Freeze-Thaw platform

The Single Use Support freeze-thaw platforms provide reliable end-to-end solutions, such as plate freezers for the controlled freeze/thaw processes of any drug substance - either for clinical phases or commercialized bulk production. 

Our new freeze-thaw units are fully scalable and compatible with all batch sizes and bags from all established manufacturers – you will only require one single system from the lab to blockbuster production.

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Plate freezer for biopharma - scalable freezing with RoSS.pFTU by Single Use Support
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RoSS.pFTU Lab Scale Benchtop | Plate Freezer

Plate freezer RoSS.pFTU Lab Scale Benchtop is the easy-to-implement platform system for labs to perform freezing of small volumes in 2D single-use bags for clinical studies, clinical trials and cell and gene therapies.

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Laboratory freezer RoSS.PFTU Lab Scale

RoSS.pFTU Lab-Scale | Plate Freezer

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.

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RoSS.pFTU Mid-Scale | Plate Freezer

Up to 100L: Our mid scale freezer is a plate freezer and thaw unit designed for RoSS shells, to protect your preferred single-use bag during cryogenic applications. 

RoSS.pFTU mid scale is compatible with single-use bioprocess containers of all sizes and manufacturers and shows best product stability results for your biopharmaceuticals up to 100L. 

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RoSS.pFTU Large-Scale | Plate Freezer

Up to 400L: Our large scale freezing platform system is a plate-based pharmaceutical freezer and thaw unit for any scale and batch size. Well-established RoSS.pFTU large scale is compatible with single-use bags of all sizes and manufacturers. The hybrid solution offers freeze-thaw capabilities for bags and bottles up to 400L in one platform.  

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RoSS.pFTU Large-Scale Hybrid | Plate & Blast Freezer

The Hybrid Freeze and Thaw Platform freezes and thaws larger volumes of drug substances in both single-use bioprocess containers and bottles all in one. RoSS.pFTU large scale with its hybrid option is compatible with single-use bags and bottles from all manufacturers and of all sizes up to 400L and beyond.

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RoSS.pFTU XL | Freeze-Thaw

Controlled freezing and thawing of thousand of liters in biopharmaceutical  manufacturing processes. Automated plate-based freeze-thaw unit for 500 liters per batch of any liquid substances including vaccines, media, buffer solutions or other drug substances.

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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.

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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.

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RoSS.FRDG Plus | Portable Ultra Cold Storage

RoSS.FRDG Plus is a portable ultra-cold storage freezer for frozen drug substances. The flexible freezer offers a range of set point temperature between -80°C and +8°C. 

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RoSS.PADL | Cooling & Homogenizing

RoSS.PADL is a scalable platform for cooling your single-use bag whilst gently massaging it to ensure there is a homogenous mixture of the solution. With the RoSS.PADL multiple cooling and massaging mechanisms can be placed side by side with one control system.

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ROSS.SHAK | Shaker

RoSS.SHAK is your reliable shaker to regain highest quality and homogeneity of your biopharmaceuticals.

RoSS.SHAK enables constant shaking of your protein to regain homogeneity and product quality after freezing. Shakes up to 70L per run in 3 pre-defined speeds.

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RoSS.LODR open loading single-use shell

RoSS.LODR | Foldable gripper arm

RoSS.LODR is a mobile and foldable gripper arm that ensures ergonomic handling during loading or unloading activities. RoSS.LODR supports a safe working environment and can significantly reduce work related repetitive strain injuries.

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Our customers trust in us:

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Fujifilm Diosynth

Lonza

Moderna

AGC Biologics

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Whats makes the Freeze-Thaw platform so special?

Fully automated

Fully-automated freeze & thaw process, at highest possible speed and accuracy. CFR Part 11 and GMP-compliance as a further milestone for the biopharma manufacturers. Freeze/thaw recipe for lab scale also transferable for large scale.

Flexibility

Compatible with single use bags of all established manufacturers, sizes and capacities. Hybrid version to freeze & thaw vials, bottles and single use bags in one platform possible. Or upgrade to LN2 freezing down to -180°C.

Unrestricted Scalability

The scalable solutions for freezing and thawing ranges from the RoSS.pFTU lab scale to RoSS.pFTU large scale. For CGT or cell culture inoculation using either multiple small bags or up to one 5L bag, there is RoSS.pFTU lab scale. Your way up to blockbuster commercial production is possible with RoSS.pFTU large scale. From 10mL up to 50L bags and a batch size of up to 400L and more you can scale-up or down as required.

Safety

Safe and controlled freezing of high-value biopharmaceuticals will be pushed to a higher level: Tamper-evident closed system with optimal freezing kinetcs leading proven product stability and freezing process with best results for mABs, BDS, CGT, ADCs, viral vectors or any other vaccines.

Scalable freeze thaw system with RoSS.pFTU scalability

Blast vs. Plate based Freeze/Thaw units

We tried to visualize Cryoconcentration by using Naphthol Blue Black as color agent. An in- tense blue coloration shows a high concentration of dissolved solutions. The bags frozen in the plate freezer exhibit a homogenous tinge with a white line running through the center. The bag frozen in the static freezer exhibits higher concentration levels in the lower areas.

blast freezer "slow freezing"

Dark blue spots indicate a higher cryoconcentration

Blast freezer slow freezing

plate freezer “fast freezing”

A homogeneous freezing, no dark blue spots are visible.

Plate freezer biopharma fast freezing of drug substances by Single Use Support
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Data sheets

Click here to download technical product data sheets, design videos, as well as a case studies and more.

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RoSS.FILL - single use filling system for drug substances

RoSS.FILL |Fill-Filtration

RoSS.FILL is a fully automated single-use bag filling system. This allows maximum flexibility and scalability of both the filling and draining process. It is possible to fill unlimited volumes per batch with a speed of up to 300 liters per hour. The entire filling process is fully disposable, thus warranting an absolutely sterile fill & drain process. For further productivity improvements check out our pinch valve innovation.

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MITS.2D | Integrity Testing System

Everything else is like “hoping that all goes well.”
With a patented system, MITS.2D tests single use bags with a capacity of up to 20 liters in less than 60 seconds to make sure they are 100% intact.

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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.

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Videos

Freeze-Thaw Platform RoSS.pFTU lab scale

Freeze-Thaw Platform “RoSS.pFTU lab scale” is a laboratory freezer used  for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process. 

Freeze-Thaw Platform RoSS.pFTU large scale

RoSS.pFTU is our “standard” freeze-thaw platform. It is suitable for different batch sizes and offers a fully scalable solution for medium-sized and large batch volumes.

Freeze-Thaw Platform explainer video

Rapid freezing achieves a far more homogeneous freezing result. Not only can this save 100% of the cells, it’s also way faster than any established freezing processes to date. Single Use Support has developed a so-called “Plate Freezer” for all batch sizes, which makes fast freezing really easy.

Pharmaceutical freezers for safe storage

In biopharma and similar industries related to the healthcare sector there is a lot of talk about the process of freezing with a pharmaceutical freezer: This process brings medical grade drug substances into a frozen state to allow for protected, safe and reliable storage and shipping at low temperature.

It depends on the drug substance at what process steps and at what temperature it needs to be frozen in order not to get degraded. The most recent accomplishments in COVID-19 vaccine clinical trials and the raised discussions of required temperature for storage in vaccine refrigerators and vaccine freezers are solely about the vaccine storage temperature after fill & finish in final syringes and vials. There will still be need to fulfill CDC requirements for ultra cold freezing to -80°C in the bioprocess manufacturing process steps ahead until the vaccine is being filled into syringes and vials for global supply.

However, the medial anxiety about freezing biopharmaceuticals to ultra low sub-zero temperatures in the -60°C and -80°C temperature range has only shown that established technologies do not fulfill high performance industry requirements and are not well-trusted yet. To date, the methods employed in research often involve traditional auto defrost and countertop laboratory freezers and cooling systems that usually are, however, not the most efficient ones.

Freezer for biopharma - freeze-thaw platform

Countless academic research labs utilize dated refrigerator/freezer combinations for flammables and freestanding chest freezers as lab freezers, often without digital temperature display or temperature alarms, and still require manual defrost. Medical-grade refrigerators (e. g. blood bank refrigerators) and medical freezers are usually equipped with thermostats that are calibrated with NIST conforming thermometers and with automatic defrost. 

The utilization of static glass door refrigerators and standard solid door compressor laboratory refrigerators is responsible for up to 56 % of viral potency product loss in biopharmaceutical manufacturing.​ This almost incredible percentage is the result of a slow and inefficient procedure that leads to decreased temperature uniformity and inhomogeneous results.

In highly complex and technically progressive environments brimming with microprocessors and data loggers, with a focus on speed and quality, traditional pharmaceutical refrigerators and freezing processes are, generally speaking, no longer appropriate. They prove to be more and more inefficient as they only slowly drain the heat from the product, thus lacking appropriate temperature control and leading to an inconsistently frozen substance. What is needed are efficient systems based on elaborate, cutting-edge procedures that are tailored to push productivity by freezing biopharmaceutical substances evenly and without any product loss - ultra cold freezer.

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What is required of cutting-edge pharma freezer systems today?

Sophisticated and intelligent freezing system will have to cover three main aspects in order to meet the basic requirements of today’s biopharmaceutical industry:

  1. Preserving the quality of any frozen substance
  2. Facilitating organized and easy storage of drug substances 
  3. Scalability: The client needs to be able to scale both volume and quantity.

These three parameters have to be considered in order for a platform to be relevant for drug substance logistics in labs and manufacturing, both for small batches and bulk production.

Plate freezer for the pharmaceutical industry

RoSS.pFTU: Time-saving freeze-thaw platform based on plate freezers

With RoSS.pFTU, Single Use Support has developed a freeze-thaw platform that addresses the needs of the industry and provides solutions. The system designed by Single Use Support allows for a blast-like freezing where the substance contained in RoSS® is evenly frozen thanks to the direct contact between the plate freezer and the stainless steel plates covering the container: The close contact between freezing plates and liquid substance significantly speeds up the process as it facilitates a direct transfer of the cold. Additionally, there is no ambient air that requires cooling, as is the case with traditional freezers. The homogenous outcome of this plate freezing technology not only maintains the substance’s original quality but also protects it from potential damages during shipping and thawing.

In addition to affording fast and homogeneous results, Single Use Support’s freeze-thaw platform offers additional benefits that merit its use in the biopharma and similar industries:

  • Minimized production costs
  • Maximized production output
  • Easy and simple disposal
  • Reduced power and water consumption

FAQ

What is the difference between a blast freezer and a plate freezer?

While blast freezers use cold air that is blasted on products that are yet to be frozen, plate freezers work via direct contact between the cooled plates and the products.

What is plate freezing application of refrigeration?

The fields of application of plate freezers are manifold, since they are able to deliver a very consistent and fast freezing process. Therefore, they are, for instance, an essential tool in biopharma industry, where the quality of highly delicate products needs to be maintained when bringing them to ultra-low temperatures.

What is a pharmaceutical-grade freezer?

A pharmaceutical-grade freezer is a freezer that is designed to freeze and store pharmaceutical substances – for instance vaccines – in a secure and efficient manner. In order to be able to cope with the high fragility of these products, there are several aspects in which they differ from ordinary kitchen freezers.

How cold are medical freezers?

Medical freezers are designed to maintain set temperatures within a range of usually between -40 and 86 °C, in some cases down to -150 °C.

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Whitepaper: How controlled freezing enables scalability

In a comprehensive study the impact of ice front growth speed on scalability of freezing protein solutions has been evaluated.

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Supplier overview on freeze thaw technology for biopharma

An overview of relevant suppliers: Freeze Thaw in Biopharma

In order to preserve biopharmaceutical properties, bulk drug substances are commonly frozen before they are being stored or sent on their way around the globe. Read more about the players and their innovations!

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Freeze-thaw platform for biopharma

Freeze-thaw platform revolutionizing the drug substance logistics process

With bulk drug substances playing an increasingly important role in the pharmaceutical and biopharmaceutical industry, the need for a reliable freeze/thaw process as well as safe shipping and storage is more important than ever.
 

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Freeze-thaw technology for handlings mAbs on another quality level

Thawing antibodies - Freeze Thaw technology for handling mAbs on a higher quality level

In a field as sensitive as biopharmaceutical development and production, controlled processes and procedures have always played a vital role and will continue to do so. Learn more why Single-use technologies are highly flexible, scalable and on another quality level.

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