Engineered brain organoids: 13x more predictive of human clinical outcomes.

Detect critical CNS risks before the clinic while preserving safe drugs.
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A Complex in vitro Model of the human brain

3D Brain Organoids
CNS-3D Brain Organoids are human brain microtissues derived from induced pluripotent stem cells (iPSCs) differentiated into neural progenitor cells (NPCs). The resulting cortical organoids mature to 500–600 µm in diameter, exhibit spontaneous, electrically driven network activity, and display transcriptomic profiles consistent with human cortical tissue.
Cell Types
Each CNS-3D Brain Organoid contains a balanced mix of neurons (~50%) and astrocytes (~50%), along with small population of progenitor cells. Within the neuronal population, ~90% are glutamatergic (excitatory) and ~10% are GABAergic (inhibitory). This cellular composition is highly consistent across batches, ensuring stable excitatory/inhibitory balance, metabolic support, and consistent functional outcomes.
Cell Types Biology Diagram
Reproducibility
CNS-3D Brain Organoids deliver consistent results across experiments, production batches, and time. Each brain organoid displays highly consistent size, cell composition, and functional response, enabling reproducible results from the first experiment onward. Performance is stable across a validated, 4-week assay window, supporting longitudinal (weeks-long) treatment paradigms.
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Quality Control
Every batch of CNS-3D Brain Organoids is produced and tested under a rigorous quality control framework to support consistent biological performance. Each shipment includes a Certificate of Analysis verifying organoid size (<5% VC, 98% presence), neuron-to-astrocyte ratios, sterility (mycoplasma, bacterial, fungal), and functional assay performance for 8 reference compounds (EC/IC₅₀ and robust Z’ values for FLIPR screening).
Quality Control Graph 01
Assays
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FLIPR Functional Modulation
CNS-3D Brain Organoids exhibit spontaneous functional activity quantifiable viahigh-throughput FLIPR using a calcium-sensitive fluorophore. Consistent waveform profiles across replicates enable reliable neurotoxicity and neuromodulation screening with as few as four replicates per condition.
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Cell Viability Assessment
Cell viability assays such as CellTiter-Glo and LDH-Glo can be run alone or multiplexed with FLIPR to distinguish between neuromodulatory and cytotoxic effects.
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3D High-content Imaging
High-resolution imaging and custom analysis algorithms enable precise quantification of treatment-induced morphological changes in specific brain cell types at cellular and subcellular levels.
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Multiplexed Sample Collection
Post-treatment CNS-3D Brain Organoids and media can be frozen to preserve RNA, proteins, and secreted factors for downstream analyses, including transcriptomics, proteomics, and ELISA-based biomarker assays.
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Additional Assays
CNS-3D Brain Organoids support a wide range of standard fluorescence, luminescence, and colorimetric assays, including JC-10 (mitochondrial health), Live/Dead imaging, cytokine profiling, and enzymatic activity (e.g., AChE).
Use Case

Neurotoxicity

Predict neurotoxicity risk with higher confidence ahead of in vivo studies. CNS-3D Brain Organoids achieve 83% sensitivity and 89% specificity in predicting clinical seizure liability for small molecules, and 92% sensitivity and 92% specificity for ASOs.

By measuring functional disruption of neuronal network activity, CNS-3D enables confident identification of neurotoxic liabilities while minimizing false positives, outperforming both animal models and 2D co-cultures.
Sensitivity and specificity comparison for small molecule seizure risk prediction, demonstrating improved performance of CNS-3D versusalternative models.
Use Case

Gene Therapy

Prioritize AAV vectors earlier using functional, human data. CNS-3D Brain Organoids integrate assessment of transduction efficiency, toxicity, and functional impact in a single model. This approach resolves serotype- and promoter-dependent differences in vector performance and detects disruption of neuronal network activity before overt viability loss
Representative images ofAAV transduction in CNS-3D Brain Organoids, demonstrating clear serotype- andpromoter-dependent GFP expression.
Use Case

Disease Modeling

Investigate mechanisms of neurological disease and assess drug efficacy with human biology. CNS-3D Brain Organoids support flexible disease modeling approaches, including patient-derived, CRISPR-engineered, and induced models across a range of diseases, including Rett syndrome, CDKL5 deficiency disorder (CDD), and demyelinating disease. High-throughput functional screening enables identification of compounds that restore neural function without toxicity, supporting rapid prioritization of therapeutic candidates.
Disease Modeling Diagram 01
CNS-3D Brain Organoids modeling two distinct neurodevelopmental disorders Rett Syndrome (orange) and CDKL5 Deficiency Disorder (teal) display unique functional phenotypes and can be grown in 384-well plate formats.
Use Case

Demyelinating Disease

Evaluate therapeutic efficacy in demyelinating diseases such as multiple sclerosis with the only 3D cell model that incorporates cortical neurons, astrocytes, and oligodendrocytes. CNS-3D Myelinated Organoids enable quantification of myelin loss, natural recovery, and therapeutic remyelination for human-relevant evaluation of remyelinating therapies and demyelination risk.
Representative image of CNS-3D Myelinated Organoid at 12 weeks, showing neurons (NFH, magenta) and myelinating oligodendrocytes (MBP, green).

Products & Services

CNS-3D Brain Organoids
Assay-ready neural organoids available in 24-, 48-, 96-, and 384-replicate formats.
CNS-3D Standard Services
Turnkey neurotoxicity and drug screening studies at high-throughput—no in-house expertise required.
CNS-3D Custom Services
Tailored 3D neural models incorporating microglia or oligodendrocytes, for neuroinflammation or myelination studies.

CNS-3D Brain Organoid Resources

Will it work in humans?

28bio helps you answer that critical question before the first patient is dosed. Contact us to assess your translational risk.