Daikyo Crystal Zenith® (CZ) Ready-to-Use Nested Vials in Tub

Becoming involved during early phases of product development enables the West Contract Manufacturing team to optimize the design, which can yield significant short-term and long-term benefits. These benefits include improved cycle times, lower scrap, lower capital costs and lower long-term maintenance cost...

VIAL ADAPTERTM TRANSFER DEVICES - Options for siliconized spike and in-line particulate filters (available in 5µm, 15µm and 25µm pore sizes) VENTED VIAL ADAPTERTM TRANSFER DEVICES - One piercing spike with two lumens: One for transfer of drug/solution between the drug vial and a syringe and a secon...

TThe SelfDose patient-controlled injector is an off-the-shelf delivery system that is ergonomically designed for optimal patient administration. Extensive human factors studies have been performed with the SelfDose injector, confirming the intuitive design, supporting ease of use a...

Analytical Services

The analytical services team has vast expertise and experience in extractables and leachables, particle analysis, container closure integrity, and performance and packaging/delivery systems among other methodologies. As a result of our understanding of materials and delivery ...

Corning® Viridian® Vials - provide the pharmaceutical industry with an optimized Type I borosilicate vial that reduces glass waste and CO₂e manufacturing emissions, while improving filling line performance. Viridian Vials are a drop-in solution made with 20% less glass material, enabling up to a ...

Get the latest details about West Synchrony™—an integrated, verified PFS system for biologics and vaccines, complete with a single verification data package to help you achieve critical development milestones.

Manufacturers seeking to rapidly change formats in a flexifiller can be challenged by a variety of issues, including availability of nested closures or aluminum particulate from seals. DAIKYO PLASCAP® RUV closures provide one-step assembly through an integrated stopper and plastic cap - helping to e...

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

Daikyo Crystal Zenith® Insert Needle Syringe Systems - The syringe system was designed to maintain purity, integrity and efficacy of premium biopharmaceutical therapies. The system minimizes the potential contamination issues associated with glass and helps to reduce the risk of product interacti...

Ready-to-Use Sterile Packaging

Our portfolio includes superior quality of ready-to-use stoppers, seals, and vials. The West Ready Pack containment solution demonstrates container closure integrity, giving you peace of mind that components work together, speeding up your time to market and reduci...

The SmartDose® 10 On-Body Delivery System (OBDS) consists of a battery-powered, wearable on-body injector with a separate, pre-fillable, polymer based cartridge that is filled with the drug product. The OBDS incorporates human factors and usability testing to deliver a truly patient-centric approach t...

NovaPure® plungers are made from West’s most modern, best-in-class elastomeric formulations with FluroTec™ barrier film to minimize compatibility issues with the drug product. From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitig...

While the drug development team is in the process of working on the last details to optimize the drug, that is where the work for the packaging engineers really starts. A cumbersome journey of scouting and evaluation of all possible packaging options out there, followed by extensive testing and complex interpretation of the results. This process can take many months without assurance of comprehensively addressing all factors. Especially in the space of prefilled syringes which are regulated as combination products, the requirements are expansive and often ambiguous. This presentation introduces a groundbreaking innovation: An advancement in the prefillable syringe market, uniquely integrating the syringe barrel, plunger, and needle shield/tip cap into a fully harmonized, verified system from a single supplier. It will demonstrate how this system enables especially emerging biotechnology companies to significantly save time and resources, accelerating the pathway to clinical fill.

The substantial increase in drug molecules utilizing combination product route to market has led to greater demand for contract manufacturers to support clinical builds (device manufacturing, drug/device assembly, packaging, kitting, and testing) of the combination product. This session will introduce how pharmaceutical/biotech companies can effectively partner with CDMOs to develop a flexible supply strategy to gain access to assembled and packaged drug delivery devices in clinical volumes without having to make substantial capital investment in facilities and equipment, while accelerating their timelines in moving forward with critical steps that are essential for completing clinical trial phases with their drug delivery devices.

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