What is Quality Control and Why?
In stem cell research and manufacturing, quality control (QC) refers to the systematic processes used to verify that your stem cell cultures meet the required standards of purity, identity, consistency, and functionality.
Why Is Stem Cell Quality Control Important?
Whether you are reprogramming iPSCs, expanding hESCs, or preparing cells for downstream differentiation, maintaining quality is critical, not just for scientific integrity, but for reproducibility, regulatory compliance, and therapeutic safety.
Stem cells are inherently variable. Without proper QC, you risk working with mixed or spontaneously differentiated cultures, introducing significant variability into your experiments, assays, or clinical products.
Unchecked variability can lead to:
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Misleading experimental results
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Poor reproducibility across labs or batches
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Reduced efficacy in drug screening or therapeutic models
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Regulatory delays or failure in translational workflows

How Should You Perform Quality Control?
Quality control should be integrated at key checkpoints throughout your stem cell workflow:
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Pluripotency Verification: Confirm that your cells express established surface markers such as SSEA-3, SSEA-4, and Lewis X (SSEA-1). This is typically done using flow cytometry, immunocytochemistry, or ELISA with validated, specific antibodies.
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Culture Purity Assessment: Monitor the absence of unwanted differentiated cell types by regularly staining for pluripotency markers.
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Reprogramming Validation: During iPSC generation, screen colonies early for surface markers to ensure successful reprogramming.
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Batch-to-Batch Consistency: Use reproducible reagents, such as monoclonal antibodies with minimal cross-reactivity, to ensure consistent cell quality across experiments or production runs.
Quick Guide: Common Stem Cell Markers
See below for our quick guide on common cell surface and intracellular markers used to identify stem cells (both ESCs and iPSCs).
Understanding the differences between these marker types is essential for selecting the most appropriate tools for your workflow, assay format, and quality control requirements.
Choosing the Right Markers
Your choice between surface and intracellular markers should depend on:
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The stage of your workflow (e.g., reprogramming, expansion, or differentiation)
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The type of assay (live versus fixed cells)
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The goal of the experiment (phenotyping, cell sorting, or quality control)
For live-cell monitoring and sorting, surface markers are typically preferred.
For confirming transcriptional status and core pluripotency, intracellular markers are essential.
In many cases, combining both types offers the most comprehensive evaluation of stem cell identity and quality.
Cell Surface Markers
Examples: SSEA-3, SSEA-4, TRA-1-60, TRA-1-81, CD133, Lewis X/SSEA-1
Best suited for:
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Live-cell analysis such as flow cytometry or live imaging
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Non-destructive cell sorting (e.g., FACS or MACS)
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Routine monitoring of undifferentiated stem cell cultures
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Early screening during iPSC reprogramming
Advantages:
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Enable real-time, live-cell detection
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Allow for cell sorting or enrichment without affecting viability
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Suitable for high-throughput and scalable workflows
Considerations:
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Expression levels may vary between cell lines or change with passage
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Often used in combination for greater specificity and reliability
Intracellular Markers
Examples: Oct4, Sox2, Nanog, Klf4, c-Myc, Lin28
Best suited for:
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Confirming expression of key pluripotency transcription factors
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Applications using fixed cells (e.g., immunocytochemistry, immunofluorescence, Western blot)
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Assessing reprogramming efficiency at the molecular level
Advantages:
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Detect core regulators of pluripotency
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Offer deeper insight into transcriptional identity and cell state
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Useful for validating iPSC induction and maintenance of stemness
Considerations:
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Require fixation and permeabilization, so not compatible with live-cell assays
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Not suitable for sorting viable populations for downstream applications
Cell Surface Markers | Application |
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ABCG2 | Marker of pluripotency and multidrug resistance |
Alkaline Phosphatase | Enzyme highly expressed in pluripotent stem cells |
Cripto-1 | Important in early embryonic development and TGF-β signaling |
E-cadherin | Essential for pluripotent stem cell adhesion and colony formation |
Frizzled-5 | Wnt signaling receptor involved in stem cell maintenance |
Integrin alpha 6/CD49f | Maintains adhesion and self-renewal of pluripotent stem cells |
Integrin beta 1/CD29 | Regulates cell adhesion and interaction with the extracellular matrix |
PODXL/TRA-1-81 | Pluripotency marker and regulator of cell adhesion |
SSEA-1 | Pluripotency marker in mouse ESCs and differentiation marker in human ESCs |
SSEA-3 | Marker of undifferentiated human ESCs and iPSCs |
SSEA-4 | Pluripotency marker in human ESCs and iPSCs |
TRA-1-60 | Marker of undifferentiated human ESCs and iPSCs |
Intracellular Markers | Application |
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FoxD3 | Neural crest development and pluripotency maintenance |
KLF2 | Transcription factor regulating self-renewal and pluripotency |
KLF5 | Maintains pluripotency and self-renewal in ESCs |
LIN-28A | Regulates let-7 miRNA processing, maintaining pluripotency |
c-Myc | Transcription factor promoting cell proliferation and reprogramming |
Nanog | Master regulator of pluripotency in ESCs and iPSCs |
Oct-3/4 | Core pluripotency transcription factor |
Rex-1 | Transcription factor associated with undifferentiated state of ESCs |
SOX2 | Core transcription factor essential for maintaining pluripotency |
STAT3 | Regulates self-renewal of ESCs via LIF signaling |
SUZ12 | Component of PRC2 complex, regulating epigenetic silencing |
TCF-3/TCF7L1 | Wnt signaling regulator and transcription factor in ESCs |
UTF1 | Regulates self-renewal and differentiation potential in ESCs |
Featured Antibodies for Stem Cell Quality Assurance
Amsbio has expanded its portfolio of high-performance monoclonal antibodies to support standardization, pluripotency validation, and quality control in both academic stem cell research and industrial regenerative medicine workflows.
Our newest additions target well-established surface markers of human pluripotent stem cells: SSEA-3 (Gb5), SSEA-4 (SialylGb5), and Lewis X (SSEA-1), essential tools for confirming undifferentiated states, monitoring early differentiation, and maintaining reproducibility across laboratories and production batches.
These antibodies are highly specific, application-validated, and available in a variety of conjugated forms to suit your experimental needs.

Key Features
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Monoclonal Antibodies Against Key Pluripotent Markers: Raised against unique glycan structures found specifically on hESCs and hiPSCs.
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Validated Specificity and Low Cross-reactivity: ELISA-based specificity testing confirms minimal cross-reactivity with related glycans (e.g., Anti-SSEA-3 shows no reactivity with Gb3, Gb4, or Gb5), ensuring accurate signal detection.
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Certified and Application-Ready: Supplied with validation data and certification upon request to support regulatory compliance and QC documentation.
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Clone Information Provided: Each product includes detailed clone data (e.g., MC-631 for Anti-SSEA-3, MC-813-70 for Anti-SSEA-4) for transparency and batch reproducibility.
Compatible Workflows and Applications
These antibodies are designed for use with human embryonic stem cells (hESCs) and induced pluripotent stem cells (hiPSCs) across a range of quality control and research workflows:
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Flow Cytometry – Rapid live-cell assessment of pluripotency markers
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Immunocytochemistry (ICC) – Fixed-cell staining to visualize marker expression
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ELISA – Quantitative validation and cross-reactivity screening
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Western Blotting (WB) – Protein-level confirmation of pluripotent marker expression
Benefits for Researchers and Industry
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Reliable Pluripotency Verification: Confirms the undifferentiated status of cultured stem cells with high confidence.
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Improved Stem Cell Quality Control: Helps standardize protocols across laboratories and manufacturing environments.
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Minimized False Positives: High specificity reduces non-specific binding, ensuring clear, interpretable results.
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Flexible Experimental Design: Compatible with diverse workflows in discovery research, translational studies, and regulated production.
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Reproducibility and Confidence: Consistent antibody performance supports long-term reproducibility across experiments and batches.
For a list of featured antibodies that we offer, please see below:
Product Name | Category | Clone ID | Species Reactivity | Application | Product Code |
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Anti-SSEA-3 (Gb5) Monoclonal Antibody | Cell Surface Marker | 18B4 | Human | ELISA, Flow cytometry, TLC-immunoblotting | AMS.A3729 |
Anti-SSEA-4 (SialylGb5) Monoclonal Antibody | Cell Surface Marker | 13D7 | Human | ELISA, Flow cytometry, TLC-immunoblotting | AMS.A3742 |
Anti-Lewis X Monoclonal Antibody | Cell Surface Marker | 73-30 | Human | ELISA, Flow cytometry, IHC, IP, WB, TLC-immunostaining. | AMS.A2578 |
StemAb Oct4 Antibody | Intracellular Marker | - | Mouse/Human | IHC and Flow cytometry | AMS.09-0023 |
StemAb Anti human Nanog antibody | Intracellular Marker | - | Human | IF | AMS.RCAB004P-F |
Anti-SOX2 Antibody | Intracellular Marker | 57CT23.3.4 | Human | WB, IF, Flow Cytometry, IHC-P | M00105-3-400ul |
PODXL Mouse Monoclonal Antibody | Cell Surface Marker | TRA-1-60(R) | Human | ELISA, FC, ICC/IF, IHC, IP, WB | TA301484 |
PODXL Mouse Monoclonal Antibody | Cell Surface Marker | TRA-1-81 | Human | ELISA, FC, ICC/IF, IHC, IP, WB | TA301485 |
Anti-KLF5 Mouse Monoclonal | Intracellular Marker | OTI6D | Human/Mouse/Rat | IHC, WB | M00727 |
Anti-KLF2 Mouse Monoclonal Antibody | Intracellular Marker | OTI3D12 | Human/Mouse/Rat | WB | M01046-1 |
Anti-c-Myc Antibody | Intracellular Marker | OTI1A6 | Human | IHC,ICC,WB | MA1028 |
anti- STAT3 antibody | Intracellular Marker | 6A9 | Human/Mouse | WB, IHC, IF, IP, ELISA | AMS.FNab08300 |
Stem Cell Testing Kits for Quality Control and Pluripotency Assessment
Reliable quality control is essential in both stem cell research and manufacturing to ensure the accuracy, reproducibility, and safety of your cultures. Amsbio offers a range of testing kits to support two critical areas of stem cell quality assessment: contamination detection and pluripotency validation.

MycoScopeâ„¢ PCR Mycoplasma Detection Kit
The MycoScopeâ„¢ kit provides a fast and sensitive method for detecting mycoplasma contamination in cell cultures using PCR.
Key Features:
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Rapid Turnaround: Delivers results in under 3 hours, enabling quick and efficient contamination screening.
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High Sensitivity: Capable of detecting fewer than 5 mycoplasma genomes per microliter of sample.
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No DNA Purification Required: Simple workflow using cell culture supernatants directly.
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Comprehensive Coverage: Detects all common mycoplasma species using primers targeting the conserved 16S rRNA region.
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Clear Result Interpretation: Distinct 500 bp band in PCR gel readout indicates contamination.
Typical Applications:
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Routine monitoring of stem cell cultures
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Quality control before banking or downstream applications
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Screening of new culture media, reagents, or lines
Product Page: MycoScopeâ„¢ PCR Mycoplasma Detection Kit

StemAbâ„¢ Alkaline Phosphatase Staining Kit II
This staining kit is used to assess the undifferentiated state of embryonic stem (ES) and induced pluripotent stem (iPS) cells by detecting alkaline phosphatase activity, a hallmark of pluripotency.
Key Features:
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Sensitive Pluripotency Marker: Detects alkaline phosphatase, which is highly expressed in undifferentiated hESCs and hiPSCs.
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Clear Visual Differentiation: Undifferentiated colonies stain red to purple; differentiated cells remain colorless.
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Validated for Stem Cell Use: Functionally tested on human iPS and mouse ES cells.
Typical Applications:
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Routine monitoring of culture pluripotency
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Screening reprogrammed colonies for undifferentiated status
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Early-stage differentiation studies
For a list of applicable kits that we offer, please see below:
Product Name | Category | Application | Product Code |
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MycoScopeâ„¢ PCR Mycoplasma Detection Kit (50) | Mycoplasma testing | PCR | AMS.MY01050 |
MycoScopeâ„¢ PCR Mycoplasma Detection Kit (100) | Mycoplasma testing | PCR | AMS.MY01100 |
StemAb Alkaline Phosphatase Staining Kit II | Intracellular Marker | Cell staining | AMS.00-0055 |
Human Transcription factor SOX-2(SOX2) ELISA kit | Intracellular Marker | ELISA | AMS.E01T0646 |
Human NANOG/Homeobox protein NANOG ELISA Kit | Intracellular Marker | ELISA | AMS.E14436h |
Human OCT4(Octamer Binding Transcription Factor 4) ELISA Kit | Intracellular Marker | ELISA | AMS.ELK5047-1 |