Scaling A Biological Downstream Process For 30,000-L Ultra-large-Scale Biomanufacturing

By Kady Oakley, Ph.D.

Scaling a downstream process from 1 L development to 30,000 L GMP manufacturing means closing gaps in equipment, consumable availability, solution preparation logistics, and process parameter limits. This poster from Kady Oakley, Ph.D., of Boston Institute of Biotechnology, works through scaling decisions for column chromatography, ultrafiltration and diafiltration, and sterile filtration and filling. It sets out which parameters are held constant and which scale linearly, then considers what changes when a column approaches 2 m in diameter or a TFF system faces hold-up volume and pump capacity limits. A microbial protein case study traces the transfer through four scales, with analytical comparisons across them.

Explore the poster to see how the approach was tested and what the data showed.