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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。
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.
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.
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.
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.
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.
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.
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