Colorimetric and Physico-Chemical Property Relationships of Chemically Defined Media Powders Used in the Production of Biotherapeutics.

Growth of mammalian cells in the production of biotherapeutics often require the benefits of chemically defined media (CDM). Storage, handling and stability advantages of CDM powders govern the preponderance of their use across the industry. Physico-chemical property lot-to-lot variation of these multicomponent powders, however, continues to be a challenge. Process imposed degradation of amino acids and vitamins, for example, can influence cell density, specific titer, and the quality profile of the molecule expressed due to the lack of process understanding and suitable mitigation controls. Such degradation can materialize in either their manufacture or in downstream media dissolution steps. Colorimetry, in lieu of visual appearance, can be an effective surveillance method for the direct assessment of CDM quality as color change is indicative of chemical-physical variations. This work describes a series of studies aimed to establish relationships between quantitative color change and physico-chemical attribute variation of glucose-free and glucose-based powders. The results illustrate color change is indicative of amino acid glycation, vitamin degradation and particle size shifts. These relationships enable a colorimetric control strategy for the sensitive and rapid detection of relevant CDM variation to drive additional targeted assessments to improve the productivity and robustness of cell culture processes. [ABSTRACT FROM AUTHOR]