iPSC Release Testing
Our Expertise
Our state-of-the-art analytical platforms support the characterization of iPSCs through genomic integrity assessment, sterility and mycoplasma testing, and pluripotency validation. With expertise in GMP-compliant testing, we help you confidently advance your iPSC-based therapies from research to clinical use.
Key iPSC Services
CQA
Assay
Description
Platform
Pluripotency Surface Marker Profiling
Confirm undifferentiated pluripotent stem cells by detecting SSEA-4⁺ and TRA-1-60⁺ expression with SSEA-1⁻ absence.
Flow Cytometry
Identity
Pluripotency Marker Gene Expression
Confirm undifferentiated stem cell identity by measuring TF expression of OCT4, SOX2, and NANOG.
qPCR
STR-Based Genetic Identity Profiling
Verify iPSC genetic identity by profiling highly polymorphic DNA regions using STR analysis.
Sanger
HLA Genotyping
Confirm sample identity by genotyping HLA loci for accurate verification.
NGS
Ectoderm Marker Expression
Confirm ectodermal differentiation potential by measuring SOX1, PAX6, and NESTIN, markers of neural specification.
qPCR
Potency
Mesoderm Marker Expression
Confirm mesodermal differentiation potential by measuring BRACHYURY, NKX2-5, and HAND1, mesoderm markers.
qPCR
Endoderm Marker Expression
Confirm endodermal differentiation potential by measuring SOX17, FOXA2, and CXCR4, endodermal markers.
qPCR
Residual Episomal Plasmid (EBNA1)
Quantify residual episomal plasmids with EBNA1; EBNA1 enables replication without integration and persistence.
ddPCR
Residual Episomal Plasmid (Ori)
Quantify residual episomal plasmids containing the Ori element, the binding site for EBNA1 that enables replication.
ddPCR/qPCR
Residual Reprogramming Vector (Custom)
Quantify residual custom episomal reprogramming vectors to ensure clearance from cells.
ddPCR
Residual Reprogramming Vector (Sendai)
Quantify residual Sendai viral RNA, a non-integrating vector delivering reprogramming factors during iPSC generation.
ddPCR
Purity
Residual Total Collagenase
Quantify residual total collagenase in cell preps and biologics by antibody detection of active/inactive enzyme.
ELISA
Residual Medium Components
Quantify residual custom medium components to ensure clearance from cell preparations.
ELISA (Custom)
Residual ROCK Inhibitor (Y-27632)
Quantify residual ROCK inhibitor Y-27632 in cell preparations to ensure clearance from final products.
LC-MS
Residual Trypsin Activity
Quantify residual trypsin activity in cell preparations using the BAPNA colorimetric assay.
Colorimetric
Lineage Marker Exclusion
Confirm undifferentiated stem cell state by detecting the absence of lineage-specific differentiation markers.
qPCR
WGS Variant Detection
Detect genomic variants in coding and non-coding regions: structural, copy number, single-nucleotide.
NGS
WES Variant Detection
Detect cancer- and disease-associated variants in coding regions.
NGS
Bovine-Origin Adventitious Viruses
Detect bovine-origin adventitious viruses to identify potential contaminants in biologics or cell substrates.
qPCR (Panel)
Human-Tropic Adventitious Viruses
Detect human-tropic adventitious viruses via cytopathic effects and replication in permissive MRC-5 cells.
Cell Culture
Broad-Spectrum Adventitious Viruses
Detect broad-spectrum adventitious viruses via cytopathic effects and replication in permissive Vero cells.
Cell Culture
Avian/Broad-Spectrum Adventitious Viruses
Detect avian and broad-spectrum adventitious viruses via cytopathic effects and replication in permissive CEF cells.
Cell Culture
Human-Origin Adventitious Viruses
Detect human-origin adventitious viruses derived from human sources in biologics or cell substrates.
qPCR (Panel)
Safety
Porcine-Origin Adventitious Viruses
Detect porcine-origin adventitious viruses derived from porcine sources in biologics or cell substrates.
NGS (Panel)
Genetic Integrity Screening
Screen genetic integrity with the Illumina TruSight Inherited Disease Panel, detecting variants in genes linked to disease.
NGS (Panel)
Residual Active Collagenase
Quantify residual active collagenase in cell preps or biologics using the substrate-cleavage–dependent EnzChek™ assay.
Fluorometric
Residual DMSO
Quantify residual DMSO in cell preps with the Purpald® assay, detecting aldehyde formation followed by colorimetric rxn.
Colorimetric
Telomere Length Analysis
Quantify telomere length by calculating the T/S ratio (telomere repeat copy number to single-copy gene).
qPCR
Endotoxin Testing
Endotoxin testing per USP <85>
LAL Assay
Mycoplasma Testing
Mycoplasma detection per USP <63>
PCR/Micro
Sterility Testing
Standard sterility testing per USP <71>
Micro
Alkaline Phosphatase Staining
Confirm stem cell identity by detecting alkaline phosphatase activity inherent to undifferentiated stem cells.
Colorimetric
Other
Trypan Blue Viability Assay
Viability measurement using Trypan Blue: penetrates compromised membranes of non-viable cells.
Microscopy
7-AAD Viability Assay
Confirm cell viability by detecting 7-AAD penetration into non-viable cells with intact viable cells remaining unstained.
Flow Cytometry