Stevanato Group's new US Technology Excellence Center (TEC) in Boston will be equipped with COLANAR'S fill & finish machine to perform analytical characterization and determine critical factors impacting container closure systems.
The Modular Filling System FSM by COLANAR is developed for the filling and vacuum stopper placement of ready-to-use nested vials, cartridges, and syringes. This system, built to the highest GMP quality standards, addresses flexibility, high accuracy, and short changeover requirements. These are essential factors when dealing with highly sensitive drugs such as biologics.
The FSM will allow Stevanato Group's US TEC scientists to fill glass containers with buffers, placebos, and drug products and immediately test them. This will provide rapid data about the impact of the filling process on a formulation and container closure system helping biopharma companies to develop robust manufacturing processes and minimize challenges during scale-up and commercialization.
"The FSM machine is a key asset in our laboratory that will provide biopharma customers with an additional service for conducting stability testing on filled products. It will ensure our new US TEC provides robust data for critical fill & finish parameters for clinical batch manufacturing, facilitating scale-up and commercialization," says Abizer Harianawala, Site Leader at Stevanato Group TEC.
The SG US TEC, set to open its doors in Boston on Sep. 24, will provide end-to-end services to support biopharma customers along the entire drug development journey, from the early stage through commercialization of the final drug product. The SG US TEC can support the full life cycle management and therefore reduce the risk and time required to bring products to the market.