INSIGHTS ON LIQUID DOSE MANUFACTURING

LIQUID DOSE MANUFACTURING SOLUTIONS

  • Shelf life stability is one of the key challenges for sensitive drug formulations, which have witnessed continuous growth in the past few years and are projected to grow even further in the future.

  • Open RABS as a housing for aseptic processes, e.g., filling, loading, and unloading of freeze dryers. Product protection is achieved by a barrier (oRABS housing with gloves) between the operator and the product.

  • Dec’s ability to provide end-to-end solutions from API manufacturing to primary packaging filling covers the complete range from R&D processes and small batches to large filling campaigns. Our solutions include state of the art robotics for the filling and handling of complex delivery systems like pre-filled syringes (PFS).

  • 2021 Vanrx (Cytiva) SA25 Aseptic Filling Workcell. The SA25 is a gloveless robotic isolator for aseptic fill/finish of nested vials, syringes, and cartridges. Fills 0.2–50 mL with format changeover in approximately 45 minutes. No glove ports; all filling and stoppering occurs robotically inside the isolator. GMP ready July 2022, GMP inactivation May 16, 2025. Last production 2023, four batches total. Serial# PSV00051. Built in British Columbia, Canada. Currently located in Songdo, Incheon, South Korea.

  • AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell® and GENiSYS® systems. AST has experience dosing products at temperatures as low as 3°C.