Controlling process-related impurities is one of the most critical challenges in cell therapy development. Unlike traditional biologics, cell therapies have limited purification options, making residuals a defining quality and safety concern. This document provides a strategic framework, designed for both scientists developing these therapies and the regulators reviewing them, for identifying, characterizing, and mitigating impurities across therapeutic cell types. It combines empirical, mathematical, and regulatory perspectives with practical case examples to guide developers through risk assessment, clearance strategies, and analytical method design.

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