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IDD Services
NAM-Assay Services backed by In-House Cell Generation
YBL-IDD generates human iPSC cell lines and deploys them in assay services — each defined by a clear regulatory context of use, from CiPA-validated cardiac safety profiling to liver toxicity and drug discovery.
Why YBL-IDD NAM Services?
Human Relevance, Clinical Relevance, and Context of Use — All Three Matter at YBL-IDD
YBL-IDD designs NAM services that combine human biology, clinical predictivity, and regulatory alignment — ensuring every assay delivers meaningful, decision-ready data.
Human Relevance - Necessary, But Not Sufficient
Using human cells is not the endpoint. An assay is human-relevant if it uses human biology - but that alone does not guarantee it predicts a clinical outcome or satisfies a regulatory submission requirement. The biology must be matched to the right question.
Clinical Relevance - The Higher Bar
Clinical relevance requires demonstrated concordance with known human clinical outcomes - not just the use of human cells. Only assays validated against clinical reference datasets, such as under the CiPA paradigm, carry this designation. It is earned, not assumed.
Context of Use - The Regulatory Frame
A context of use defines precisely what question an assay is intended to answer, at what stage of development, and for what regulatory purpose. Without a defined CoU, even a technically excellent assay may carry limited weight in a regulatory submission or go/no-go decision.
Most CROs Don't Distinguish Between Them
Conflating human-relevant with clinically relevant - or offering assays without a defined context of use - gives sponsors false confidence and data that cannot be acted on. YBL-IDD designs every service around the right level of claim for the right stage of your program.
IDD NAM Services – From Cells to Assays
- iPSC Line Generation & Characterization
- Primary Cell Isolation & Characterization
- Liver Toxicity Assays
- Drug Discovery Assays
- Personal Care Assays
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Upstream NAM Services – Cell Line Generation & Characterization
Most CROs source cells from third-party suppliers — introducing variability they cannot control. YBL-IDD generates human iPSC cell lines and isolates primary human cells in-house under one quality system.
The result is end-to-end data provenance, ensuring consistency and reliability.
• iPSC Line Generation & Characterization
We reprogram and expand iPSC lines in GMP-compliant environments and differentiate them into specialized assay-ready cells. Fully traceable and validated.
• Primary Cell Isolation & Characterization Services
We isolate and validate primary human cells with defined purity and viability — eliminating dependency on third-party suppliers.
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Downstream NAM Assay Services
Built on the cells we generate in-house — five assay service domains, all conducted under the same GMP quality system, by the same scientific team.
Custom In Vitro Model Development & Assay Services
Custom CiVM services occupy a distinct category: they are purpose-built for disease areas where no validated model exists and where the context of use is negotiated at the outset of each engagement.
YBL-IDD combines iPSC-derived and primary human cells into co-culture systems that are biologically meaningful — and we work with you to define what questions the model can and cannot answer, so data is interpreted within its appropriate scope.
This is not a catalogue service; it is a scientific collaboration with a defined deliverable.
CiVM Service Workflow
Tell Us Your Scientific Question. We'll Tell You Which Model & Service It Fits.
Whether you need CiPA-validated cardiac safety data for a regulatory submission, early-stage DILI screening, human-relevant personal care assays, or a bespoke CiVM for an indication with no animal model - the conversation starts with defining your context of use. Talk to our scientists.
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