Demonstration Of Scalability For The Corning® Ascent® FBR Platform

Corning has introduced a novel fixed bed reactor (FBR) platform called Ascent technology, specifically engineered to overcome critical hurdles in the cell and gene therapy field. Current methods struggle with efficient scale-up and sufficient production of adherent cells needed to meet the growing clinical demand for these therapies. The Ascent technology tackles these limitations by providing a pathway for seamless scalability from early process development to large-scale manufacturing.

A key innovation of the Ascent technology lies in its uniquely designed fixed bed reactor. This reactor houses a precisely oriented arrangement of polymer mesh disks, which facilitates a uniform, low-shear fluid flow. This controlled environment promotes consistent and even cell growth throughout the entire reactor.

This brief presents data showcasing the scalability of the Ascent technology using a standard viral vector-producing cell line (HEK-293T). First, we demonstrate the platform's scalability by successfully passaging cells across three different reactors, achieving consistent performance at each stage. Cells were initially expanded and harvested from an FBR System 5 reactor and then directly used to seed an FBR System 100 reactor. Subsequently, cells from the FBR System 100 reactor were expanded, harvested, and used to inoculate another FBR System 5 reactor. The ability to efficiently recover viable cells from the Ascent reactors is a significant advantage, enabling their use in seed train and scale-up processes.

Furthermore, we demonstrate the direct transferability of optimized process parameters from the FBR System 5 to the FBR System 100. This capability significantly reduces process transfer times by eliminating the need for extensive re-optimization at the larger scale.