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The landscape of healthcare is continuously evolving, driven by innovations in biologics that offer diverse treatment options and better patient outcomes. With an ever-expanding pipeline and increasing competition, it's important to strategize the lifecycle of your drug product effectively, especially concerning its packaging.
The demand for prefilled syringes is growing, surpassing vials in both growth and market share. Patients favor the ease of use and convenience offered by prefilled syringes and autoinjectors, prompting a transition from hospital-administered to home-administered treatments. This shift not only aligns with patient preferences but also presents cost-saving opportunities for drug companies due to lower manufacturing and product costs associated with prefilled syringes.
Understanding and complying with the complex regulatory requirements is a common challenge drug developers face when bringing molecule to market. Understanding the nuances between packaging in vials and combination products makes your navigation even more complex. Regulatory changes such as updates to EU GMP Annex 1 and the EU Medical Device introduce new changes which can impact your manufacturing processes, compliance standards, and submission filings to regulatory bodies.
Switching from vials to prefilled syringes is becoming more common
You can simplify your transition from a vial to a prefilled syringe by taking a strategic approach to proactively planning your drug packaging selection for your drug product in all potential packaging formats and leveraging the expertise from suppliers to help you navigate regulatory complexities.
Selection of Container Closure Materials
Early planning for container closure materials can streamline packaging development and facilitate a smooth transition from vial to prefilled syringe. By selecting components with the same material composition, such as West NovaPure® products, you can reduce testing, ensure consistent quality, and mitigate supply risks. These components offer the highest quality standards from West, supporting both vial and prefilled syringe drug packaging needs.
Collaborative Approach with Packaging Suppliers
Engaging with packaging suppliers early in the drug development process fosters collaborative relationships and facilitates informed decision-making. With a deep understanding of combination product regulations and regulatory changes such as Annex 1 and MDR, suppliers like West can provide tailored solutions to navigate complex regulatory landscapes. By leveraging supplier support and resources, you can confidently address regulatory challenges and minimize risks to your product launches or launches in a new packaging format.
Streamlining the Transition
Limiting the number of primary materials in contact with your drug product over its lifecycle offers long-term benefits, including easier transitions to combination products and reduced regulatory hurdles. NovaPure® components are designed to support high-quality, performance-driven packaging solutions, facilitating your transition from vial to prefilled syringe formats. With comprehensive support and expertise from packaging suppliers, navigating regulatory complexities becomes more manageable, ensuring successful transitions and product launches.
As you look to develop a new drug product in a vial or prefilled syringe format, West can help you identify container closure solutions that will work with your packaging needs. Learn more solutions and support West can provide you for lifecycle strategies and transitioning from a vial to a syringe in this whitepaper “Simplify Your Move from a Vial to a Prefilled Syringe. Lifecycle Planning for Containment and Delivery of Biologics Drug Products.”
You can find more information about the NovaPure brand at the following web pages for stoppers , plungers, and cartridge plungers. To explore the services and support West offers for drug launch and lifecycle strategies, please Contact Us and we will connect you with a regional account manager.
Many of the top-selling biologic drug products will soon come off-patent. As a result, according to IMS, the biosimilar market is expected to reach between US$1.9-2.6 billion by 2015.
With more injectable biologics coming onto the market, and an increase in combination products, regulatory scrutiny is being given to the interaction between a drug product and its container closure system. If the right container closure and device are not selected for a biologic that is marketed in a prefilled syringe or auto-injector, there could be a significant impact on quality.
In <a href="/blog/2017/june/packaging-supplier-regulatory-support-part-2">Part 2</a> of this series, we discussed the importance of choosing a packaging component supplier with a global focus. In this post, we’ll address the need for a supplier to understand and align with your drivers.
It can take more than 12 years and a major financial investment to bring a drug product to market.<sup>1</sup> A drug product’s success relies on its efficacy, safety and manufacturing efficiencies along with the use of innovative strategies to meet evolving market needs and reinforcement of patient adherence. The importance of container closure and delivery systems as critical to success in the pharmaceutical industry is becoming more visible especially in respect to pharmaceutical and biotech organizations that desire to proactively minimize their risks.
<p style="margin: 0in 0in 10pt;"><span>In <a href="/blog/2017/may/part-1-packaging-supplier-reg-sup-for-med-products">Part 1</a> of this series, we discussed the primary questions to consider when evaluating potential regulatory support from a packaging component supplier. Beginning with this post, we’ll start to look into each of these questions in more detail.</span></p>
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