Pellicon® Capsules Versus Hollow Fibers For Ultrafiltration/Diafiltration (UF/DF) In Viral Gene Therapy And Vaccine Manufacturing

Tangential flow filtration (TFF) is an essential operation in the manufacturing of complex and life-saving biopharmaceuticals. Technologies used for TFF are hollow fiber modules and flat sheet filters, also known as cassettes. The hollow fiber design was developed by early pioneers in ultrafiltration (UF) technology for industrial applications (e.g., filtration of beverages) and low-pressure pharmaceutical applications (e.g., dialysis). The need to optimize the TFF process to produce therapeutics led to the development of the flat sheet TFF cassette.

Pellicon® cassettes were a result of such developments to provide improved processing speed, linear scalability and high-pressure capability. Traditionally used for multi-use operation, for more than three decades, Pellicon® cassettes have provided robust and reproducible performance in bioprocessing applications. Growing populations, the emergence of new diseases, and recent advancement in novel modalities, such as viral gene therapies, are now driving the implementation of single-use manufacturing technologies to improve speed-to-market of critically needed therapies. The need to reduce process complexity and increase manufacturing flexibility while minimizing product and operational risks spurred the more recent development of Pellicon® Capsules.

Designed for efficient single-use UF/DF, the Pellicon® Capsule is a first-of-its-kind spiral-wound TFF filter engineered to provide linear scalability with comparable performance to our Pellicon® cassettes. Explore methodology and experimental results in the performance evaluation of Pellicon® Capsules versus hollow fibers for UF/DF of viral vectors and describes impact of either filter type on a TFF process.