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

Elahe Mahmoodi Khaledi1, Azam Samadian2,3, Narges Sabahi Moosavi2,3

  • 1Department of Cell and Molecular Biology, Faculty of Chemistry, University of Kashan, Kashan, Iran.

Advanced Biomedical Research
|July 10, 2026
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Summary

This review outlines essential quality control methods for cell-based medicinal products (CMPs) to ensure safety and efficacy. It covers critical attributes, manufacturing practices, and regulatory guidelines for advanced cell therapies.

Keywords:
Cell-based medicinal productsidentitypotencypurityqualityquality controlsafetyvalidation

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Area of Science:

  • Biotechnology and Pharmaceutical Sciences
  • Regenerative Medicine
  • Cell Therapy Manufacturing

Background:

  • Cell-based medicinal products (CMPs) offer novel therapeutic potential across various diseases.
  • Ensuring the safety, quality, and efficacy of CMPs requires adherence to stringent Good Manufacturing Practices (GMPs) and specific regulatory guidelines.
  • Standardized quality control (QC) methods are crucial for the clinical application of these advanced therapies.

Purpose of the Study:

  • To review current standard methods for quality control and validation of CMPs for clinical use.
  • To summarize critical quality attributes, including safety, quantitative, and qualitative characteristics.
  • To highlight challenges and the need for developing robust QC methods for CMPs.

Main Methods:

  • Review of current literature and regulatory guidelines concerning CMP quality control.
  • Summarization of critical quality attributes: safety (sterility, tumorigenicity, etc.), quantitative (cell count, dose), and quality (viability, morphology, immunophenotyping).
  • Discussion of raw material sourcing, manufacturing environment, donor screening, and stability testing.

Main Results:

  • Identified key QC parameters including purity, potency assays, and analytical method validation.
  • Emphasized the importance of GMP compliance and adherence to guidelines from regulatory bodies like the FDA and EMA.
  • Highlighted challenges in standardizing QC for CMPs and the need for rapid, robust testing methods.

Conclusions:

  • Effective quality control strategies are vital for the successful implementation of cell-based therapies.
  • Standardization of QC methods and development of advanced testing are necessary to overcome current challenges.
  • This review provides a comprehensive overview to support stakeholders in establishing robust QC for CMPs.