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NovaPure® 组件从设计伊始就重视质量。 西氏根据客户和终端用户的需求制定了全面的产品质量目标特征(QTPP)。在确定关键质量属性(CQAs) 时,牢记最终用户需求,以帮助确保药品在全生命周期中的质量、安全性和有效性。
NovaPure® 组件从设计伊始就重视质量。 西氏根据客户和终端用户的需求制定了全面的产品质量目标特征(QTPP)。在确定关键质量属性(CQAs) 时,牢记最终用户需求,以帮助确保药品在全生命周期中的质量、安全性和有效性。
对于西林瓶胶塞与活塞,可使用NovaPure组件获得最佳的功能。所有NovaPur 组件均采用西氏的高品质升级技术:WestarRS 清洗或Westar RU灭菌,FluroTec阻隔膜和全视觉确认。NovaPure组件还附有完整信息与数据包。
NovaPure组件在设计和加工方面坚持QbD 原则,并代表西氏组件的最高标准。 NovaPure保证,这些组件体现了当前西氏在配方与生产过程中所能实现的最高质量标准。NovaPure的QbD理念旨在提供一流的组件,以支持您的药品生产,有助于减小风险并最大限度地提高灌装-包装工艺的效率。
Globally, the market for biologic drugs is growing significantly, due to their proven ability to treat major chronic diseases, in particular those found among an increasingly aging population. Cartridge systems are very important in delivering these biologic drugs; they can be used in autoinjectors, pen injectors, and wearable devices. Since biologics drugs are very sensitive, they require highest-quality cartridge components.
Prabhaharan Sankaran
Technical Account Specialist, India
Biosimilar development and approvals have been accelerated over the last several years. The rapid uptake in this category is due in large part to clarity on regulatory pathways that demonstrate interchangeability with the reference product and key patent expiry over the next decade. By 2025 injectable biosimilars are projected to comprise almost 50% of the accessible biologics market1. West recently conducted a survey of biosimilar companies to better understand their top needs for packaging and support services during drug development.
Abbey Hisler
Director, Strategic Marketing, Biologics
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
Nancy Liu
Sr. Specialist, TCS, China
Globally, the market for biologic drugs is growing significantly, due to their proven ability to treat major chronic diseases, in particular those found among an increasingly aging population. Cartridge systems are very important in delivering these biologic drugs; they can be used in autoinjectors, pen injectors, and wearable devices. Since biologics drugs are very sensitive, they require highest-quality cartridge components.
Prabhaharan Sankaran
Technical Account Specialist, India
Biosimilar development and approvals have been accelerated over the last several years. The rapid uptake in this category is due in large part to clarity on regulatory pathways that demonstrate interchangeability with the reference product and key patent expiry over the next decade. By 2025 injectable biosimilars are projected to comprise almost 50% of the accessible biologics market1. West recently conducted a survey of biosimilar companies to better understand their top needs for packaging and support services during drug development.
Abbey Hisler
Director, Strategic Marketing, Biologics
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
Nancy Liu
Sr. Specialist, TCS, China