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 New Approach Methodology (NAM) data earlier in development.

By integrating Genoskin preclinical evaluations before more costly GLP or clinical 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 to subcutaneous and intradermal biologics in real, immunocompetent human skin.

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Immunotoxicity & immune profiling

Characterize local immune responses with multiplex cytokine profiling, transcriptomic analysis, 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 healing 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 transcriptomic analysis validated with mRNA vaccines.

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Skin models and human primary mast cells 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 human skin model incorporating the hypodermis, enabling physiologically relevant assessment of subcutaneous injections while maintaining fully intact native immune cells. Best suited for:

  • Subcutaneous & intradermal injectables
  • ISR prediction
  • Biologics testing

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NativeSkin®

Viable full-thickness human skin comprising the epidermis, dermis, and native skin appendages, preserved ex vivo for up to 10 days. Ideal for evaluating topical and transdermal interventions in a physiologically relevant human model. Suitable for:

  • Topical & transdermal applications
  • Skin penetration assessment
  • Dermatology research

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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
  • Allergy research
  • Mast cells targeting

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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 non-clinical and 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 reactions to tested compounds, and tissue responses directly in human ex vivo skin.

How can Genoskin support research before clinical studies?

Genoskin can help pharma and biotech teams generate early human-relevant data before committing to more costly clinical 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 not 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, clinical 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, transcriptomic analysis, 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.