Upstream

Cell life
development
Cell cultureCell cultureHarvest

Downstream

PurificationFormulation

FillFreezeThawShip

Fill & Finish

Seed Stream

NEXT Generation Cell Culture Intensification: Taking the shortcut in biopharma upstream manufacturing process!

SEED.STREAM by Single Use Support describes the next generation of cell culture intensification – the process of how to intensify the inoculation and seed train in the so-called Upstream of biopharmaceutical manufacturers at any scale by means of technologies by Single Use Support. This process includes end-to-end qualification during filling, freezing, thawing and draining of drug substance. At the very early stage of biopharma drug substance manufacturing, the cell banking during upstream, cells are being nurtured from 1 ml to more than 2000 liters within approx. 5 weeks. There are many potential pitfalls in terms of sterility and appropriate cell perfusion when it comes to growing cell lines to their full potential.
Seed train intensification is a way to circumvent the continuous “back to start” with 1 ml and to benefit from the already expanded cells into bioreactors.

And this is where the SEED.STREAM, the next generation of seed train intensification, comes into play.

The very fragile cells need advanced automation, process control and high cell density cryopreservation in order to secure sterility by process in a closed system, avoid manual handling, reduce environmental requirements at the manufacturing site, accelerate the speed of production, simplify the operation in-plant and save huge operation costs during repetitive upstream

If you want to be on the safe side when growing a beautiful flower, you’d also rather plant seedlings instead of casting seeds.

Protect

Fill

Freeze

Thaw

Accessories

Protect

RoSS.KSET

With either RoSS or RoSS.KSET, the sensitive single use bag can be protected as intermediates in Seed Train Intensification. It is covered in 3D foam on the inside and stainless steel on the outside – ideal for controlled freezing process and absolutely robust.

CMO - RoSS.KSET
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RoSS®

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.

RoSS – Single Use Bag Hardshell

Fill

RoSS.FILL CGT

Fully automated filling system for multiple small single use bags at highest accuracy. Applicable for both, cell & gene therapies and Upstream Seed Train Intensification.

RoSS.FILL for CGT fill single use bags for cell gene therapies
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RoSS.FILL advanced

With RoSS.FILL, the RoSS shell systems contained in the rack are filled at a speeed of up to 200 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.

RoSS.FILL advanced

Freeze

RoSS.pFTU lab scale

Controlled freezing and thawing of small batches – more important than ever for seed train intensification. The plate-based freeze & thaw platform for labs RoSS.pFTU Lab scale is the perfect solution for cell culture intensification in intermediates of one or multiple single use bags of up to in total 5l. GMP-compliant computerized system optional.

RoSS.pFTU Lab scale GMP
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RoSS.pFTU Mid Scale

RoSS.pFTU mid scale is a plate-based freeze-thaw unit for studies and small scale batches. Thawing different individual volumes of drug substance up to 100 L with ease. Based on plates, the freezing and thawing time is controlled and rapid.

RoSS.pFTU Mid Scale

RoSS.pFTU Large Scale

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 200l and more.

RoSS.pFTU Large Scale

Thaw

RoSS.pFTU Lab Scale

Controlled freezing and thawing of small batches – more important than ever for seed train intensification. The plate-based freeze & thaw platform for labs RoSS.pFTU Lab scale is the perfect solution for cell culture intensification in intermediates of one or multiple single use bags of up to in total 5l. GMP-compliant computerized system optional.

RoSS.pFTU Lab scale GMP
upscale

RoSS.pFTU Mid Scale

RoSS.pFTU mid scale is a plate-based freeze-thaw unit for studies and small scale batches. Thawing different individual volumes of drug substance up to 100 L with ease. Based on plates, the freezing and thawing time is controlled and rapid.

RoSS.pFTU Mid Scale

Accessories

Ross Trolley

RoSS.RACKs and Trolleys are supporting devices for in-plant transport for up to 26 RoSS® shells. It smoothens the process between various logistics units, such as from filling RoSS® shells to the bulk substance freeze platform (RoSS.pFTU) and helps to store cells during high cell density cryopreservation in upstream seed train intensification.

Store and Ship from Single Use Support