Cost Modeling Comparison Of 2D Flatware And iCELLis™ Bioreactors To Produce Adherent Cell Products

By Emmanuelle Cameau and Andrew Laskowski

Despite notable advances in the development of suspension cell lines and transfection techniques, scaling-out static 2D multitray stacks (MT) remains the predominant method for producing viral vector and viral vaccine batches for clinical trials. However, using MTs for commercial material production under good manufacturing practice (GMP) conditions can incur substantial manufacturing costs and introduce significant risks to the process. To address this issue, the utilization of cost modeling tools during process development becomes imperative to ensure the economic viability of the manufacturing processes intended for commercial production.

In this study, BioSolve software, a reference for cost analyses in the biopharmaceutical industry, is employed to compare the upstream (USP) manufacturing cost differences between MTs and the iCELLis™ bioreactor. The iCELLis bioreactor is a fixed-bed bioreactor designed to manufacture adherent cell products, including viral vectors and live virus vaccines. This analysis was conducted at both clinical scale (200 L) and manufacturing scales (800–1000 L) to provide a realistic assessment of the cost of goods (CoGs).