Development and Scale-up of a Monoclonal Antibody Purification Process

Time to market is essential for producers of monoclonal antibody therapeutics. When working on process optimization for productivity as well as process economy view points, following a LEAN concept is highly advantageous. Introduction of high throughput formats could significantly reduce the time needed for process development as well as facilitating the development of an optimized production process. Another time-saving approach is to use pre-packed and pre-sanitized equipment, including bioreactors, columns and filters during scale-up.

This presentation describes the development and scale-up of a monoclonal antibody purification process. The initial screening of chromatographic resins and operating conditions are performed in 96-well filter plates. The conditions are verified and further optimized in small columns format. Finally, the purification process is transferred to columns suitable for clinical Phase I/II production.