Italian-based Stevanato Group, a leading producer of glass primary packaging and provider of integrated capabilities for drug delivery systems has signed an agreement with COLANAR, a global leader in small-batch pharma filling machines.
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 solution, 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 Stevanto 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,” said Abizer Harianawala, Site Leader at Stevanato Group TEC.
Bernd Stroeter, President at COLANAR commented, “We are proud to partner with Stevanato Group at its US TEC complementing its offering with our proven and scalable F&F solution for biologics. The combination of our reliable equipment and the extensive testing methods supplied by Stevanato Group’s US TEC will support biopharma companies selecting the best-suited container and drug handling, de-risking the entire manufacturing process, and improving the time to market.”
The SG US TEC, bound to open its doors in Boston on September 24th, will provide end to end key 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.