Qingyu Zeng
Fellow, & Technical Director West Pharmaceutical Services, Inc. Exton, Pennsylvania 19341, USA
Title: Dynamic Challenge of Sealing Performance of Container System for Biologic and Cell & Gene Therapy at Low Temperature
Biography
Biography: Qingyu Zeng
Abstract
For biologic and cell & gene therapy, there has been a challenge in the container sealing performance for cold storage and shipment. Container closure integrity is essential for biologic and cell & gene therapy packaging. The integrity performance must be maintained in real time and over time throughout the entire drug product lifespan. This presentation demonstrates that container sealing performance will dynamically change inherently by itself. Our modeling evaluation and experimental data determined that the time temperature transition critically impacts container sealing performance. The experimental results agree very well with time temperature superposition modeling results, demonstrating that the sealing performance inevitably changes over time together with dynamic temperature transition. The significant loss of sealing performance at lower temperature transitions could potentially contribute significant risk to drug product integrity at low storage and transport temperatures. The present work provides a new, integrated methodology framework and some fresh acumens to the biologic and cell & gene therapy industry for practically and proactively considering, designing, setting up, controlling, and managing container stopper sealing performance throughout the entire sealed drug product lifespan. Particularly, container sealing performance at lower temperature needs to be properly addressed, evaluated, calculated, simulated, predicted, tested, and assessed through an integrated system approach for critical data-driven risk management.