Cell culture media [which includes basal cell culture media nutrient feed, and supplements (e.g., hydrolysates)] are complex mixtures that are usually comprised of a wide variety of components, including but not limited to salts, amino acids, sugars, vitamins, and minerals. The type and amount of these individual media components are quantitatively formulated to maximize protein expression, yield, and refolding of proteins to the active state.
In addition, these media components also contain trace elements that may impact cell growth, protein expression, glycosylation patterns, and protein quality during upstream manufacturing processes. It is widely acknowledged that even small changes in these trace element concentrations in the media can have a large impact on product quality. Trace element concentration variability has been observed in both lot-to-lot and vendor-to-vendor cell culture media components. As a result, a thorough biologic elemental monitoring program for measuring and defining acceptable trace element levels is important to understanding their impact on recombinant protein production and product quality.
This informational general chapter will discuss important topics relevant to establishing a trace element monitoring process that include:
Strategies for identifying trace elements of interest in cell culture media
Development of a risk assessment process for presence and concentration of trace elements in cell culture media
Media component sample considerations and sampling procedures
Analytical techniques and considerations important to measuring trace elements in cell culture media
A case study with a simple cell culture media is also provided to demonstrate and discuss commonly observed issues when a trace element program is implemented.
Source from USP and Please refer to USP for details:
RTU(ready to use) 2ml COP vial
Polymer Vial for cell and gene therapies
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