Standard Methods for Quality Control in Cell-Based Medicinal Products and their Validation for Clinical Applications.

In recent years, cell-based medicinal products (CMPs) have emerged as novel therapeutics with specific potential to treat a wide range of diseases. These products should be produced in accordance with good manufacturing practices (GMPs) and follow specific guidelines to ensure their safety and meet standard quality control criteria. This manuscript reviews current standard methods for quality control and validation specific to CMPs intended for clinical applications. We summarize critical quality attributes, including safety assessments such as sterility, endotoxin, mycoplasma, viral testing, tumorigenicity, and genetic stability; quantitative parameters, including cell counts and dose determination; and quality characteristics encompassing cell viability, morphology, growth kinetics, and immunophenotyping. We also address purity evaluation, potency assays, and the importance of validating analytical methods to guarantee reproducible and reliable test results. Furthermore, this article discusses necessary considerations for donor screening, raw material sourcing, manufacturing environment monitoring, and stability testing to maintain product integrity throughout production and storage. Emphasis is placed on adherence to GMP and relevant regulatory guidelines as defined by international pharmacopeias and authorities, such as the Food and Drug Administration and the European Medicines Agency. Finally, we highlight challenges faced in standardizing quality control for CMPs and underscore the need for continued development of rapid and robust testing methods tailored to their unique characteristics. This comprehensive overview aims to support academic and industrial stakeholders in implementing effective quality control strategies for advanced cell-based therapies.