag inside.

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.

Preview of Single Use Support's application note about controlled filling and freezing of cells

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App Note: "Bestcellers": Controlled Filling & Freezing of Cells

Explore how modular, GMP-compliant technologies streamline the sterile filling and cryopreservation of cells for therapies, banking, and culture. This application note highlights how Single Use Support’s solutions enable precise aliquotation, scalable freezing down to -150°C, and high post-thaw viability - reducing product loss and manual inefficiencies in cell-based manufacturing.

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.

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.

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.

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.

More Information

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