We are starting a new category “cell product” dedicated to cell therapy products development and assessment.
Cell product is defined as any cell-based product involving live cells ‘produced’ ex vivo intended for therapy.
I’d like to start from the excellent review – Isolation and production of cells suitable for human therapy: challenges ahead.
In this commentary we highlight challenges related to cell sourcing and manufacturing of cellular products, all of which represent timely issues, given the relatively rapid progress in this field.
We outline challenges that may vary across different models of cell therapy, including the following broad concepts: issues related to the sourcing of material, and issues related to product manufacturing, shipping, storage and tracking, and standardization.
About importance of assays:
To ensure that a therapeutically effective dose of cells is administered as per recommendations, the manufacturing process for allogenic cells or small molecule therapeutics requires that each lot of cells or drug is similar to previous/subsequent lots and that there are unambiguous tests to predict the activity of each batch. Tests of this sort and surrogate measures of efficacy are routinely developed for drugs and will likely also be a regulatory requirement for cell therapy.
You can read full text in open access.
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