iPSC Testing Services
iPSC Testing Services
Induced pluripotent stem cells (iPSCs) hold immense potential for regenerative medicine, cell therapy, and drug discovery, but ensuring their safety, identity, and potency is essential at every stage of development. At Avance Biosciences, we offer comprehensive iPSC testing, including regulatory compliant release assays as well as in-depth characterization and analytical support, to help you advance your programs with confidence.
Our Expertise
Leveraging state-of-the-art analytical platforms, we provide comprehensive iPSC assessment, including genomic integrity, sterility and mycoplasma testing, pluripotency validation, and residual reagent profiling. With expertise in GLP- and GMP-compliant testing, we help you confidently advance iPSC-based therapies from early research through clinical development.
Key iPSC Services
CQA
Assay
Description
Platform
Identity
Pluripotency Surface Marker Profiling
Confirm undifferentiated pluripotent stem cells by detecting SSEA-4⁺ and TRA-1-60⁺ expression with SSEA-1⁻ absence.
Identity
Pluripotency Marker Gene Expression
Confirm undifferentiated stem cell identity by measuring TF expression of OCT4, SOX2, and NANOG.
STR-Based Genetic Identity Profiling
Verify iPSC genetic identity by profiling highly polymorphic DNA regions using STR analysis.
Potency
Ectoderm Marker Expression
Confirm ectodermal differentiation potential by measuring SOX1, PAX6, and NESTIN, markers of neural specification.
Potency
Mesoderm Marker Expression
Confirm mesodermal differentiation potential by measuring BRACHYURY, NKX2-5, and HAND1, mesoderm markers.
Endoderm Marker Expression
Confirm endodermal differentiation potential by measuring SOX17, FOXA2, and CXCR4, endodermal markers.
Purity
Residual Episomal Plasmid (EBNA1)
Quantify residual episomal plasmids with EBNA1; EBNA1 enables replication without integration and persistence.
Residual Reprogramming Vector (Custom)
Quantify residual custom episomal reprogramming vectors to ensure clearance from cells.
Residual Reprogramming Vector (Sendai)
Quantify residual Sendai viral RNA, a non-integrating vector delivering reprogramming factors during iPSC generation.
Purity
Residual Total Collagenase
Quantify residual total collagenase in cell preps and biologics by antibody detection of active/inactive enzyme.
Residual Medium Components
Quantify residual custom medium components to ensure clearance from cell preparations.
Residual ROCK Inhibitor (Y-27632)
Quantify residual ROCK inhibitor Y-27632 in cell preparations to ensure clearance from final products.
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.
Safety
WGS Variant Detection
Detect genomic variants in coding and non-coding regions: structural, copy number, single-nucleotide.
Bovine-Origin Adventitious Viruses
Detect bovine-origin adventitious viruses to identify potential contaminants in biologics or cell substrates.
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.
Safety
Porcine-Origin Adventitious Viruses
Detect porcine-origin adventitious viruses derived from porcine sources in biologics or cell substrates.
Genetic Integrity Screening
Screen genetic integrity with the Illumina TruSight Inherited Disease Panel, detecting variants in genes linked to disease.
Residual Active Collagenase
Quantify residual active collagenase in cell preps or biologics using the substrate-cleavage–dependent EnzChek™ assay.
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).
Endotoxin Testing
Endotoxin testing per USP <85>
LAL Assay
Other
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.
