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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,” says 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.
About Stevanato Group:
Established in 1949, Stevanato Group is the world’s largest, privately-owned designer and producer of glass primary packaging for the pharmaceutical industry. From its outset, the Group has developed its own glass converting technology to ensure the highest standards of quality. The Group comprises a wide set of capabilities dedicated to serving the biopharmaceutical and diagnostic industries: from glass containers with its historical brand Ompi, to high-precision plastic diagnostic and medical components, to contract manufacturing for drug delivery devices, to vision inspection systems, assembly, and packaging equipment.
The Group also provides analytical and testing services to study container closure integrity and integration into drug delivery devices, streamlining the drug development process. Thanks to its unique approach as a one-stop-shop, Stevanato Group is able to offer an unprecedented set of solutions to biopharma companies for a faster time to market and a reduced total cost of ownership.
About COLANAR:
COLANAR has been introducing innovative solutions to Life Science customers since 2007 and specializes in aseptic fill & finish equipment. With facilities in North America and Europe, the COLANAR Group services a global customer base offering innovative fill and finish equipment of the highest quality. Our flexible equipment ranges from semi-automated laboratory machines to fully integrated isolator lines processing pre-sterilized nested syringes, vials, and cartridges. COLANAR’s additional focus is on extremely high-precision peristaltic pumps and corresponding single-use systems.
