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製藥股份公司(MDAX:1SXP)，作爲藥品包裝解決方案和遞送系統的先驅，與Gerresheimer股份公司(MDAX:GXI)和Stevanato Group S.p.A.(紐交所:STVN)今天宣佈它們已達成戰略行業聯盟("RTU聯盟")，以支持Ready-to-Use (RTU)小瓶和注射器的市場採用。
RTU聯盟旨在與製藥公司、CMOs和CDMOs分享在高品質無菌一次性初級包裝，特別是準備填充的小瓶和注射器方面的專業知識和技術，突出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
傳統的填充-完成流程存在幾個操作風險，並需要提高效率。通過採用工業化的準備就緒（RTU）設置，製藥公司和 Contract Manufacturing Organizations (CMOs)可以從減少操作風險、增強靈活性和效率、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EU GMP附件1的合規性。
選擇準備就緒容器的製藥公司、CMOs和CDMOs還可以從更高品質的產品中受益，這有助於最小化玻璃顆粒的釋放和破損或拒絕的風險，同時在整個生命週期內保持藥物內部的完整性。
爲RTU行業標準打開專家平台
此外，由於對可注射藥物的需求增加和滿足安全標準的監管壓力不斷增加，市場正在推動對先進無菌灌裝技術的投資。在這種背景下，RTU聯盟旨在創建一個專家平台，開放給其他行業參與者，幫助行業製造商了解RTU流程和產品的關鍵優勢，並更好評估過渡到高效灌裝系統的投資，滿足從臨床應用到廣泛商業使用的獨特需求。
譯文內容由第三人軟體翻譯。