Gerresheimer AG (MDAX: GXI), an innovative system and solution provider and a global partner for the pharma, biotech and cosmetic industries, together with Stevanato Group S.p.A. (NYSE: STVN), and SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP), announced today that they have entered into a strategic industry alliance ("Alliance for RTU") to support market adoption of Ready-to-Use (RTU) vials and cartridges.
The Alliance for RTU aims to share with pharmaceutical companies, CMOs and CDMOs expertise and technical knowledge in high-quality sterile primary packaging, specifically ready-to-fill vials and cartridges, highlighting RTU configurations' advantages over conventional bulk packaging.
Reduced risks and lower total cost of ownership
Traditional fill & finish processes present several operational risks and require increased efficiency. By adopting an industrial ready-to-use (RTU) setup, pharmaceutical companies and Contract Manufacturing Organizations (CMOs) can benefit from reduced operational risks, enhanced flexibility and efficiency, and lower waste. RTU technology can help streamline processes, increase productivity, and thus lower total cost of ownership (TCO) while reducing contamination risks and easing EU GMP Annex 1 compliance.
Pharmaceutical companies, CMOs and CDMOs opting for ready-to-use containers can benefit from higher-quality products, which helps minimize the release of glass particles and risks of breakage or rejection while preserving the drug inside throughout its entire life cycle.
Open expert platform for RTU industry standard
Additionally, the market is driving investment in advanced aseptic filling technologies due to increasing demand for injectable medicines and regulatory pressure to meet safety standards. In this context, the Alliance for RTU aims to create an expert platform open to other industry players to help industry manufacturers learn about the key benefits of RTU processes and products and to better evaluate investments for transitioning to efficient filling systems and meeting their unique needs from clinical applications to widespread commercial use.
"As an industry, we are fully prepared for the transition to RTU vials and cartridges,” said Lukas Burkhardt, Member of the Management Board of Gerresheimer AG. “With recent advancements, RTU processing is now a mature technology which will improve our customers operations in terms of efficiency, cost and time to market."
“RTU vials and cartridges represent a significant advancement in product quality, offering enhanced reliability and efficiency in pharmaceutical processes. This alliance allows us to highlight further how RTU solutions elevate standards across the industry, ensuring safer and more effective delivery of medications to patients worldwide" said Franco Stevanato, CEO at Stevanato Group.
“The shift towards ready-to-use vials and cartridges reflects a collective industry move to advance quality and efficiency in aseptic filling processes and this alliance shows readiness by expanding capacity and thereby supporting this market trend,” said Andreas Reisse, CEO at SCHOTT Pharma. “Ready-to-use solutions can reduce complexities and better meet the stringent requirements of modern pharmaceutical production.”
The Alliance for RTU will be officially presented at the CPHI in Milan on October 8, 2024 during a dedicated event at the tradeshow fairground.
For more information, visit www.alliance-for-rtu.com.