Media fingerprinting of cell culture media a standardized analytical test method suite and three-tier approach

Cell culture media are comprised of a combination of compounds and nutrients designed to support cellular growth. They are complex raw materials used for manufacturing a variety of products in protein, cell and gene therapy modalities, as well as vaccines. Variations in cell culture media can significantly impact product quality and process performance leading to negative outcomes such as extensive and costly investigations.  

Cell culture processes are often more sensitive to variation in the cell culture media and the overall controls on the cell culture media become increasingly critical. A key element of the control strategy is the capability to effectively characterize or ‘fingerprint’ the cell culture media proactively.  

This paper gives a best practice recommendation for fingerprinting cell culture media. It includes a standardized analytical test method suite, a three-tier testing approach and flowcharts that guide the reader to choose a suitable media fingerprinting method based on their goals and the raw material properties. 

Although there cannot be a ‘one-size fits all’ approach to cell culture media fingerprinting, this paper outlines an approach where ‘a few sizes fit most’. Applying BioPhorum’s three-tier approach to characterization testing will benefit both media manufacturers and end-users.  

By understanding and using the resources available in this paper, media manufacturers/suppliers and biopharma end-users stand to gain deeper insight into their media and product/process capabilities and requirements, and let them focus their energies on ‘what matters most’ in relation to materials. This approach will result in improved knowledge that can make life-saving medicines even more effective.

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• Create Date 29th November 2022
• DOI https://doi.org/10.46220/2022DS006
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