Analytical Characterisation of Cell-Based Medicinal Products

Cell-based medicinal products (CBMPs) are complex therapeutic products requiring robust analytical characterisation to ensure their quality, safety, and efficacy. Their development involves challenges such as controlling cell variability, managing complex manufacturing processes, and complying with regulatory expectations. Analytical methods must address key attributes including identity, purity, biological activity, viability, and concentration. In this context, validated approaches combining multiple analytical techniques are essential to support product development and release.

This application note presents the development and validation of analytical methods adapted to CBMPs and is available for full download below.

KEY HIGHLIGHTS OF THE METHOD

• Development and validation of analytical methods covering identity, purity, biological activity, viability and cell concentration
• Flow cytometry assays validated according to ICH Q2(R1) demonstrating specificity, linearity, accuracy, precision and sensitivity
• Quantification range established for surface markers between 0.5% and 100%, with defined limits of detection for each marker
• Intracellular marker analysis (Nanog, Oct3/4, Sox2) validated with linearity, accuracy and precision across a 1–100% range
• Multiplex Luminex assay optimised and validated for cytokine profiling (8-plex), demonstrating accuracy, precision, sensitivity and robustness, with no flanking effect observed

HOW THIS SUPPORTS YOUR CELL THERAPY PROGRAMME

The implementation of validated analytical methods is critical to ensure reliable characterisation of CBMPs throughout development and release. The approaches described in this application note support consistent data generation and regulatory compliance.

• Supports comprehensive product characterisation across identity, purity and potency attributes
• Enables robust method validation aligned with regulatory expectations (ICH Q2(R1), FDA and EMA guidance)
• Improves reliability of multiparametric analyses through flow cytometry and complementary techniques
• Facilitates detection and control of process-related and product-related impurities
• Enhances understanding of cellular functionality through biological activity assays and cytokine profiling
• Supports evaluation of differentiation status and functional properties of cell-based products

APPLICATIONS / USE CASES

• Characterisation of mesenchymal stem cells (MSCs) using flow cytometry and immunocytochemistry
• Analysis of intracellular transcription factors for embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs)
• Cytokine profiling for immune function assessment using multiplex Luminex assays
• Gene expression analysis by qPCR for identity and differentiation markers
• Evaluation of MSC differentiation into adipocytes, osteocytes, chondrocytes and hepatocyte-like cells
• Functional assessment of differentiated cells, including metabolic activity and marker expression