Transport to manufacturing plant
Isolate, engineer & expand t-cells
Put car t-cells in protective shell
Transport cells back to patient
Infuse patient with car t-cells
Frozen liquids need to be transported from A to B… we enable it!
With the use of our technology, biopharmaceutical companies in the area of Cell and Gene Therapy (CGT) and Personalized Medicine can minimize the risk of bio contamination, manipulation or product loss towards 0%. For CGT many small batches of either buffer salts, primary cells or media, such as CAR-T, are supplied and delivered between biopharmaceutical companies, biotech companies, CMOs, CDMOs, hospitals and other suppliers.
In early stage clinical studies the volume of drug substance is very small, within a range of 1 ml to 500 ml. This process builds upon industry standards like single use bags of all sizes and manufacturers. Scale-down to one single drop of drug substance! RoSS.KSET offers the protection for drug substances between 1 ml to 500 ml. For anything above, RoSS can protect one or multiple small single use bags in one shell.
Furthermore, we offer a framework of preventive and protective measures for this standard that reach a new and unrivaled quality level. Our development features all strengths of single use bags. Potential weaknesses and risks, like material deficiencies or sensitive outer shells, are 100% compensated by our developments.
We call our process CGT.STREAM.
Fill / Drain
Freeze / Thaw
Store & Ship
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.
Fill / Drain
With RoSS.FILL, the RoSS shell systems contained in the rack are filled at high speed in a fully automated manner. Single use bags with smaller volumes less than 500ml can be attached limitless and are compatible with all bags, bottles, connectors and manifolds.
RoSS.FILL Bottle Rack
The control unit of RoSS.FILL can easily be attached to a bottle filling rack – maintaining the advantages of accurate, fast and configurable filling of biopharmaceuticals. Multiple racks can be attached for limitless scalability.
RoSS.FILL base unit with one weighing cell for filling smaller volumes of biopharmaceuticals in multiple single use bags, bottles or vials.
Freeze / Thaw
RoSS.pFTU lab scale
Controlled freezing and thawing of small batches – more important than ever for cell & gene therapies! 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 5l. GMP-compliant computerized system optional.
RoSS.pFTU large scale
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. RoSS.pFTU Large Scale is completely adapted to RoSS shell system for a batch size of 200l and more.
Store & Ship
The basis is higly dense stainless steel. Compact, lockable, freezable, sealable and protecting against manipulation: CGT.RACK offers space for several RoSS.KSET units and is developed for fixed placement in shippers by established manufacturers. The entire system is designed to withstand temperatures of up to -200°C/ -328°F.
RoSS.SHIP Single Use
RoSS.SHIP offers the your tailored solution for 100% protection from external mechanical influences for RoSS shell systems. Different possible sizes will fulfil your individualized need. With passive cooling, it maintains its ultracold temperatures for international shipments over multiple days. With its measurements it complies with international logistcis standards. Also monitoring temperature and tracking its location is no problem.