Pharma & Biotech

Human ex vivo NAMs for drug development

Find the right starting point for your program

Many conventional preclinical models fail to capture the complexity of living human skin — its tissue architecture, resident immune cells, donor variability, and route-specific responses. Genoskin’s ex vivo human skin models preserve that biological complexity, providing human-relevant NAM data earlier in development. By integrating Genoskin studies before more costly GLP programs, teams can compare candidates, refine formulations, assess local tissue response, and identify translational biomarkers — with greater confidence before entering resource-intensive regulatory testing.

Injectable therapeutics & biologics

Assess injection-site reactions, local tolerance, and immune responses in real human skin before first-in-human studies.

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Immunotoxicity & immune profiling

Characterize local immune responses with cytokine profiling, RNA sequencing, spatial biology, and flow cytometry.

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Dermatology drug development

Anti-inflammatory drug testing, psoriasis and atopic dermatitis pathway analysis, barrier function, and wound repair studies.

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Local tolerance & tissue safety

Evaluate local inflammatory markers, tissue viability, and formulation effects — before committing to GLP toxicology studies.

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Skin delivery & formulation optimization

Investigate skin penetration, tissue exposure, and formulation impact to optimize your route and candidate before downstream studies.

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Vaccine development

Characterize immune response at the injection site using multiplex cytokine profiling and AUDACY bioinformatics — validated with mRNA vaccines.

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Skin models for drug development

Order ready-to-use models for in-house studies, or work with our CRO team for custom study designs.

HypoSkin®

The only ex vivo model including the hypodermis — where subcutaneous injections occur. Native immune cells fully intact. Best for:

  • SC & ID injectables
  • ISR prediction
  • Biologics

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NativeSkin®

Full-thickness human skin — epidermis, dermis, and appendages — alive for 7 days. The standard for topical and transdermal studies. Best for:

  • Topical & transdermal
  • Skin penetration
  • Dermatology

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Human Primary Mast Cells

Ready-to-use human primary mast cells for allergy, anaphylaxis, and drug hypersensitivity research. Ships with full protocols. Best for:

  • Drug hypersensitivity
  • Anaphylaxis
  • Immunology

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Frequently asked questions

What are NAMs?

NAMs, or New Approach Methodologies, are innovative research approaches designed to improve the human relevance of preclinical testing and reduce reliance on traditional animal models. Genoskin’s living human ex vivo skin models are NAMs that allow researchers to study drug, formulation, immune, and tissue responses directly in human skin.

How can Genoskin support research before GLP studies?

Genoskin can help pharma and biotech teams generate early human-relevant data before committing to more costly GLP studies. These studies can support candidate selection, formulation optimization, route-of-administration decisions, biomarker identification, immunotoxicity assessment, and local tolerability evaluation.

Are Genoskin studies GLP studies?

Genoskin studies are best positioned as early, human-relevant preclinical NAM studies that complement standard non-GLP, GLP, and regulatory programs. They can help teams refine development decisions before investing in more resource-intensive GLP testing.

Can Genoskin data help reduce development risk?

Yes. By providing human ex vivo data earlier in development, Genoskin can help teams identify potential local tolerability, inflammatory, immunological, formulation-related, or delivery-related concerns before advancing to later-stage preclinical or GLP studies.

What types of therapeutics can be tested?

Genoskin can support studies involving biologics, monoclonal antibodies, vaccines, peptides, oligonucleotides, small molecules, topical dermatology drugs, transdermal systems, injectable therapeutics, and devices or products that interact with human skin.

Can Genoskin help assess injection-site reactions?

Yes. Genoskin’s hypodermis-containing models can support studies of local responses following intradermal or subcutaneous administration, including tissue integrity, cytokine release, immune activation, local tolerance, and donor-dependent variability.

What readouts are available?

Depending on the study design, readouts may include histology, tissue viability, immunostaining, cytokine and chemokine profiling, RNA sequencing, single-cell RNA sequencing, flow cytometry, spatial biology, analytical chemistry, and customized biomarker panels.

Can studies be customized?

Yes. Study design can be adapted based on the compound, modality, formulation, route of administration, model type, donor strategy, treatment duration, and endpoints required.

How does Genoskin complement animal studies?

Genoskin provides human ex vivo NAM data that can complement animal studies by adding tissue-level information from human skin. This can be especially valuable for questions involving local tolerance, immune response, inflammation, injection-site reactions, and human-specific skin biology.

When should we use Genoskin in our development program?

Genoskin is particularly useful when you need human-relevant data before major development decisions, including candidate prioritization, formulation selection, route optimization, biomarker planning, local tolerance assessment, or preparation for GLP studies.