Stevanato Group and Colanar colaborate to study container closure systems
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The data generated through the partnership will help biopharma companies to develop robust manufacturing processes and minimize challenges during scale-up and commercialization.
Italian-based Stevanato Group, a producer of glass primary packaging and provider of integrated capabilities for drug delivery systems, has signed an agreement with Colanar, a manufacturer of small-batch pharma filling machines.
Stevanato Group's new US Technology Excellence Center (TEC) in Boston will be equipped with COLANAR'S fill and finish machine to perform analytical characterization and determine critical factors affecting 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 addresses flexibility, high accuracy, and short changeover requirements - 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 ... will ensure our new US TEC provides robust data for critical fill and finish parameters for clinical batch manufacturing, facilitating scale-up and commercialization," said Abizer Harianawala, Site Leader at Stevanato Group TEC.
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