ADVANCED FLUID & COLD CHAIN MANAGEMENT FOR SMALL VOLUMES

The One Process for Small Volumes in Biopharma

Our single-use technologies and sterile consumables come with the flexibility required for fast turnaround times in advanced therapeutic approches & the handling of small volumes down to 1mL. This includes the areas of aliquotation & filtration, controlled freezing & thawing and all required logistic steps.

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Why is this process the one for you?

The Accurate One

Fill and freeze your products with the highest accuracy. With a filling accuracy of less than +/- 1mL and reproducible freezing recipes for your optimal result.

The Flexible One

Independent from type, manufacturer and size of your single-use bag, the modular platforms and single-use technologies will meet your requirements.

The Secure One

Automated aseptic filling at highest accuracy minimizes both operational human errors and overfilling of single-use bags. Controlled plate-based freezing and thawing of single-use bags prevents loss of product quality due to cryoconcentration and reproducible freezing and thawing.

The Trusted One

With more than 200.000 RoSS shells sold and 180 platform systems commissioned, Single Use Support is a trusted pioneer in Biopharma for optimizing drug substance handling. 

Learn More

SUS_Advancing ATMP Fluid Management

eBook: Advancing ATMP Fluid Management

Filesize: 2.61 MB – Mime-Type: application/pdf

Products

RoSS.KSET top view

ROSS.KSET | Protecting small single-use bags

RoSS.KSET offers the protection for drug substances with volumes less than 250 mL. The shell of our CGT bag protection system is robust, closed, safe and sterile – most suitable for cell and gene therapies or clinical studies.

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IRIS Manifold | Single-Use Assemblies

As an expert in single-use solutions, we have made it our goal to deliver vendor agnostic single-use assemblies manufactured at highest quality standards in ISO 7 cleanrooms and sterilized within shortest lead times. Prevent downtime and ensure an uninterrupted supply chain in compliance with GMP and regulatory requirements with our customized single-use manifold assemblies.

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RoSS.PADL | Homogenizing Solution

RoSS.PADL is a scalable platform for cooling your single-use bag whilst gently massaging it to ensure there is a homogenous mixture of the solution. With the RoSS.PADL multiple cooling and massaging mechanisms can be placed side by side with one control system.

Cell and gene therapy filling machine with RoSS.FILL CGT system

RoSS.FILL CGT | Fill-Filtration | 1mL-1000mL

1mL-1000mL: Fully automated cell and gene filling machine system for aseptic filling of multiple small single use bags. Special designed for use in cell & gene therapies with batch sizes at low volumes. With its high filling accuracy, the platform provides filling from 36 up to 128+ bags with one or several racks.

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RoSS.pFTU Mid-Scale | Plate Freeze & Thaw

Up to 100L: Our mid scale freezer is a plate freezer and thaw unit designed for RoSS shells, to protect your preferred single-use bag during cryogenic applications. 

RoSS.pFTU mid scale is compatible with single-use bioprocess containers of all sizes and manufacturers and shows best product stability results for your biopharmaceuticals up to 100L. 

Cryogenic Freezer RoSS LN2F

RoSS.LN2F | Cryogenic Freezer

RoSS.LN2F is a powerful cryogenic controlled rate freezer for temperatures down to -170°C/-274°F. An enclosed LN2 system and our innovative direct injection system ensure no direct exposure and no mechanical compressors are needed. This ensures a safe, low-maintenance and energy-saving handling.

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RoSS.FRDG | Ultra Cold Storage Freezer

Reliable ultra-cold storage down to -80°C (-112°F) with best-in-class temperature conformity, high storage capacity and modular interior design.

Single Use Support shipper

RoSS.SHIP | Ship, Track & Trace

RoSS.SHIP secures the cold chain shipping and storing of bulk drug substance for almost one week. Highly robust, stackable, coolable and compact – Fort Knox for high-quality substances!

Robust Frozen Storage & Shipping

RoSS Technologies provide process flexibility for smallest volumes with highest accuracy.

  • Closed, robust and tamper-evident protection of your single-use bag for highly valuable drug substances
  • Vendor-agnostic and hence compatible to other systems during senstive freezing applications
  • Process flexibility for safe handling regardless of type and size of bag manufacturer without being trapped in siloed biopharma process solutions 
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Consult one of our experts

More information

Solution Overview_Small Volumes_Single Use Support

Fluid Management Solutions for Small Volumes

Filesize: 2.58 MB – Mime-Type: application/pdf

App Note_Bestcellers-Controlled Filling Freezing of Cells

App Note: "Bestcellers": Controlled Filling & Freezing of Cells

Filesize: 2.4 MB – Mime-Type: application/pdf

Guide_Navigating 5 Overlooked Challenges in Viral Vector Manufacturing_Single Use Support

Navigating 5 Overlooked Challenges in Viral Vector Manufacturing

Filesize: 1.21 MB – Mime-Type: application/pdf

Relevant Articles

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Advancements in Small Volumes Drug Freezing Techniques

Freezing small volumes extends beyond laboratory settings to include commercialized manufacturing processes for small batches in biomanufacturing, like cell banking, gene therapies utilizing viral vectors, lipid nanoparticles, and fill & finish procedures.

Protection of small single-use bags at it's best

Small volumes of ATMPs: Safe handling of single-use bags

Cell and Gene therapies such as CAR T-cell therapy have proven their potential to become standard treatments to hard-to-treat diseases. Single Use Support has developed solutions for crucial challenges - read more!

RoSS.FILL Lab Scale offers unprecedented filling accuracy

Aseptic Filling of Small Volumes with High Precision

Filling accuracy has become increasingly important for laboratories and biopharmaceutical manufacturers. Single Use Support has developed best-in-class filling precision for aliquoting small single-use bags with its RoSS.FILL Lab Scale aseptic filling platform.

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Increasing Patient Safety: Risk assessement in filling process of small volumes

Autologous therapies and other ATMPs with small volumes exhibit certain specific requirements. The scope of handling advanced therapies require special handling and care. When handling of small volumes is already automated in an early stage, it is a way more straightforward path to commercialization of the drug product. The benefit of a closed systems with automated solutions add value by offering a higher degree of sterility, safety, and process flexibility.