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This summer, West Pharmaceutical Services was delighted to exhibit at the 1st PDA Europe Annual Meeting. PDA organized this unique conference about the future of injectables to provide participants with a first-hand opportunity to gain deeper insight into current and future advances in modern sterile manufacturing and quality oversight. West also supported the NovaPure® 1-3 mL plunger launch during the meeting. Throughout the event, attendees were given the opportunity to engage with speakers, industry peers, regulators and exhibitors.
West was actively involved by leading the course, “Development and Manufacturing of Pre-filled Syringes,” which was offered during the training workshops. The course provided an overview about practical aspects and trends of developing and processing pre-sterilized primary packaging systems and also focused on hot topics such as aseptic environments, particulates, silicone and single-use filling. Additionally, participants could learn from parallel tracks focused on areas such as Test Methods for Pre-filled Syringes, Cleaning and Disinfection, How to find the Right GMP for API’s, and Root Cause Investigation.
At the show, West showcased a range of high value products and highlighted the 1-3 mL NovaPure Plunger—an innovative, high-quality component for pre-filled delivery systems, designed to reduce particulate, ensure consistency of delivery and fit the changing needs of higher-volume injectable drug delivery systems. Technical details of the 1-3 mL NovaPure plunger were summarized in a comprehensive poster that was displayed on site.
To learn more about meeting visit their website. More information about the NovaPure brand can be found on the West website.
Modern biopharmaceutical drug molecules are often complex protein structures that need to maintain the molecular structure in order to convey full potency. With biologics, any alteration of the 3-D structure could lead to loss of activity or even to immunogenic reactions in the patient. Proteins can be disrupted by interactions with the container closure or with leachables. West FluroTec® lamination was chosen for NovaPure® plungers to reduce the interaction between the drug product and elastomer material. This includes less adsorption to the plunger surface as well as reduction of the leachables profile of the plunger, helping to maintain the stability of complex molecules.
Mitigate risk of contamination, enable accurate dosing, while maintaining the stability and sterility of parenteral products
As drug development continues to evolve, further advances in delivery technologies will help to refine the overall drug delivery system, from improvements to safety and performance of delivery devices, to primary containers with consistent and higher-quality components.<br />
<strong>NovaPure® Components Overview</strong><br /><em>By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.</em>
The global pen injector and auto-injector markets have witnessed significant growth due to the increasing demand for self-administration of injectable drugs. Pen injectors and auto-injectors provide a user-friendly and convenient solution for patients to administer medications, contributing to improved patient compliance and overall healthcare outcomes. There are well established traditional market segments that use cartridge-based delivery systems, including dental local anesthesia and diabetes care, as well as human growth hormone and allergy therapies. However, there have been significant developments in the incorporation of cartridges in auto-injectors as supposed to the traditional syringe designs.
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