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.
Primary Packaging
Feed Source for Aliquotation
Automated Aliquotation
Robust Protection
Controlled Rate Freezing
Cold Storage
Shipping
Store and ship anything from cell culture samples to large drug substance volumes reliably and on time. 2D or 3D single-use bioprocess containers in any size.
RoSS.PADL is a platform to standardize cooling of your single-use bag whilst gently massaging it to ensure a homogeneous mixture of your substance.
Accuracy is key: Fully automated platform system for aseptic filling of up to 12 single-use bags in standard configuration and is extendable to higher bag quantities. Most suitable for filling small volumes in cell & gene therapies or seed train intensification.
RoSS.FILL is compatible to all single use bags and bottles and can be scaled up by attaching multiple racks. Fully automated aliquoting into multiple small single use bags at highest accuracy. Applicable for autologous and allogeneic, cell & gene therapies.
Single use bags with a volume of less than 250ml are covered with a first layer of soft 3D foam which is complemented by an innovative and intuitive locking mechanism. Its robust stainless steel frame protects the single use bag during freezing and shipping.
With the RoSS Shell system, the sensitive single use bag is covered in 3D foam, which is held by a highly robust plastic frame. Bottom and top are made of stainless steel – ideal for the freezeing process and absolutely robust.
RoSS.LN2F is a powerful cryogenic controlled rate freezer for temperatures down to -180°C/-292°F. An enclosed and innovative platform system for dosed freezing for cell and gene therapies enables no direct exposure, and no mechanical compressors are needed. This ensures a safe, low-maintenance and energy-saving handling.
Controlled freezeing and thawing of small batches - more important than ever for cell & gene therapies and clinical studies! The plate-based freeze & thaw platform for labs RoSS.pFTU Lab Scale is the perfect solution for one or multiple single use bags of up to in total 10L. GMP-compliant computerized system optional.
The freeze & thaw system RoSS.pFTU is a fully automated and scalable plate-based freezing unit. Both economically and in terms of product stability we have reached the next level. The plate-based platform RoSS.pFTU Large Scale is completely adapted to RoSS shell system for a batch sizes of up to 400L and more.
Ultra-Cold Storage for frozen drug substances in different sizes. RoSS.FRDG keeps the desired set point temperature down to -80°C.
Storage at -80°C/-150°C & shipment. 100% protection from external mechanical influences and different possible sizes will fulfil your individualized need. Also monitoring temperature and location-tracking are no problems.
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.
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.
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.
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.
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.
