State of the art in drug substance logistics.
And its outstanding advantages for biopharma logistics
The RoSS® basis constitutes an industry standard for single use bags.
Thus, RoSS® stands for 100% compatibility – no system change required.
Flexibility – the RoSS® shell is available for all established single use bag manufacturers and filling quantities.
Safety – thanks to the use of clever materials the single use bag has a 100% protective shell.
RoSS® offers minimal storage volume and maximum strength.
Scalability – RoSS® is the basis for the highly effective BULK.STREAM®
Recycling – even though it is designed for single use, RoSS® can be separated into its components quickly and easily.
RoSS® stands for a safety upgrade for the biopharma process chain.
And its outstanding warehousing efficiency when combined with RoSS.SHIP
SUSupport (Single Use Support) was founded in 2015 by Johannes Kirchmair and Thomas Wurm. It was and is their aim to improve the logistics process for liquids in the biopharma industry on the basis of “Single Use Bags”. All too often the two founders of Single Use Support were confronted with great losses of highest-quality biopharma liquids caused by leakages or bio contamination.
The reason are tiniest material deficiencies of Single Use Bags that are not tested, as well as faulty packaging, and mostly frozen bags that are scarcely protected from external mechanical influences. Furthermore, substantial variations in temperature in the cold chain pose a logistical problem that regularly causes the loss of highest-quality biopharma intermediates or end products.
SUSupport’s first solution is “RoSS®” – a specifically developed shell system that nestles the relatively sensitive “Single Use Bag” – primarily in case of frozen applications. SUSupport offer their RoSS® system for all established manufacturers and filling quantities, like Sartorius or Thermofischer single use bags. Instead of cardboard or polystyrene they use a composite of high quality foam and stainless steel. But RoSS®, with all its obvious protective advantages, was only the beginning.
When sealed, the fairly sensitive single use bag turns into a highly stable shell system, which facilitates the storage of liquids in the tightest of spaces.The individual RoSS® containers can be placed in the RoSS.Ship developed by SUSupport in a compact way. The stable RoSS® Shell units are stored in the stainless steel container construction RoSS.SHIP consuming the equivalent space/volume of standard shipping goods (footprint of a Euro palette). Compact and safe, the liquids contained in the single use bags and stored in the RoSS.SHIP containers can be consistently cooled in the isolated RoSS.Ship container, both actively and passively. For single use end-to-end processes, the RoSS.SHIP container is also available in different materials.
The issue of undetected material deficiencies was not yet solved. SUSupport took the challenge to present the biopharma industry with solutions for preventing risks. With their MITS.2D, SUSupport have developed a mobile integrity test system that enables the testing of a single use bag with a capacity of up to 50 liters in less than a minute in order to guarantee its 100% functionality and tightness. Thus, the MITS is the first integrity test that can be used on the spot in order to assure the intactness of the “single use bag”.
For SUSupport, the missing link in the process thus far was the systematic filling of the single use bags, which in practice is a manual and comprehensive process. This has changed with the development of RoSS.FILL. The Rack (tailored to the single use bags in use as well as the respective RoSS Shell) is fitted with the RoSS® units that are attached to the filling hoses. Up to 20 RoSS® Shells can be filled with an accuracy of +-10Ml g. Fully automated, 200 liters are aliquot in less than an hour and with a safety degree of 100%.
The entire process, which has been reconsidered and newly developed by SUSupport, was named “BULK.STREAM®” by the company’s founders – it stands for “moving liquids in bulk”, like bulk drug substances (BDS), all the way from the downstream to the fill & finish process.
“It is our aim to increase the patient safety and to fashion core processes more intelligently than in the past”, as Single Use Support founders Kirchmair and Wurm state. “Considering the value of the substances, not only for the pharma industry but also for the patients, the established logistics process solutions for biopharma liquids are absolutely underdeveloped.”
In 2018 the team has grown to about 15 people and is constantly expanding. New developments are about to be launched and the production is being expanded due to the growing number of new customers.
Within three years, the two founders have built a company that is being noticed in the international pharma industry.