Freeze-Thaw Platform

The Single Use Support freeze-thaw platforms make insular solutions for the freeze/thaw processes of each clinical phase. 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.


What 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. Freeze & Thaw of vials, bottles and single use bags possible.

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 or blockbuster scale. From 10ml up to 50l bags and a batch size of up to 200L and more you can scale-down or scale-up as required.

Safety

Safe and controlled freezing of high-value biopharmaceuticals will be pushed to a new 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 biopharmaceuticals.

Scalable solutions

RoSS.pFTU lab scale

Compatible with single use bags of all sizes and manufacturers

Our lab scale freezer is the perfect solution for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process. Watch video

  • Single Use Bag independent: any bag vendor, any size
  • Freeze-thaw unit adapted to designed RoSS shells, protecting your preferred single use bag
  • 5L load: either in one 5L bag or multiple small bags
  • Hybrid: Freeze-thaw of vials and bottles possible too
  • Scale-down: best product stability results for CGT, mABs, etc
  • Scale-up: Freeze-thaw recipe for lab scale also transferable for large scale
  • GMP-compliant, automated, at highest possible speed and accuracy
  • Freezes down to -80°C
  • Rental option for your test drive

RoSS.pFTU mid scale

Compatible with single use bags of all sizes and manufacturers

  • Single Use Bag independent: any bag vendor, any size
  • Plate-based Freeze/thaw unit designed for RoSS shells, protecting your preferred single use bag
  • Up to 70L load with either multiple small or up to 5 large single use bags of 20L
  • Hybrid: Freeze-thaw of bags and bottles in same platform
  • Most suitable  for late phase studies, commercial production and thawing of smaller batches
  • Best product stability results for your biopharmaceutical
  • GMP-compliant, automated, at highest possible speed and accuracy
  • Freezes down to -80°C

RoSS.pFTU large scale

Compatible with single use bags of all sizes and manufacturers

Our large scale freezer is a plate-based freeze-thaw unit for any scale and batch sizes. Watch video

  • Single Use Bag independent: any bag vendor, any size
  • Freeze/thaw unit adapted to designed RoSS shells, protecting your preferred single use bag
  • Up to 200L load with different sizes of single use bags
  • Hybrid: Freeze-thaw of bags and bottles in same platform
  • Scale-up for late phase studies or commercial production
  • Best product stability results for mABs and BDS
  • GMP-compliant, automated, at highest possible speed and accuracy
  • Freezes down to -90°C
Freeze overview different scales

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.



What are the advantages of this FREEZE-THAW PROCESS?

The plate-based freezing and defrosting facilities RoSS.pFTU by Single Use Support is continuously developing and establishing on the biopharmaceutical industry due to its convincing advantages in scalability, single use bag independence, proven product stability and freezing performance in speed and accuracy.

Safety and constant freezing of high-quality substances in an even shorter timeframe will be pushed to a new level – a further milestone for the biopharma manufacturers.

The scalable solutions for freezing and thawing ranges from the RoSS.pFTU lab scale to RoSS.pFTU large scale.

RoSS.pFTU blockbuster aspires to replace CryoVessels, which are used for very large batch sizes, in the single use variant. Its development is currently in its final stage.

Find data sheets for all RoSS.pFTU sizes in the download area.

Freeze & Thaw for CGT lab scale

Compact freeze & thaw unit for small batches.

Monitored freezing and thawing of small batches – more important than ever in times of CGT cell therapies and Seed Train Intensification!

Our experience with the Bulk.Stream® – as well as from developing our compact freeze & thaw facilities for labs and research institutions – forms the basis for the RoSS.pFTU lab scale system. RoSS.pFTU lab scale is the perfect solution for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process.

Another milestone towards more patient safety!

Facts:

  • Benchtop lab scale freeze and thaw platform
  • Compatible with single use bags of all manufacturers and sizes
  • RoSS shell and RoSS.KSET can be used for freezing
  • Freezing at highest possible speed & accuracy
  • Ensures best product stability results
  • Lab scale freezes drug substance volume from 1 mL to 5 L per bag

How to achieve scalable freezing & thawing of biopharmaceuticals

Scalability around freezing means the ability to guarantee constant stress on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios.
Single Use Support fulfils this requirement by standardizing the IFGS – icefront growth speed – for all possible scenarios regardless of the filling volume and type of bags but also regardless of the type of system, i.e. whether LabScale, MidScale or LargeScale.

Scalable bulk drug substance process - Micro to macro - from lab to commercial scale

Batch size volume and load independent controlled freezing and thawing results:

Controlled freezing and thawing with all bag sizes – from 3 liters to 300 liters. Example of freeze/thawing curves of a fully scalable process

3 liters / pre-clinical or Phase 1/2

Small scale Pall bags freeze thawing

150 liters / Phase 2/3 or commercialized

300 liters / commercialized

After-Sales Premium Service

Virtual remote assistance in after-sales service

Fastest service to count on for all freeze & thaw platforms.

  • Priority access with visits from a service engineer from Single Use Support within 24 hours in Europe and 72 hours globally
  • 24/7/365. Single Use Support is available anytime, all the time.
  • Virtual connection with a remote access module.
  • Virtual glasses with live quarterly performance checks such as with Hololense
  • Annual Preventative Maintenance
  • Customer Training for continued learning by maintenance team
  • Tailored toolbox for customers’ technicians
  • Spare Parts Benefits at discounted price
After-Sales Premium Service Package / Single Use Support
After-Sales Premium Service Package by Single Use Support

Freeze-Thaw Platform RoSS.pFTU lab scale

Freeze-Thaw Platform RoSS.pFTU Lab Scale

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

Freeze-Thaw Platform explainer video

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.

Freeze-Thaw Platform RoSS.pFTU large scale

Freeze-Thaw platform RoSS.pFTU_large scale form Single Use Support

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.

FAQ

Yes, there is a huge benefit of using a plate freezer. The benefit of a plate freezer is that the freezing process can be controlled very accurate, and it is independent of the amount of shells you put inside the plate freezer.

Freeze/Thaw Platform: The perfect single use solution for freeze&thaw processes

Throughout the various clinical phases, the batch sizes for drug substances are getting progressively bigger. While the initial volumes may be double-digit and less, they will grow to several hundred and finally some thousand liters.

Would this not be reason enough to use a flexible freeze-thaw technology for all phases that is compatible with any established single use bag?

At Single Use Support we have found the perfect solution: Our new freeze-thaw platforms make insular solutions for the freeze/thaw processes of each clinical phase. 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.

In other words, you will only require one single technology all the way from preclinical phases to the final production of blockbusters, namely, the freeze/thaw platform developed by Single Use Support. It offers you the advantage of not having to commit to a specific bag and not having to change the system when entering the next phase.

What are other advantages of the Single Use Support freeze-thaw platform?

The freeze-thaw units developed by us allow you to freeze and thaw drug substances in the shortest time possible. High-quality liquids are not only frozen much quicker but also more constantly in order to maintain their nature.

The advantages at a glance:

• compatible with all single use bags of established manufacturers
• fully scalable
• one system for all clinical phases as well as blockbuster production
• fast and constant freezing
• high degree of patient safety

For preclinical studies and small batches, we have developed RoSS.pFT, a compact freeze-thaw unit for small volumes of liquid as well as CGT and BDS tests. It is compatible with all established bags, thus allowing full scalability.

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. The platform is the perfect freeze & thaw single use option as it is compatible with single use bags from all established manufacturers as well as with different sizes and volumes.

RoSS.LSSP is our large freeze and thaw unit for “bulk drug substance” of up to 300 L in a single unit. This freeze & thaw platform for large batch sizes will soon replace the Cryovessel as the option of choice for single-use containers.