Stevanato and Gerresheimer have teamed up to accelerate the transition from bulk to ready-to-use vials, partnering on the creation of a solution they claim will support significant gains in quality and efficiency.
The collaborators have jointly developed a ready-to-use platform, initially focused on vials, that is based on Stevanato’s pre-sterilized EZ-fill technology. Stevanato and Gerresheimer have sought to develop a platform that integrates into standard fill-and-finish lines to gain efficiencies, improve quality, increase speed to market, reduce total cost of ownership and help mitigate supply chain risk.
Mauro Stocchi, chief business officer at Stevanato, set out the hopes for the platform in a statement to disclose the collaboration with Gerresheimer.
“Our EZ-fill vial platform is the market’s most established choice for pre-sterilized containers, and this enhanced version for RTU vials will bring to the market its full potential in terms of quality, flexibility and values,” Stocchi said. “Through our collaboration with Gerresheimer AG we are responding to market demand, and we expect to achieve another important milestone in creating a reliable ecosystem to support, accelerate and de-risk the conversion from bulk to EZ-fill vials already underway in the market.”
Stevanato and Gerresheimer will make the technology available to other players to standardize fill-finish operations from early-phase drug development to commercialization. The platform will share the same secondary packaging, production process and sterilization method to ensure consistent available capacity and reliable double sourcing.
Lukas Burkhardt, Ph.D., member of the management board of Gerresheimer, highlighted the reduction in particles achieved by the platform as an advantage. The reduction is tipped to improve overall quality.