GMP iPSC Production Service: Clinical-grade Human iPSCs and GMP MCBs

Beyond Testing: Built-in Genomic Assurance

Unlike standalone assays, REPROCELL embeds genetic integrity analysis directly into the development of every StemRNA™ Clinical iPSC Seed Clone bank and GMP MCB and WCB.

This integrated pipeline systematically identifies pathogenic and likely pathogenic variants—whether inherited from the donor or acquired during reprogramming and expansion—ensuring a higher standard of genomic quality from the earliest stages of cell line development.

Each Seed Clone is supported by a comprehensive OncoPanel report, providing continuity and confidence from donor material through to downstream GMP Master Cell Bank (MCB) or Working Cell Bank (WCB) generation.

This includes whole genome sequencing (WGS)-based screening with targeted analysis of over 400 cancer-associated genes, enabling the detection of high-impact variants in key genes, such as TP53, BCOR, KRAS, and DNMT3A, for comprehensive assessment of genomic stability and tumorigenicity risk.

Feature	REPROCELL OncoPanel	Typical OncoPanel Assays
Gene Coverage	WGS with targeted analysis of 400+ cancer associated genes	Limited panels (~50–100 genes) or targeted sequencing only
Regulatory Alignment	Aligned with FDA draft guidance recommending WGS for genomic integrity assessment	Not consistently aligned with WGS-based recommendations
Model	Included for evey cell bank	Performed as an on-demand test
Scope	Donor cells → iPSC → MCB	Typically single timepoint/sample
Output	Concise, clinically contextualized report	Often reported with limited clinical context

High-resolution Oncogenic Screening at Scale

REPROCELL's OncoPanel platform uses WGS-based analysis to evaluate genetic variants across more than 400 cancer-associated genes.

This expanded coverage enables:

Detection of rare and emerging oncogenic mutations
Broader risk assessment than targeted panels
Greater confidence in clinical translation

Traditional panels are limited in scope.

REPROCELL combines broad genomic coverage with deep analytical resolution to meet clinical application requirements.

Integrated Genetic Integrity Testing

Each clone undergoes testing of chromosomal analysis and OncoPanel Genomic Screening to ensure both structural and sequence-level stability.

From Raw Data to Actionable Decisions

Each OncoPanel report identifies high-impact variants and their clinical relevance using curated clinical databases.

Analysis includes:

Identification of high-impact variants
Annotation using public clinical databases (e.g., ClinVar, COSMIC)
Prioritization of variants relevant to safety and tumorigenicity

This supports that only actionable, high-confidence findings inform your development decisions into IND-enabling studies, regulatory submissions,
and risk assessment strategies.

What You Receive

Comprehensive OncoPanel report

Variant classification and interpretation

Chromosomal analysis results

Integrated donor-to-MCB traceability

Documentation suitable for regulatory use

Additional Service:

Custom variant analysis of donor and seed bank WGS data
Tailored analyses for disease-specific applications

Testing is performed within REPROCELL’s GMP-aligned processes, ensuring:

Full traceability
Documentation readiness
Alignment with regulatory expectations

Choose StemRNA™ Clinical iPSC Seed Clones with built-in genetic integrity assurance, so you can focus on advancing your therapy. To request more information, please fill out the inquiry form below.