Abstract
The quickly developing cellular therapy field presents a wide range of challenges to Quality Control (QC) testing platforms. Biological diversity of subjects, novel manufacturing process designs, and quickly evolving analytical methods all introduce variation into quickly changing product characterization platforms. Although these challenges can exist at all levels of product development pipeline, they may have the greatest effect on the Phase 1 manufacturing environment. Minimizing the impact of sample-introduced variability, such as variation in composition and modified cell stability, through standardization of sampling processes is a key strategy for maximizing quality control of cell therapy products. By evaluating sample collection method suitability and adjusting for non-cellular constituents, and by standardizing sample handling practice, sampling plans can be designed that best represent cell therapy final products, ensuring product safety and suitability for release.
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