AMBR™ 48 AS A TOOL FOR PROCESS DEVELOPMENT AND CHARACTERIZATION FOR THE MANUFACTURE OF A BIOSIMILAR IN CHO CELLS

Recently greater emphasis has been placed on using quality by design (QbD) principles in the development of processes for biopharmaceutical manufacturing. This is not only important for developing processes for novel molecules entering the clinic but also, and perhaps more so, for developing processes for biosimilar manufacturing. In the current work we demonstrate the use of QbD principles to guide the upstream process development of a biosimilar monoclonal antibody producing CHO cell line. In addition of the importance for the molecule to meet the quality attributes of the innovator, so too is it important that a commercially viable process is developed in an timely manner such that the timing of product launch will match as closely with the expiration of patent exclusivity as possible. To accomplish both of these goals we have chosen the ambr™ 48 system for high throughput process development using DOE methodology. Here we show the effectiveness of the ambr™ 48 as a scale down model for process development and compare the results of the key quality attributes to those at the 5L scale. Through this rapid development we were able to define key process parameters that were necessary to achieve a comparable glycoprofile to the innovator as well as parameters that impacted charge variants that bring us closer to those of the innovator.