Billions of dollars is what the pharma industry loses each year due to product loss based on lacking or insufficient protection of single-use bags used for liquid transfer. Where many process areas in the production of (bio)pharmaceuticals experienced some modernization, the cold chain logistics remain mostly unchanged, with companies still using naked bags or glassware to handle product worth billions of dollars. With up to 5% lost product attributed to shipping, freezing, and thawing of these high value liquids between final polishing and fill and finish it is surprising that little advancement has been made until now.
Single Use Support has created products and technologies to address exactly these key concerns. The robust shell to protect single-use bioprocess containers in the process of freezing, storing, and shipping, RoSS® (Robust Storage and Shipping), is agnostic to manufacturer, design, and volume, allows for the safe handling of frozen and thus fragile single-use bags. Accompanying freeze and thaw as well as fill and drain systems work in synergy with the shell for single-use bags to allow for a safe solution for optimized fluid management.
Safe handling of single-use bioprocess containers with minimized product loss
With over 200,000 shells shipped, less than 0,001% product loss has been reported. Assuming an industry-wide average loss rate of 1.5% without a robust protective shell, would mean that Single Use Support’s device has saved around one thousand five hundred bags in the short time since its conception. Besides the obvious value of product saved, more importantly is the amount of potentially lifesaving drug that has been saved and made available to patients.
Novel technologies such as single-use plastics and process intensification have readily been adopted to other areas of the drug manufacturing process. Now it is up to big pharma to again lead the way in modernizing the way drug substance is shipped and handled. With RoSS®. Instead of product loss.
Key Learning Objectives:
- How protective shells prevent the loss of drug substance when stored and shipped in single-use bags
- How protecting shells help save costs
- Why single-use bag-independence increases process flexibility
- Why RoSS® optimizes process solutions for fluid management
