FREEZE-THAW PLATFORM / FREEZE & THAW

Freeze & thaw process on a new level.

 

It is no secret that SUSupport is continuously developing and expanding the Bulk.Stream®. This is why plate-based freezing and defrosting facilities for stability studies as well as for small to big batch sizes have been developed.

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.

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 industry.

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

Conclusion:
The freezing curves and kinetics are very similar and independent of the RoSS® shells loading (min. or full load) as long the individual RoSS® shells are identical in their setup (bag size and filling volume).
That’s one of the advantages and differentiators of the RoSS® shell that is achieved thanks to the design and combination of polyethylene sidewalls and stainless steel on top and bottom.

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

RoSS.pFTU Flex
Show details

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.