Science and labs
Organoids and NAMs
Organoids are tiny 3D tissues grown from human cells. We use them to test whether a product is safe and whether it works, before larger studies. We deliver this work in collaboration with Tissue Zen.
What it is
In one sentence
We test products on small pieces of human tissue grown in the lab, to get early safety and efficacy data from human cells.
Who it is for
Research and development teams at pharma, biotech, cosmetic and nutraceutical companies. Also university and hospital teams working on new treatments or on precision medicine (treatment matched to each patient).
Problems it solves
Why test on human cells
Animal results do not always carry over
Animal bodies are not the same as human bodies. Testing on human cells can add human data early, and can help reduce some animal testing.
Flat cell cultures miss the full picture
Cells grown in a flat layer do not behave like real tissue. Organoids grow in 3D, so they are closer to how tissue behaves in the body.
Big decisions with little data
A small proof-of-concept study gives an early answer before you spend on a large programme. Proof of concept means a first test of whether an idea works.
What you get
Deliverables
- Patient-derived organoid models, grown from a patient's own cells
- Skin, breast and patient-derived tumour organoid panels
- Custom groups of patient samples for your question
- Toxicology panels, which test whether a product harms cells
- Efficacy panels, which test whether a product has the effect you want
- Drug repurposing screens, which test medicines already in use against a new disease
- Translational validation studies, which check that lab results point the right way for patients
- Support for precision medicine studies
- A study report set out so NAM data can be used in a regulatory filing
How it works
How a study runs
A screening panel typically takes 4 to 8 weeks. It depends on the model, what we measure and how many repeats we run. A proof-of-concept study can take about 3 weeks.
Define the question
We agree what you want to learn, which tissue model to use, and what to measure.
Design the study
We set the doses, the controls, the number of repeats and the readouts (what we measure, such as whether the cells live).
Grow the organoids and run the tests
We grow the organoids, treat them with your product and record the results.
Analyse and report
We analyse the results and explain what they mean for your next step. You get a full study report.
Regulators and standards
Guidance we work with
How regulators use NAM data is still changing. We check the current position for your product and market before the study starts.
- OECD Guidance Document 286
- The OECD's guidance on good practice for lab tests on cells, called Good In Vitro Method Practices.
- ICH S5(R3)
- The international guideline on testing medicines for effects on having children. It allows some tests that do not use animals, in set cases.
- Terms explained
- An organoid is a tiny 3D tissue grown from human cells. A NAM (new approach method) is a way to test that can reduce animal testing, such as organoids. IATA (Integrated Approach to Testing and Assessment) is a way of weighing results from several kinds of test together. Toxicology is the study of harm. Efficacy means whether a product works. In vitro means in the lab, outside a living body.
In collaboration with Tissue Zen
About Tissue Zen
Tissue Zen is a separate company and our collaborator. It grows the organoids and runs the lab work for this service.
Who does what
- Tissue Zen grows the organoid models, runs the tests and reports the results.
- TrialGuna helps you plan the study, and then use the results in the rest of your work: lab tests, clinical trials and regulatory filings.
- You deal with one team from start to end.
The team
A core team of 5 scientists and technologists, with PhDs in cell biology, developmental biology and bioengineering.
Models
Skin, breast and patient-derived tumour organoids. Patient-derived means grown from a patient's own tumour cells.
FAQs
Questions we are often asked
What is an organoid?
A tiny 3D tissue grown in the lab from human cells. It is not a full organ. But it copies some of the structure and behaviour of real tissue, so it can show how human tissue might react to a product.
What is a NAM?
NAM stands for new approach method. It is a way to test safety or efficacy that can reduce animal testing. Organoids are one kind of NAM. Others include computer models and tests on cells.
Will regulators accept organoid data?
It depends on the regulator, the question and how the study is run and reported. Some regulators now consider NAM data alongside other evidence, often as part of an IATA. US FDA and WHO guidance now discuss data from methods like these. Organoid data rarely replaces all other tests. Talk to us and your regulator early about how the data will be used.
Which organoid models do you offer?
Skin, breast and patient-derived tumour organoids. We can also build custom groups of patient samples for your question.
How long does a screening panel take?
Typically 4 to 8 weeks. It depends on the model, what we measure and how many repeats we run. A proof-of-concept study can take about 3 weeks.
Do you run drug repurposing screens?
Yes. We test selected sets of medicines already in use against a new disease model. We measure the results in more than one way: whether the cells live, what they look like under a microscope, and which genes they switch on.
Can organoids replace animal studies?
Not in every case. Organoids can answer some questions early, using human cells. They can help reduce animal testing. But many products still need other studies before approval. We help you decide where organoid data fits.
These answers are general information, not advice for your product. Rules change. Check the latest guidance, or ask our team about your product.
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Often used together
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Start a conversation
Talk to us about human-cell testing.
Tell us about your product and the question you need answered. We will suggest an organoid model and a study plan.