By Christopher J. Woolstenhulme, Nathan D. Israelsen, Damien Bellos, Alexandre Pereiras Magariños, and Andra Kunzler
Chemically defined cell culture media have been widely adopted in biomanufacturing processes to produce biotherapeutics such as biosimilars, vaccines, and monoclonal antibodies. Performance of these biotherapeutics can be greatly affected by trace impurities introduced by the media raw materials. The additive effect of trace impurities can dramatically increase concentrations of components, including metal salts and other trace impurities. Therefore, precise control of trace impurities is crucial for drug consistency and performance.
Here, a novel approach for manufacturing chemically defined media with precision control of trace impurities is presented. This approach utilizes a combination of innovative raw material analysis, data analytics, and a proprietary algorithm to select raw material lots to manufacture media containing metal and other trace impurity concentrations within customer-defined limits.