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NovaPure® components have quality built in from the start. West has developed a comprehensive quality target product profile (QTPP) based on the needs of our customers and end users. Critical quality attributes (CQAs), determined with the end user in mind, have been established to help ensure quality, safety and efficacy throughout a drug product’s lifecycle.
NovaPure® components have quality built in from the start. West has developed a comprehensive quality target product profile (QTPP) based on the needs of our customers and end users. Critical quality attributes (CQAs), determined with the end user in mind, have been established to help ensure quality, safety and efficacy throughout a drug product’s lifecycle.
NovaPure components are available in vial stopper and plunger configurations designed or selected for optimal functionality. All NovaPure components incorporate West's premium quality enhancements: Westar® RS wash or Westar RU sterilization, FluroTec® barrier film, and full West Envision™ automated vision inspection. NovaPure components also come with a comprehensive information and data package.
NovaPure components adhere to QbD principles in design and processing, and represent West's highest standards in components. NovaPure components provide the assurance that components have the tightest specifications applicable within today's formulation and manufacturing process capabilities at West. The NovaPure component QbD approach aims to deliver best-in-class components to support your manufacturing operations, helping to mitigate the risks and maximize the efficiencies of fill-finish processing.
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