SCHOTT Pharma, Gerresheimer, and Stevanato Form Alliance, Push RTU Solutions For Pharma Efficiency
SCHOTT Pharma, Gerresheimer, and Stevanato Form Alliance, Push RTU Solutions For Pharma Efficiency
SCHOTT Pharma AG & Co. KGaA (MDAX: 1SXP), a pioneer in pharma drug containment solutions and delivery systems, together with Gerresheimer AG (MDAX: GXI) and Stevanato Group S.p.A. (NYSE:STVN), 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 risk and lower total cost of ownership
Traditional fill-and-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 also 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.
Schott Pharma AG & Co.藥品封閉解決方案和輸送系統的先驅KGaA（MDAX：1SXP）與格雷斯海默股份公司（MDAX：GXI）和斯蒂瓦那託集團有限公司（紐約證券交易所代碼：STVN）今天宣佈，他們已加入戰略行業聯盟（「RTU聯盟」），以支持即用型（RTU）小瓶和藥筒的市場採用。
RTU聯盟旨在與製藥公司、首席營銷官和CDMO分享高質量無菌初級包裝，特別是即裝瓶和藥筒方面的專業知識和技術知識，重點介紹RTU配置相對於傳統散裝包裝的優勢。
降低風險和降低總擁有成本
傳統的灌裝和精加工過程存在多種運營風險，需要提高效率。通過採用工業即用型（RTU）設置，製藥公司和合同製造組織（CMO）可以從降低運營風險、增強靈活性和效率以及減少浪費中受益。RTU 技術可以幫助簡化流程、提高生產率，從而降低總擁有成本 (TCO)，同時降低污染風險並簡化歐盟 GMP 附錄 1 的合規性。
選擇即用容器的製藥公司、首席營銷官和CDMO也可以從更高質量的產品中受益，這有助於最大限度地減少玻璃顆粒的釋放以及破損或排斥的風險，同時將藥物在整個生命週期中保持在內部。
適用於 RTU 行業標準的開放專家平台
此外，由於對注射藥物的需求不斷增加以及滿足安全標準的監管壓力，市場正在推動對先進無菌灌裝技術的投資。在這種情況下，RTU聯盟旨在創建一個向其他行業參與者開放的專家平台，以幫助行業製造商了解RTU工藝和產品的主要優勢，更好地評估向高效灌裝系統過渡以及滿足其從臨床應用到廣泛商業用途的獨特需求的投資。