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Cell and gene therapies (CGT) are at the forefront of medical innovation, offering potential cures for previously untreatable diseases. These therapies involve manipulating cellular and genetic material to treat or prevent illnesses. These therapies rely on the handling of fragile, high-value biological materials that must remain free from bioburden and other contamination, potent, and safe at every step—from manufacturing through clinical administration.
West has responded to this challenge by developing the Vial Adapter™ (VA) transfer device and Vented Vial Adapter™ (VVA) transfer device, needle-free transfer devices designed to enable safe reconstitution and transfer while maintaining the integrity of the product through sterile components and aseptic containment. This blog highlights the advancements and implications drawn from technical evaluations of the VA transfer device in CGT application as defined in TR 2019/203 West Vial Adapter™ Performance and TR 2020/224 Evaluation of West’s Vial Adapters for Cell Therapy Applications.
The Vial Adapter™(VA) transfer device enhances safety and product integrity through its needle-free design. By removing the need for traditional needles, the VA transfer device can reduce the risk of needle-stick injuries during drug transfer and preparation—an important consideration in environments handling advanced biologics and gene therapy materials. In cell and gene therapy (CGT) applications, where viral vectors can alter genetic material, preventing accidental exposure is critical to ensuring operator safety. Beyond protecting healthcare workers, the design of the VA transfer device also helps preserve product quality by minimizing the risk of contamination and potential loss of valuable therapeutic material. This dual benefit—protecting both people and product—underlines the VA transfer device’s role in advancing safer, more reliable drug preparation processes.
In CGT manufacturing, ensuring product integrity throughout processing is essential. The West Vial Adapter™ can serve as a crucial component in helping to meet these requirements. The VA transfer device's design facilitates aseptic transfer, preventing accidental microbial contamination that could compromise drug product quality. The vented design of the VVA transfer device removes the need for aspiration by allowing air to enter the vial through a filter. Maintaining aseptic control and containment throughout processing is critical, as CGT products are often produced in small, patient-specific batches with high-cost materials, demanding absolute control over contamination risks.
The interaction between materials used in drug containment and transfer systems and the viral vectors employed in CGT can affect therapeutic outcomes. Maintaining the stability of CGT products poses a significant challenge due to the sensitivity of the viral vectors.
The VA transfer device material of construction is tested to meet ISO 10993 Biocompatibility requirements suitable for the indicated patient populations. In the studies highlighted from Technical Reports 2019/203 and 2020/224, the materials exhibited low adsorption and reduced mechanical stress, minimizing risk of loss or degradation of the active components.
Studies conducted by West1,2 have demonstrated that the VA transfer device remains resilient during exposure to typical cryopreservation media, such as dimethyl sulfoxide (DMSO), crucial for maintaining the integrity of stem cells and viral vectors.
Efficacy is not just about maintaining the intended therapeutic action but also ensuring that the drug's bioactivity is preserved from preparation through final administration steps. Shear stress can alter or damage the structural conformation of biological entities within CGT products, impacting their efficacy.
Shear stress can occur during the transfer phase of preparation and drug delivery and can significantly affect the structural integrity of CGT products. West's Vial Adapter™ transfer device can provide smooth fluid dynamics, minimizing shear stress1. This design consideration is vital for the functionality of viral vectors and cell viability.
Studies conducted by West have demonstrated that the VA transfer device is comparable to small gauge needles for multiple viscosity solutions1. The large gauge spike causes less shear stress during withdrawal versus small gauge needle which may protect against degradation of sensitive large molecule biologics.
With CGT therapies often involving scarce, costly, and concentrated doses, maximizing yield during extraction and transfer is fundamental. The VA transfer devicedesign facilitates the transfer of product allowing for high product recovery rates, ensuring accurate volume measurement and minimizing residual drug.
The personalized nature and complex manufacturing processes of CGT contribute to high costs. Its compatibility with automated and semi-automated filling or transfer systems also helps streamline workflows, supporting scalability from small-batch manufacturing to clinical use. Studies conducted by West have demonstrated that the VA transfer device are capable of volume recovery comparable to that of a needle and syringe1.
Maintaining aseptic conditions, sterile containment, product quality, and operator safety are paramount in the CGT ecosystem. The West Vial Adapter™ and Vented Vial Adapter™ transfer devices offer practical, validated solutions that support these goals throughout the manufacturing and clinical workflows.
Through evaluation and material performance testing, West has demonstrated the devices’ applicability for sensitive therapeutic products that demand precise control over contamination, handling stress, and product recovery. While no single component can address every challenge in CGT delivery, the Vial Adapter™ transfer device platforms represent meaningful progress toward safer, more consistent, and reliable transfer of advanced therapeutic products and stands as a testament to West's commitment to advancing healthcare solutions. As we continue to navigate the complexities of modern therapies, the innovations offered by West ensure that patients receive the most advanced and reliable care.
For additional data and insights, readers are encouraged to access the full technical reports via the West Knowledge Center or contact West’s Technical Customer Support team for guidance on incorporating Vial Adapter™ solutions into CGT workflows.
Vial Adapter™ and Vented Vial Adapter™ transfer devices carry the CE mark (0344) and are 510(k) cleared by the United States Food and Drug Administration. Products are shown for INFORMATION purposes only and may not be approved for marketing in specific regions. Distribution and use are subject to applicable regulatory approvals and requirements for medical devices. The Vial Adapter™ and Vented Vial Adapter™ transfer devices are configurable and may not be suitable for use with all drugs. Refer to drug manufacturer's labeling and use instructions for device configuration compatibility and for shelf life and sterility information of opened or reconstituted drug product. Failure to follow product instructions for use may result in compromised sterility; contamination; leakage (including possible exposure to medication); and/or inadequate medication reconstitution, transfer, and/or dosing. Product misuse could potentially lead to user and/or patient infection, suboptimal therapy, and/or delay in therapy. Please contact your West Pharmaceutical Services, Inc. (West) representative for product availability. Important product and safety information and warnings for Vial Adapter™ and Vented Vial Adapter™ transfer devices available, respectively, at
https://www.westpharma.com/-/media/WestPharma/Files/Products/Vial-Adapter-Indications-Safety-and-Warnings.pdf
and https://www.westpharma.com/-/media/westpharma/files/products/vented-vial-adapter-indication-safety-and-warnings.pdf.
Vial Adapter™ and Vented Vial Adapter™ are trademarks of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
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