ADVANCED FLUID & COLD CHAIN MANAGEMENT FOR SMALL VOLUMES

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.

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.

RoSS.PADL is a scalable massaging platform for achieving a uniform mixture in
single-use bags. With integrated cooling and heating, it maintains optimal temperatures
consistently.

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.

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. 

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.

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

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!

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.

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!

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.

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.