Vial Adapter Considerations for Cell and Gene Therapy

This technical report discusses the critical considerations for selecting vial adapters (VAs) in cell and gene therapy (CGT) applications. It outlines the importance of maintaining sterility during the transfer of CGT products, which are sensitive to contamination and require precise handling. The report details various factors such as low material-drug interaction, shear stress during fluid transfer, and the need for high product recovery to ensure effective drug delivery. Additionally, it emphasizes the role of VAs in supporting high-throughput workflows and automation compatibility in clinical settings. The report includes a case study on the West Swabable Vial Adapter™ transfer device, demonstrating its effectiveness in extracting lentiviruses with minimal product loss and maintaining viral functionality. The findings indicate that the design of the VA can significantly impact the efficiency and reliability of drug transfer processes in CGT, highlighting the necessity for adherence to regulatory compliance standards for medical devices.