Osmolality, A Critical Quality Attribute For Cell Line Development And Cell Therapy

Osmolality, the measurement of dissolved solutes in media, is a well-established critical quality and process control measure within bioproduction of therapeutic antibodies and in cell therapy. Where osmolality is too high, or too low, production yields and cell viability can be affected, or even an entire batch can be lost. Frequent measurement of osmolality is therefore a crucial component to effect process design. In this presentation, the use of osmolality in bio-production and in earlier process development will be discussed. The case will be made for more frequent, earlier monitoring in cell line development and cell therapy.