The NAMs ecosystem encompasses a broad spectrum of technologies, from cell culture-based approaches, bioengineering to computational modelling.

To better predict clinical outcomes, new approach methodologies are the space of integration of advanced cell culture systems with material engineering to simulate specific organ functions and tissue mechanics. The ioCells portfolio enables precise interrogation of disease mechanisms, CRISPR genomic and toxicity screenings, providing a platform for building powerful NAMs for tomorrow's medicines.

In a landmark decision, the FDA announced a plan to phase out animal testing requirements for monoclonal antibodies and new drugs. This move encourages the adoption of New Approach Methodologies (NAMs) to improve drug safety and efficiency, marking a pivotal moment for human-relevant science.

The FDA’s decision marks the dawn of a new era. By accepting proven alternatives to animal models, drug developers can now move toward safer, faster, and more ethical clinical trials without routine animal experimentation.

In this exclusive ISSCR presentation, Prof. Marius Wernig and Dr Mark Kotter discuss the evolution of cellular reprogramming from a biological paradigm to an industrial reality. Wernig outlines the foundational science of transcription factor-mediated cell identity, while Kotter explains how integrating this biology with opti-ox technology overcomes the variability of traditional methods. This approach enables the scalable, precise manufacturing of human cells needed to unlock the full potential of regenerative medicine.

Immunocytochemistry staining of a tri-culture with ioGlutamatergic Neurons, ioAstrocytes and ioMicroglia. Cell cultures stained for MAP2 (neuron marker), Vimentin (astrocyte marker), and IBA1 (microglia marker), validating the integration of all three cell types.

Co-culturing multiple cell types allows researchers to mimic natural cell-to-cell and neuron-glial interactions. This tri-culture system provides a validated physiologically-relevant model to replicate neuroinflammatory and neurodegenerative pathways that isolated monocultures may miss.

Automated generation of human neuronal microtissues. ioGlutamatergic Neurons and iPSC-derived astrocytes were bioprinted using the Inventia RASTRUM™ platform to form 3D co-cultures in a CNS-mimetic hydrogel. The model supports high-throughput screening in 96- and 384-well formats, exhibiting mature phenotypes and extensive neurite outgrowth. Data courtesy of Inventia Life Science.

Printoids are 3D tissues engineered via bioprinting, where cells are deposited in precise, orderly spatial arrangements. Unlike self-assembling models, printoids allow for the standardised reconstruction of complex tissue interfaces. ioCells enable the generation of reproducible neuronal microtissues at scale.

Developing advanced neuromuscular cultures. Dr Grace Cooper showcases a 28-day co-culture of ioMotor Neurons and ioSkeletal Myocytes. In this talk, she explores the development of physiologically relevant interactions in the NETRI DuaLink microfluidic system, creating an MEA-compatible model for studying synaptic development.

Organ-on-chip, or Microphysiological Systems (MPS), engineer physiology through geometry and flow. Cells are cultured in compartmentalised microfluidic devices to mimic tissue mechanics. These new approach methodologies model systemic interactions, such as long-range nerve signalling and axonal transport, that static plates cannot capture.

With a defined input and an advanced architecture (NAMs), it is possible to generate a reliable, reproducible output to transform NAMs from experimental concepts to into robust industrial tools for drug discovery and toxicity testing.  

Download the poster to see how ioCells are being incorporated into a variety of NAMs to support the transition to human-specific research.