Liquid Transfer in Biopharma Manufacturing

BULK.STREAM®: Drug substance handling at a higher level

We close the gap between downstream and the fill & finish process in the biopharma industry. On the basis of single-use bags, we offer biopharma companies access to a new and almost 100% secure logistics process for liquids.

The technologies developed by us increase patient safety and minimize the risk of bio contamination and product loss towards 0%. Storage and shipping of high-quality substances, such as APIs (active pharmaceutical ingredients), buffer, media, or other liquids can be performed in a faster and more secure manner than to date. We build upon standards, eliminate material deficiencies, and minimize human errors.

The end-to-end process for liquids at large volumes is called the BULK.STREAM®.

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Upstream

Cell life development Cell culture Cell culture Harvest

Downstream

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Purification Formulation

Fill Freeze Thaw Ship

Fill & Finish

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Bulk Stream

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Protect

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Fill

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Freeze & Thaw

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Store, Ship, Track & Trace

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Thaw

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Drain

Protect

RoSS® Shell

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.

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RoSS.KSET

Single use bags with a volume of less than 250ml are covered with a first layer of soft 3D foam which is complemented by an innovative and intuitive locking mechanism. Its robust stainless steel frame protects the single use bag during freezing and shipping.

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RoSS.LIQU

RoSS.LIQU is a container made out of a rigid and smart stainless steel tote to protect 3D single-use bags with large volumes of up to 1000L for shipping applications. Fully robust. Entirely safe. Available now.

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Fill

RoSS.FILL Bag

With RoSS.FILL, the RoSS shell systems contained in the bag rack can be filled with a speed of up to 300 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.

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RoSS.FILL CGT

Fully automated filling & draining system of multiple small single use bags in cell & gene therapies at highest accuracy.

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RoSS.FILL Bottle

The control unit of RoSS.FILL can easily be attached to a bottle filling rack - maintaining the advantages of accurate, fast and configurable filling of biopharmaceuticals. Multiple racks can be attached for limitless scalability.

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RoSS.FILL Base

Fully automated filling & draining system. Up to 12 single use bags ranging from 50mL to 50L. Filling of 1000L 3D single use bags possible.

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Freeze & Thaw

Freeze Thaw Platform

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.

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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 volumes of drug substance up to 70L with ease. Based on the plates, freezing and thawing time is rapid and controlled.

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RoSS.pFTU Lab Scale

Controlled freezeing and thawing of small batches - more important than ever for cell & gene therapies and clinical studies! The plate-based freeze & thaw platform for labs RoSS.pFTU Lab Scale is the perfect solution for one or multiple single use bags of up to in total 5L. GMP-compliant computerized system optional.

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RoSS.pFTU Large Scale + Autoload

Full automatic loading and unloading kit for RoSS.pFTU large scale

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Store, Ship, Track & Trace

RoSS.SHIP

RoSS.SHIP offers the your tailored solution for 100% protection from external mechanical influences for RoSS shell systems. Different possible sizes will fulfil your individualized need. With passive cooling, it maintains its ultracold temperatures for international shipments over multiple days. With its measurements it complies with international logistcis standards. Also monitoring temperature and tracking its location is no problem.

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Thaw

RoSS.pFTU Mid Scale

The freeze & thaw system RoSS.pFTU is a fully automated and scalable. Both economically and in terms of product stability we have reached the next level. The plate-based platform RoSS.pFTU Mid Scale is completely adapted to RoSS shell system and suitable for thawing batch sizes of up to 70l.

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RoSS.pFTU large scale

RoSS.pFTU Large Scale is fully automated and scalable freeze-thaw platform suitable for thawing up to 200L and more.

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Drain

RoSS.DRAI

RoSS shells are placed into RoSS.DRAI. The automated draining racks get connected to the peristaltic pump to keep holdup volume in bags to the minimum and to provide draining bags of up to 20L. Multiple racks can be attached allowing draining of up to 60 bags/run.

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