West Pharmaceutical Services, Inc.

The Daikyo® Crystal Zenith® (CZ) 2.25mL insert needle is a break-resistant, polymer syringe of choice to protect larger volume sensitive molecules during self-administration. For drug developers wishing to avoid glass, this syringe system protects delicate molecules as there is no silicone oil added for fu...

Through a strategic partnership with Corning, one of the world’s leaders in glass science, West is redefining the future of containment solutions by creating a truly integrated system that will help de-risk customers’ drug development and manufacturing processes by providing comprehensive product informati...

The SmartDose platform offers a wearable, subcutaneous injector with an integrated drug delivery system that incorporates human factors and usability testing to deliver a truly patient-centric approach to self-administration.

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.

With glass-like transparency, but superior break resistance and low risk of chemical interactions, Daikyo Crystal Zenith® vials can help avoid issues including delamination, and particulates.

The Daikyo Crystal Zenith® Insert Needle and Luer Lock Syringe systems were designed to maintain purity, integrity and efficacy of premium biopharmaceutical therapies.

An ideal choice for single- and multi-dose drugs, West components for prefillable systems help to ensure a more consistent injection rate to help patients receive accurate dosing with their treatment regimen.

The West Contract Manufacturing team is focused on serving the needs of healthcare companies by providing a single-source solution from product conceptualization through manufacturing and final packaging.  

Reconstitution devices enhance drug reconstitution, mixing and transfer through advanced technologies.

The West Ready Pack® system is comprised of high-quality primary and secondary packaging components. The Ready Pack system consists of sterilized NovaPure® stoppers, Flip-Off® seals, vials and vial adapters.

The SelfDose patient-controlled injector is an off-the-shelf delivery system that is ergonomically designed for optimal patient administration.

West offers analytical services for specialized testing and analysis to evaluate the compatibility of drug products with their packaging or administration system for pharmaceutical and biopharma customers.

West and Corning Launch Viridian™ Vials that provide both performance and sustainability to the healthcare industry

There are two major themes that involve primary packaging components in the revised EU GMP Annex 1 issued in August 2023. This recent revision includes: Implementing a holistic Contamination Control Strategy (CCS) Container Closure Integrity (CCI) because a properly seated stopper represents an adequate microbiological barrier. Pharmaceutical manufacturers must develop a CCS detailing the risks and mitigations within their operations, associated with contamination event opportunities with the emphasis being on personnel awareness, quality culture and controls, with focus on the principles involved in the protection of sterile product during the manufacturing, packaging and distribution processes.
This is why it is important to consider packaging decisions early in the development process. We will examine how primary packaging materials can impact your CCS and showcase West’s approach to mitigating risk on behalf of drug developers.

4040/40 elastomer formulation was designed with ‘future in mind’ to meet the ever-increasing performance & quality standards expected of primary drug packaging. The presentation will summarize the extensive Quality by Design (QbD) process that was undertaken to develop this new formulation as well as considerations taken for closure design dedicated for Lyophilization applications. Details of the extensive characterization that was performed as part of product development as well as data to demonstrates the overall performance of the new rubber formulation for lyophilization stoppers with respect to Extractables/Leachables, Particulates, Moisture, Container Closure Integrity (CCI), Particles and Manufacturability will be presented.

Advanced therapies are rapidly becoming a reality, targeting unmet patient needs and treatments for diseases with limited therapeutic options. Some advanced therapies, such as gene therapy and mRNA, require cryopreservation due to their fragile nature at room temperature, putting unprecedented expectations on the packaging systems to maintain Container Closure Integrity (CCI) during storage at -80°C. The quality, patient safety, and high value of these therapeutics can be jeopardized if the chosen containment system doesn’t consistently maintain a sterile barrier from when the drug is packed through to administration to the patient. During cooling between room temperature and -80°C, common vial system components such as glass vials, elastomeric closures, and aluminum seals exhibit contraction and changes in physico-mechanical properties. These changes in material properties and component dimensions may affect the system’s ability to maintain closure integrity, resulting in the formation of transient leaks.
In this joint study conducted by West and Corning, we discuss results from four experiments that explore the influences of capping pressure, cooling rate, dimensional changes, and long-term storage at -80°C on the system’s ability to maintain closure integrity. Both Helium leak testing and laser-based gas headspace analysis were used to monitor the closure integrity. The key result of the study is a combination of vial system components and capping conditions that maintain container closure integrity when cooled to and stored at -80°C

Our healthcare industry is evolving. The move from IV to SC injection is being driven by lifecycle management, biosimilar adoption, and the hospital to home trend. Molecules are getting more complex, and patients drive the preference for self-administration resulting in the need for more complex combination product development and quick scale up. We will present innovative solutions to these challenges to help speed up drug development and enable patient choice with: A 2.25mL polymer container system for auto-injectors which protects sensitive molecules A large volume cartridge plunger to enable primary containment within an on-body delivery system A small pack, high quality glass containment system to enable quick delivery in early-stage development