iCELLis500: A Versatile Manufacturing Platform For CGT And Oncolytic Virus Production

By Dr. Martin Pech, Sabrina Pelz, Cihan Sözen, Stefan Augustin, Thomas Rautenberg, Elke Pommerening, Julia Janson, Frank Mahrla, Michael Kijas, Mathias Kahl, IDT Biologika

Successfully navigating the clinical and commercial manufacturing of Cell and Gene Therapy (CGT) and Oncolytic Virus (OV) products requires scalable and flexible production platforms. This requires implementing state-of-the-art technologies for both Upstream Process (USP) and Downstream Process (DSP), adaptable across various stages of a product's lifecycle.

Two Phase 3 client projects—one involving an Adeno-Associated Virus (AAV) and another an oncolytic Parvovirus—demonstrate the successful implementation of the iCELLis500+ fixed-bed bioreactor platform. The AAV project achieved a successful seed train adaptation and an overall 75% increase in Bulk Drug Substance (BDS) titer. For the OV project, a simplified, scalable, and closed-state USP and DSP process was successfully implemented, supporting a greater than 10x process scale-up while maintaining comparable BDS titer.

Explore the lessons learned and best practices from these successful programs, including how automated DSP equipment like ÄKTA Ready chromatography systems and ÄKTA Readyflux TFF systems streamline clinical and commercial production.