MakbySafety
Investigate tissue injury, barrier disruption and inflammatory responses.
Chapter B / Next-generation preclinical NAMsAdd the human dimension
Add the human dimension
before the clinic.
Human-relevant tissue models and tailored testing services for safety, efficacy, ADME and translational studies.
Discuss your study01 / Begin with the question
What do you need
to understand?
Choose the model and endpoints around the development question.
Efficacy
Explore tissue-specific responses, treatment effects and dose–response relationships.
ADME & delivery
Characterize transport, permeability, tissue exposure and metabolism where supported.
Mechanisms
Connect exposure and biological response through relevant functional endpoints.
02 / Ways to work together
Your question.
Our capabilities.
Preclinical testing services
Work with MAKBY on a study designed around your candidate, development question and required endpoints.
Ready-to-use tissue models
Integrate available human-relevant tissue systems into your in-house experimental workflows.
Custom NAM development
Engineer indication-, mechanism- or endpoint-specific models when standard systems do not fit your question.
Co-development partnerships
Combine model design, biomaterials, bioprinting and characterization in a collaborative development program.
03 / Omnicell tissue atlas
Find the human
dimension you need.
Explore tissue systems and representative endpoints. Model configurations are selected to fit the study.
Skin
Investigate formulation performance, tissue exposure and skin safety in human-relevant tissue systems.
Model systems
- Epidermal and full-thickness skin
- Fully synthetic matrix skin
- Human iPSC-derived skin organoids
Representative endpoints
- Barrier integrity and TEER
- Penetration, flux and tissue distribution
- Viability, histopathology and inflammatory responses
Portfolio summarized from MAKBY’s September 2026 flyer. Availability and suitability depend on the project and chosen configuration.
04 / From candidate to evidence
Four steps.
One focused study.
Define
Clarify the candidate, indication and decision the study should inform.
Select or engineer
Match the tissue model, cellular composition and complexity to the question.
Test
Generate data using relevant exposure conditions and endpoints.
Interpret
Review the evidence in the context of model capabilities and study objectives.
05 / A stronger weight of evidence
Make the model
fit the question.
Human-relevant NAMs can complement conventional preclinical evidence. We discuss tissue architecture, biological function, characterization and study-specific limitations when developing the approach.
Read the NAMs catalogueWhat does NAM mean?
New Approach Methodologies: approaches that can contribute human-relevant evidence and reduce reliance on conventional animal-based testing.
Can models be customized?
The portfolio includes custom development around indications, mechanisms and endpoints, as well as multicellular configurations selected for the project.
Can we run studies in our own laboratory?
MAKBY offers ready-to-use tissue models for in-house workflows alongside testing services. Discuss model availability and experimental requirements with the team.
What should your next study reveal?
Tell us about your candidate, tissue and development question.