West Pharmaceutical Services is a leading provider of innovative, high-quality injectable solutions and services and a trusted partner to established and emerging drug developers.
West has more than 10,000 team members across 50 sites worldwide, and supports customers by delivering approximately 47 billion components and devices each year.
“This year is our 100 year anniversary, a milestone we are very proud of.” says David Maier, Vice President & General Manager, Global Generics Market Unit at West. “Every product has a patient’s name on it.”
“Our customers know that moving from concept to commercialisation is a long journey. Having a partner who understands their needs can not only help customers reach the destination faster, but also help to inspire innovation along the way.”
West’s products range from stoppers and seals for injectable packaging systems, to self-injection and transfer devices. The company plays a key role in supporting vaccine manufactures through supplying high performing containment systems, scalable packaging, and regulatory support.
Speaking to the PharmaSource podcast ahead of CPHI Barcelona, David explains that during the COVID-19 pandemic, West components were used in the majority of vaccines on the market.
“We supported the delivery of over 8 billion doses of vaccine. This required significant efforts to ramp up production and to shift priorities in order to put enough capacity online.”
Sustainability through partnerships
“Collaboration between vendors and customers is critical if the pharma industry is to address emissions, energy usage, water usage and waste reduction.” says David.
“West takes a concerted, cooperative approach with our customers and other stakeholders to work together to achieve ESG targets. This includes investigating shared power purchase agreements, researching more sustainable materials, exploring more efficient shipping methods, and studying beneficial reuses of our products.”
West have announced a new sustainable technology as part of their long-term collaboration with Corning.
West is the exclusive distributor of Corning Viridian™ Vial Technology, a drop-in solution that can reduce vial manufacturing CO2e emissions and material waste while enabling faster and safer fill-finish operations.
“Viridian Vials reduce pharmaceutical glass waste-to-landfill by 20% and vial lifecycle CO2e emissions by approximately 30% compared to standard vials.”1
David Maier
The vials have been shortlisted in the Sustainability category for this year’s CPHI Pharma Awards.
In addition, West are finalists for their FluroTec® 5-10mL Cartridge Plunger, NovaPure® Stoppers & Flip-Off® CCS Seal technology for large volume injections.
Key trend for 2024: GMP Annex 1 in Europe
David highlights that a major trend to be aware of is that regulators around the world are demanding increasing levels of quality, including changes to the GMP Annex 1 in Europe.
“The European Union is not the only territory where the bar of expectation is being raised when it comes to regulatory standards for particulates. The pharmacopeia of the United States, Japan and China also place emphasis on the eradication of visible foreign matter, and updates to risk management and compliance guidance in recent years point to an underlying ambition among regulators to manifest a
future essentially free from particles.”
A deliberate and well-documented contamination control strategy is one of the new focuses in the EU GMP Annex 1 revision. West is well-positioned to help partners prepare for these regulatory changes, says David.
“The evolving regulatory landscape requires pharma and biotech companies to partner with a true expert who can help them navigate the new regulations successfully. Our customers are leveraging our capabilities to support their contamination control strategy. ”
Key trend for 2024: Home-Based Healthcare Market Expansion
Another major trend is the way the home-based healthcare market is expanding, driven by patient demand for more convenient treatment options.
David explains that West’s on-body delivery system SmartDose® was the first large-volume wearable to be approved as a combination product by the U.S. FDA and has since evolved with multiple generations and different sizes.
“SmartDose® is designed to reduce the need for frequent visits to infusion centres. The technology has been approved as a combination product with a marketed drug for use in four different therapies in the market.“2
Footnotes
1. 20% less glass and 30% less emission is based on 30% reduction in wall thickness. Results based on 3rd party Life Cycle Assessment of Corning Pharmaceutical Technologies conducted by Sphera Solutions Inc.
2. West’s SmartDose® on-body delivery system is not independently cleared or approved by any Regulatory Body for general healthcare professional or patient use, nor is it available for general commercial purchase. Its distribution and use are subject to applicable regulatory requirements for clinical investigation, and for marketing authorization, as used in combination with a specific drug or biological product. Each component of a combination product is subject to the requirements established by the Regulatory Body for that component (drug, biologic or device). The regulatory process can be more complicated for combination products including an evaluation of the product characteristics, delivery system and its functionality, intended users and use environment(s), as well as the potential for undesirable interactions between the drug or biologic and the delivery system. As a result, we note that the SmartDose® on-body delivery system’s compatibility with any particular drug or biologic must be confirmed, and its ability to achieve the desired patient benefits must also be confirmed, on a case-by-case basis in a manner sufficient to meet Regulatory Body requirements. Failure to follow product instructions for use may result in compromised sterility; contamination; leakage (including possible exposure to medication); and/or underdosing. Product misuse could potentially lead to needlestick injury, user and/or patient exposure to pathogens or infection, and/or suboptimal or delayed therapy. Products are shown for INFORMATION purposes only. Important product and safety information and warnings available at: https://www.westpharma.com/products/self-injection-platforms/smartdose.
FluroTec, NovaPure, and Flip-Off are registered trademarks of West Pharmaceutical Services, Inc. SmartDose is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Corning and Viridian are trademarks of Corning Incorporated.
West Pharmaceutical Services, Inc. is the exclusive distributor of Corning Viridian Vials.
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