FREEZE-THAW PLATFORM / FREEZE & THAW

Freeze & thaw process on a new level.

 

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 datasheets for all RoSS.pFTU sizes in the download area.

 

3 liters / pre-clinical or Phase 1/2

150 liters / Phase 2/3 or commercialized

300 liters / commercialized

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 croyconcentration.

plate freezer
“fast freezing”

A homogeneous freezing image can be seen, no dark blue spots are visible.



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We see issues with integrity of Single Use Systems in the biopharma world. Potentially, the MITS.2D technology is able to help address Endotoxin and Bioburden issues properly. Sterility is key for some applications very close to the patient in Fill and Finish facilities. Midterm, MITS.2D might be able to mitigate the risk of biocontamination in these process steps also.

FDA

FDA authority, USA

We were looking for a solid shipping solution for our single use bags. None of the available solutions to date offered reassuring solutions.
Thanks to a fortunate coincidence we got in touch with SUSupport. Not only have we found a more than solid solution for our main problem thanks to their product RoSS® but we now have access to a clever and 100% safe drug substance logistics system.

Program Manager

Lonza AG, Basel

We were analyzing different solutions on the market for freezing and thawing our drug substances in single-use bags.
The combination of a bag agnostic robust secondary packaging RoSS and the scalable plate based freeze/thaw technologies convinced us to select Single Use Support.
It not only matches all our requirements, it is also safe, easy to navigate and flexible to single-use bags from any supplier.
Furthermore, it is a good starting point to expand to a whole end-to-end solution.

Program Manager

3S Bio
Download

Click here to download technical product datasheets.



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.