Unveiling the Potential of West Vial Adapter™ Transfer Devices in Cell and Gene Therapy Applications

The field of cell and gene therapies (CGT) is advancing rapidly, with an increasing number of therapies receiving approval for various conditions, ranging from rare genetic disorders to more common diseases like cancer. As the scope of treatable conditions widens, there is a parallel demand for advanced drug delivery systems that ensure these therapies are administered safely and effectively.

In response to this need, West Pharmaceutical Services, Inc. has developed transfer devices, including the Vented Vial Adapter™ and the Swabbable Vial Adapter™, which West has investigated to understand how vial adapter devices can enhance the handling and delivery of CGT products. This blog explores the key considerations and findings from our most recent white paper on Vial Adapter Device Suitability for CGT Applications. 

A New Era of Therapy Delivery

Cell and gene therapies involve the delivery of genetic material to target cells, often utilizing viral vectors or other gene-delivery systems. Due to the biological nature of CGT products, they are particularly sensitive to external conditions during handling and administration.

These therapies are particularly sensitive to handling conditions, making sterility and accurate dose delivery critical aspects of their administration. The West Vented Vial Adapter™ and Swabable Vial Adapter™ transfer devices, needle-free solutions, are engineered to facilitate the transfer of therapies from vials to the administration device , such as a syringe or IV bag, minimizing risk of contamination, maintaining product integrity, and permitting repeatable, consistent dosing.

Key factors for suitability of Vial Adapters in CGT include:

1. Sterility Assurance: Maintaining sterility throughout the cell and gene therapy (CGT) production and administration process is crucial for preserving efficacy and safety. During the manufacturing phase, CGT products are often produced in small batches under stringent conditions, necessary to cater to individual patients, requiring a process that prevents microbial contamination. Strict adherence to regulatory sterilization standards ensures the viability of the batch, safeguarding against potential yield loss and minimizing risk to patient safety. Vial adapters are equally essential in the drug transfer phase, where the final drug product must be extracted with syringes for patient administration. As this phase represents the last step before the therapy reaches the patient, maintaining sterility is critical to prevent contamination. By using vial adapters, the entire process of CGT—from manufacturing to drug administration—maintains high sterilization standards, mitigating the risks of yield loss and promoting a secure and effective drug delivery system.
2. Low Material-Drug Interaction: The materials used in drug containment and transfer devices can significantly influence the effectiveness of CGT by interacting with the sensitive viral vectors involved. West Vented Vial Adapter™ and Swabable Vial Adapter™ devices are constructed using biocompatible materials that minimize adsorption, limiting loss or degradation of delicate viral vectors.
3. Shear Stress Management: Shear stress during the fluid transfer process can significantly impact the biological integrity of CGT products. High shear stress can denature proteins, disrupt cell membranes, and degrade viral vectors, ultimately compromising product functionality and therapeutic outcomes. The design of vial adapter devices has been optimized to minimize shear stress during fluid transfer, preventing any adverse effects on the integrity and functionality of therapeutic products.
4. High Product Recovery: The vial adapter transfer devices are designed to minimize product loss during both manufacturing and administration phases, which is especially important given the small, costly, and highly concentrated doses typical of CGT therapies. In manufacturing, the vial adapter transfer devices allow for regular liquid transfer, crucial for accurate volume measurement and minimizing residual drugs. During administration, it facilitates drug recovery from the vial, maintaining dosing consistency.
5. Operational Efficiency: In manufacturing and clinical settings, vial adapter devices significantly enhance both reliability and scalability by supporting high-throughput workflows and automation compatibility. Their versatility allows for seamless integration with automated systems, accommodating a wide range of vial sizes and reducing operational costs and time.
6. Regulatory Compliance: Vial adapter transfer devices meet stringent safety standards, being classified as Class II medical devices in the U.S. requiring 510(k) approval and CE-marked in the EU. This compliance ensures both manufacturing and administration phases adhere to high safety and performance standards.

Confirming Suitability:

A Case StudyWest conducted a comprehensive study to evaluate the performance of the Swabable Vial Adapter transfer device in extracting lentiviruses, critical vectors in CGT. Utilizing a 2 mL Daikyo Crystal Zenith® vial containment, the study assessed key parameters such as deliverable volume, viral titer, and cell transduction ability.

• Deliverable Volume: This refers to the precise amount of therapy that must be delivered to the patient to achieve the desired biological effect. The West Swabable Vial Adapter transfer device extracted more viral product from the vials compared to other market offerings , showcasing its efficiency and reduced product loss.
• Viral Titer and Functionality : Viral titer quantifies the number of functional viral particles within a given volume. The concentration of viral particles in the formulation directly correlates with the ability to transduce target cells and achieve therapeutic benefits. In our study, both viral titer and functionality were tested. Post-extraction analysis confirmed no significant loss in viral titer or infectivity, affirming the vial adapter device’s capability to preserve the integrity of therapeutic vectors.

Looking Ahead

As the field of cell and gene therapies (CGT) continues to evolve, the West Vented Vial Adapter™ and Swabable Vial Adapter™ transfer devices emerge as a critical enablers of clinical success, maximizing therapeutic yield and enhancing delivery precision. This innovative solution is more than just a leap forward in addressing the unique challenges posed by CGT products; it's a testament to West’s commitment to shaping a future where groundbreaking therapies reach patients more reliably and effectively. By integrating this technology with an unwavering focus on patient outcomes, West is helping ensure that healthcare providers and manufacturers can deliver advanced therapies safely while maintaining the highest standards of patient care.

To explore our full findings and technical details, we invite you to access the comprehensive white paper available through our Knowledge Center or reach out to our Technical Customer Support team for more personalized assistance. As West continues to innovate in drug delivery packaging, we remain committed to empowering our clients with solutions that redefine excellence in healthcare delivery.

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This document is for informational purposes only. West’s products and solutions are sold on the basis that it is the customer’s responsibility to evaluate and test the West product or solution to determine its compatibility with other materials and fitness for any end use.

WEST MAKES NO WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING, WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR PARTICULAR PURPOSE, RELATING TO THE INFORMATION IN THIS DOCUMENT.

Vial Adapter and Swabable Vial Adapter are trademarks of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Crystal Zenith is a registered trademark of Daikyo Seiko, Ltd. and is used under license.