Stevanato Group’s US Technology Excellence Center (TEC) in Boston, USA will be equipped with fill and finish capabilities for its pharmaceutical glass packaging, after it signed an agreement with Colanar.
Colanar is a specialist in the supply of small-batch pharma fulling machines.
The agreement means Stevanato can also perform analytical characterisation and determine critical factors impacting container closure systems.
Colanar’s Modular Filling System (FSM) is developed for the filling and vacuum stopper placement of ready to use nested vials, cartridges, and syringes.
This solution 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 minimise challenges during scale-up and commercialisation.
Abizer Harianawala, Site Leader at Stevanato Group TEC, said: "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 and finish parameters for clinical batch manufacturing, facilitating scale-up and commercialisation."
Bernd Stroeter, President at Colanar said: “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."
Stevanato’s technical centre in Boston is due to open its doors on September 24 and will provide end to end key services to support biopharma customers along the entire drug development journey, from the early stage through commercialisation of the final drug product.