Induced Pluripotent Stem Cell (iPSC) Characterization Service

Given the critical applications of induced pluripotent stem cells (iPSCs)—spanning differentiation into diverse lineages (e.g., neurons, cardiomyocytes) for drug discovery, disease modeling, and research—ensuring their quality is paramount. Our specialized characterization service directly addresses this imperative, employing rigorous protocols to verify key quality attributes. Comprehensive assessment confirms molecular identity, assures genomic stability, and validates functional competence. Such meticulous validation provides documented assurance of cell line integrity and functional reliability, critical for reproducible outcomes in demanding experimental contexts. Formal inquiry can yield detailed specifications on the validation assays, consultation options, and pricing structures designed to meet specific quality assurance requirements for research projects.

Our iPSCs Characterization Service

Our services encompass internationally recognized pluripotency assessment methods, including but not limited to:

• Molecular Marker Assay

Assessment of core pluripotency critically relies upon the rigorous detection and quantification of established molecular markers. Our analytical strategy integrates multiple technical modalities to achieve this. We employ quantitative reverse transcription PCR (RT-qPCR) for transcriptomic evidence, complemented by immunocytochemistry (ICC) and flow cytometry for protein-level expression analysis and population homogeneity assessment. This approach generates comprehensive expression data for key pluripotency factors—notably OCT4, NANOG, SOX2—and the characteristic surface antigen SSEA4. Utilization of this multi-parametric methodology ensures robust validation of individual iPSC lines. Ultimately, it provides definitive confirmation of their undifferentiated state, which is the essential foundation for their potential across diverse downstream research applications.

• In Vitro Directed Differentiation

Beyond static marker assessment, confirming functional pluripotency necessitates dynamic assays. We therefore utilize controlled in vitro directed differentiation protocols. These procedures rigorously evaluate the inherent capacity of the supplied iPSCs to generate cellular derivatives characteristic of all three primary germ layers: endoderm, mesoderm, and ectoderm. Successful demonstration of this trilineage differentiation potential serves as crucial validation. It unequivocally confirms that the cells possess the fundamental developmental plasticity essential for their effective deployment in downstream, lineage-specific applications.

• Karyotyping

Genetic fidelity is paramount. Rigorous assessment of both originating primary cells and resultant iPSC lines is therefore essential to validate authenticity and confirm genomic normalcy—prerequisites for reliable downstream applications. This comprehensive genomic surveillance employs a tiered analytical strategy. Conventional karyotyping addresses macro-level chromosomal integrity. Subsequently, high-sensitivity techniques, particularly copy number variation (CNV) analysis, are crucial for resolving submicroscopic genomic lesions, thereby completing a thorough appraisal of genetic stability.

• In Vivo Teratoma Formation

The in vivo teratoma assay, widely recognized as the gold standard, definitively confirms functional pluripotency. This assessment involves iPSC xenotransplantation into immunodeficient mice, with subsequent histological analysis rigorously verifying trilineage differentiation—encompassing endoderm, mesoderm, and ectoderm derivatives—within the resultant tumors. Crucially, beyond validating pluripotency, these teratomas provide a unique platform for investigating in vivo differentiation pathways and enable the isolation of specific progenitors (e.g., neural stem cells) for generating stable, patient-specific cell lines vital for disease modeling and advancing translational research.

Fig.1 Immunofluorescence images of iPSCs stained with pluripotency markers.¹

Fig.2 Images of tissues from the three germ layers in iPSC-derived teratomas.¹

All of our characterization experiments are conducted in accordance with stringent quality control standards, which include providing a complete Certificate of Analysis (CoA) and detailed experimental reports. This ensures the reliability and traceability of our data. If you would like to learn more about our services or request a quote, please don't hesitate to contact us. We're here to assist you!

Reference

1. Cheng, Yu‐Shan, et al. "A protocol for culture and characterization of human induced pluripotent stem cells after induction." Current protocols 3.8 (2023): e866. Distributed under Open Access license CC BY 4.0, without modification.