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The Importance of Cell Media Analysis in Cell Therapy Development

One of the keys to cell therapy process development lies in the cell culture media used to culture the cells after isolation.

Read the other articles in this series: Metabolomics Analysis in Cell Therapy Development, Analyzing Serum-Free Media for Cell Therapy Applications, Spent Media Analysis to Improve Cell Therapy Manufacturing

In the field of regenerative medicine, cell and gene therapies are increasingly becoming viable therapeutic alternatives to traditional treatments for a wide range of diseases.

Most recently, T-cells have been the focus of much clinical investment with chimeric antigen receptor (CAR) T-cell immunotherapies for blood cancers, but other cell types including mesenchymal stem cells (MSCs) and other immune cells (i.e., NK cells, macrophages) have also been investigated for their therapeutic potential. Regardless of the cell type, understanding the best way to culture the cells in vitro to achieve optimal cell activation and expansion, while maintaining functionality is key to the success of these “living medicines”.

One of the keys to successfully producing a cell therapy product lies in the cell culture media used to culture the cells after isolation. Since each cell type has unique requirements that impact their growth, viability, and functionality, and the cell itself is the therapy, additional scrutiny of the media used during cell therapy development is necessary.

There is a wide range of cell culture media available from do-it-yourself recipes to commercially available one-size-fits-all complete formulations. It can be a challenging landscape to navigate when identifying the optimal culture media for your cell type because of the diversity of compositions and a multitude of options for each cell type.

Additionally, many companies developing cell therapies are looking to lower the very high cost of commercial cell therapy manufacturing for current autologous cell therapies. This is largely done by developing allogenic cell therapies which will allow better scalability and standardization but suffer from safety and efficacy issues. There are rigorous safety and regulatory guidances that restrict certain additives that could pose a health risk to patients, from inclusion in cell culture media. This has resulted in increased investment in developing xeno-free and/or chemically defined media alternatives.

Again, it is important to highlight the importance of cell culture media analysis in the development, manufacture and commercialization of any cell-based therapy. Overlooking this aspect and failing to plan appropriately can result in inconsistent performance and quality of the cell therapy and present roadblocks in moving it successfully through regulatory approval. These challenges can ultimately reduce speed to market, which is particularly critical to cell therapies.

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The Critical Role of Cell Culture Media Analysis in CGT Development

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