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 liquid management solutions up to ultra-cold and cryogenic freezing, storing and shipping options, ready to meet regulatory requirement such as the FDA.

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Primary Packaging

RoSS.PADL

Feed Source for Aliquotation

Single-use aseptic bag filling machine RoSS.FILL

Automated Aliquotation

Protection for small single use bags CGT with RoSS.KSET

Robust Protection

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Controlled Rate Freezing

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Cold Storage

Shipping drug substances in single-use bag containers safely with RoSS.SHIP

Shipping

Primary Packaging

IRIS Single-Use Bag (2D or 3D)

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.

Single-use bioprocess container by Single Use Support

Feed Source for Aliquotation

ROSS.PADL | HOMOGENIZING SOLUTION

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.

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Automated Aliquotation

RoSS.FILL

With RoSS.FILL, the RoSS shell systems contained in the bag rack can be filled with a speed of up to 300 liters per hour in a fully automated manner. RoSS.FILL is compatible to all single use bags and bottles and can be scaled up by attaching multiple racks.

Cell and gene therapy filling machine with RoSS.FILL CGT system
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RoSS.FILL Lab Scale

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.

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Robust Protection

RoSS.KSET

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.

Industry 4.0 biomanufacturing RoSS.KSET for CGT bag protection
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RoSS® Shell

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.

Bulk.Stream RoSS shell

Controlled Rate Freezing

RoSS.LN2F

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.

Cryogenic Freezer RoSS LN2F
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Lab Scale Controlled Plate-Freezer (-80°C)

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.

Laboratory freezer RoSS.PFTU Lab Scale
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Large Scale Controlled Plate-Freezer (-80°C)

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.

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Cold Storage

RoSS.FRDG | Cold Storage

Ultra-Cold Storage for frozen drug substances in different sizes. RoSS.FRDG keeps the desired set point temperature down to -80°C.

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Shipping

RoSS.SHIP

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.

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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

RoSS.KSET top view

ROSS.KSET | Protecting small single-use bags

RoSS.KSET offers the protection for drug substances with volumes less than 250 mL. The shell of our CGT bag protection system is robust, closed, safe and sterile – most suitable for cell and gene therapies or clinical studies.

For larger volumes, RoSS can protect one or multiple single-use bags in one shell.

Single-use bioprocess container by Single Use Support

IRIS Single-Use Bioprocess Container

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 cell culture samples to large drug substance volumes reliably and on time.

RoSS shell protecting single use bags open

RoSS® Shell | Protecting single-use bags

The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent.

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

Automated filling and draining system for CGT - RoSS.FILL CGT

RoSS.FILL CGT | Fill-Filtration

10mL-500mL: Fully automated cell and gene filling machine system for aseptic filling of multiple small single use bags. Special designed for use in cell & gene therapies with batch sizes at low volumes. With its high filling accuracy, the platform provides filling for up to 36 bags with one rack - having the option to attach more racks.

RoSS.FILL - single use filling system for drug substances

RoSS.FILL Bag | Single-use aseptic bag fill-filtration system

RoSS.FILL Bag is a flexible automated single-use aseptic bag filling machine for dispensing biopharmaceuticals into single-use bags. The fluid path is designed to be fully disposable and is able to accommodate a variety of sterile connection and disconnection options.

Single-use assemblies manifold

IRIS Manifold | 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 uninterrupted supply chain in compliance with GMP and regulatory requirements with our single-use manifold assemblies using silicone tubing and connectors of your choice.

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

Ultra-cold storage RoSS.FRDG

RoSS.FRDG | Ultra Cold Storage Freezer

RoSS.FRDG is an ultra cold storage fridge for frozen drug substances in different sizes. The ultra cold freezer keeps the desired set point temperature down to -80°C. RoSS.FRDG offers highest storage density, is fully movable and can be modularly adapted to your individual needs.

Cryogenic Freezer RoSS LN2F

RoSS.LN2F | Cryogenic Freezer

RoSS.LN2F is a powerful cryogenic controlled rate freezer for temperatures down to -180°C/ -292°F. An enclosed LN2 system and our innovative direct injection system ensure no direct exposure and no mechanical compressors are needed. This ensures a safe, low-maintenance and energy-saving handling.

Laboratory freezer RoSS.PFTU Lab Scale

RoSS.pFTU Lab-Scale | Freeze-Thaw

1mL-10L: Laboratory freezer, compatible with single use bags of all sizes and manufacturers. Our lab freezer is the perfect solution for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process.

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

Single Use Support shipper

RoSS.SHIP | Ship, Track & Trace

RoSS.SHIP secures the cold chain shipping and storing of bulk drug substance for almost one week. Highly robust, stackable, coolable and compact – Fort Knox for high-quality substances!

Store and ship single use container with Ross Trolley

RoSS.RACK | Transport Devices

RoSS.RACKs are supporting devices for in-plant transport for up to 30 RoSS® shells. Racks can be moved easily either on paletts or as trolleys and smoothen the process between various logistics units, such as from filling RoSS® shells to the bulk substance freeze platform.

More information

RoSS.pFTU Lab Scale - in process (1 von 9)-min

App Note: Cell Monolayer Cryopreservation

Advanced cell-based assay workflow with CryoLogyx Thaw and Test pre-plated cell and controlled, scalable freezing process solution RoSS.pFTU to achieve effective cryopreservation of cells.

Small batch manufacturing in fill-finish for cell and gene therapy

Small batch manufacturing & fill-finish in cell and gene therapy

A great example is the treatment of insidious cancers with CAR T-cells, that relies on modifying the patient’s own T-cells to instill them with a targeted way to fight cancer cells. Learn more why forming strong collaborations will solve many issues!

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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.