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IDD Services
NAM-Assay Services backed by In-House Cell Generation
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YBL-IDD generates human iPSC lines and primary cells and deploys them in assay services - each defined by a clear regulatory context of use, from liver toxicity profiling to drug discovery and personal care in vitro assay services
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-Relevant Biology Requires Regulatory Context
Using human cells alone does not guarantee predictive or regulatory-relevant outcomes. Effective NAMs must combine biological relevance with a clearly defined scientific and regulatory purpose. At YBL-IDD, we design assays around the specific decision they are intended to support — from early screening to translational validation.
Context of Use Defines Assay Value
A scientifically robust assay delivers impact only when its Context of Use (COU) is clearly established. Regulatory agencies increasingly evaluate NAMs based on the precise question being addressed, the stage of development, and the intended application in decision-making or submissions.
Clinical Relevance Must Be Demonstrated
Human-relevant does not automatically mean clinically predictive. True translational value comes from demonstrated concordance with known human outcomes, reference datasets, or mechanistic evidence. YBL-IDD focuses on fit-for-purpose assay strategies that strengthen confidence in downstream development decisions.
Designed for the Right Level of Regulatory Confidence
Many CROs position assays as “human-relevant” without distinguishing between exploratory biology, translational relevance, and regulatory applicability. YBL-IDD develops each workflow with the appropriate level of validation, mechanistic rigor, and evidentiary support aligned to your program stage and regulatory goals.
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.
Liver Toxicity Assays – Oxidative stress, mitochondrial dysfunction, fat metabolism, and phase II metabolic enzyme services for hepatotoxicity screening and mechanistic profiling.
Drug Discovery Assays – Cell-based assay services covering cytotoxicity, proliferation, receptor pharmacology, mechanism of action, and disease modelling for early compound screening.
Personal Care Assays – Human cell-based testing services for cosmetic and personal care actives — pigmentation, collagen, anti-aging, antioxidant, and wound repair assays.
Custom CiVM Development – Bespoke complex in-vitro model design and validation for disease areas with no existing animal model — co-culture systems and disease-in-a-dish approaches.
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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
1. Scientific Scoping — Disease biology mapping, assay architecture design, readout selection for your indication
2. Cell Source & Characterisation — Human cells selected, differentiated or isolated, and validated under our QMS
3. Context-relevant Model Assembly — Physiologically relevant multi-cell assay system established and validated
4. Compound Testing & Functional Readout — High-content imaging, ELISA, or electrophysiology with your test compounds
5. Regulatory-Ready Data Package — Statistical analysis, methodology documentation, and full study report
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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