Sourcing limitations and the efforts to minimize introduction of adventitious viral or prion agents in the production of biologics have over the years accelerated the adoption of serum-free cell culture media. The subsequent use of animal component free media containing plant derived hydrolysates in cell culture processes has come with observed variability in cell growth, productivity and product quality of biologics. In its purest and supposedly most consistent form, cell culture media has evolved to chemically defined media. As part of a media vendor qualification study, four proprietary media formulations manufactured by five vendors were tested for composition, particle size distribution and solubility characteristics.  There was a direct correlation between the particle volume mean diameter (VMD), time to solution and final media turbidity. Differences in media turbidities before and after filtration indicated particulate removal during filtration step, suggesting that some components were not going into solution and therefore unavailable to cells in the bioreactor. Differences between expected and measured levels of trace elements suggested that there were other extraneous sources of trace elements, especially manganese. Functional cell culture testing showed that these variations in concentrations of media components had some product quality impact and need to be controlled for consistency in cell culture process performance.

Chemically defined media: Your formulation and what the cells see

247th National Meeting (2014)

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