iPSC Release Testing

Induced pluripotent stem cells (iPSCs) hold immense potential for regenerative medicine, cell therapy, and drug discovery, but ensuring their safety, identity, and potency is critical before clinical application. At Avance Biosciences, we provide comprehensive iPSC release testing services to meet stringent regulatory requirements.

Our Expertise

Our state-of-the-art analytical platforms support the characterization of iPSCs through genomic integrity assessment, sterility and mycoplasma testing, pluripotency validation, and karyotyping. With expertise in GMP-compliant testing, we help you confidently advance your iPSC-based therapies from research to clinical use.

Key iPSC Services

Critical Quality Attributes

Assay

Description

Platform

Sterility

USP <71>

Culture-based Compendial Microbiology

Endotoxin

USP <85>

Biochemical-based Compendial Microbiology

Safety

Bioburden

USP <61>, <62>

Culture-based Compendial Microbiology

Mycoplasma

USP <63>

Culture-based Compendial Microbiology

Viral Testing

USP <1237>

Multiplex QPCR and/or Next-gen Sequencing (NGS)

Disease Marker Analysis (oncopanel, tumorigenicity)

Detect oncogenic and disease-associated mutations to assess tumorigenic risk. High-depth sequencing is used to ensure sensitive and comprehensive variant detection

Next-gen Sequencing (NGS)

Purity

Residual Vector Testing

Confirmation of presence and copy number of reprogramming vectors

qPCR / ddPCR

Residual Contaminating Cells

Determination of percentage of non-iPSC subsets in samples

Flow Cytometry

STR Profiling Analysis

Generation of STR profiles for source tissue/cells, iPSC seed, and Master Cell Bank

Capillary electrophoresis (CE)

Pluripotency Markers

Immunophenotyping of cells by flow cytometry using the standard hPSC panel (including OCT4, TRA-1-60, TRA-1-81, SSEA-3, SSEA-4, Sox2, Nanog, etc.)

Flow Cytometry

Identity/Genetic stability

Pluripotency Markers

Analysis of hPSC Scorecard Panel gene expression

qPCR

Cell Specific Markers

Assessment of additional cell markers as required

Flow Cytometry

Karyotype

Currently, not offering G-Banding. For alternative method, contact for more details.

Imaging

SNP Genotyping

High-resolution genomic profiling for verification of cell identity and contamination detection

Next-gen Sequencing (NGS)

HLA Typing

Typing of HLA loci for donor verification and immune compatibility assessment

Next-gen Sequencing (NGS)

Viability

Cell Count & Viability

Measurement of cell viability and quantification

NC200 Cell Counter

Doubling Time

Determination of cell population doubling time during culture

NC200 Cell Counter

Potency

Phenotypic Pluripotency

Development and validation of custom assays for potency determination; contact for details

Assays tailored to customer requirements and MOA-specific needs (e.g., qPCR, ddPCR, NGS, ELISA, LC-MS).

Molecular Pluripotency

Development and validation of custom cell-based potency assays; contact for further information

Assays tailored to customer requirements and MOA-specific needs (e.g., qPCR, ddPCR, NGS, ELISA, LC-MS).

Have Questions?

We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a quick message with your questions to find out what Avance can do for you.