An expert from CN Bio explains
At the core of the FDA Modernization Act 2.0 (2022) was the acceptance of data derived using New Approach Methodologies (NAMs), like AI, in-silico tools and Organ-on-a-chip, into regulatory filings. At the core of their subsequent roadmap to reduce animal testing in 2025 is an actionable phased strategy to reduce, refine, and ultimately phase out routine preclinical safety testing in animal studies in favor of a NAMs-based approach by encouraging and incentivising their use.
Since then, funding initiatives across the US and Europe have arisen to build research facilities, set up universal standards, train, develop and accelerate the adoption of Organ-on-a-chip (OOC) technology – also known as microphysiological systems (MPS).
Companies that have embraced OOC technology have the early advantage. They utilise it to improve the efficiency of their workflows by addressing gaps where traditional in-vitro assays are not physiologically relevant enough, but animal use is less suited owing to inherent interspecies differences. Some have widely adopted the approach, others have dabbled, many are yet to get started. But there’s no doubt that the field is gaining momentum!
There are many OOC technologies available
If you ask AI what is at the core of Organ-on-a-chip (OOC) technology, it lists “microfluidics to perfuse cultures, 3D cell culture, dynamic mechanical cues and the integration of multiple cell types, enabling users to create lab-grown mimics of human organs and tissues that behave and respond to drugs, toxins, or disease in a way that is more physiologically relevant than traditional 2D cell culture or many animal models”.
While this is true, there are many OOC technologies available and each is different. When the time’s right to modernise your workflows with OOC, it is important to match each system’s core strengths to your needs before choosing. Incorporating any new approach into your workflow takes time, so choose a solution whose core design prioritises ease of setup and use, helping you onboard quickly and sustain momentum.
Criteria to consider before committing
Remember, the purpose of OOC is to enhance physiological relevance but OOC systems themselves don’t have to be prohibitively complex, they can be plate-based and familiar and utilise commonly used consumables such as Transwells. So, before you commit, consider the following key criteria:
- Make sure that you are comfortable handling the consumables for assay setup and sample extraction.
- Ensure that the system is easy to program. Don’t waste valuable time over maintenance routines.
- More importantly, make sure you have adequate training and support to get on the right path. New researchers typically need 5–6 weeks to confidently run PhysioMimix Core experiments.
Deborah Lenart, MSc, Charles River, said: ‘Using the PhysioMimix OOC System is really straightforward; with a little practice, any tissue culture scientist can master the skills needed.’
Access to highly characterised and validated assays is key to your initial success. Most vendors provide validated all-in-one assay or model kits, or protocols that enable new users to get to grips with OOC basics fast but rarely does one size fit all. Therefore, to meet one’s immediate and future needs, another core element to consider is a system’s adaptability.
Futureproofing also relates to scalability and the cost of OOC experiments. Consider the throughput you will require once OOC becomes embedded as a core technology and ensure this can be met. Explore the cost per chip and options for cost reduction via miniaturisation without compromising data integrity. Ensure you can extract the widest range of endpoint analysis from each experiment to maximise value and remember, the benefits of perfused organ or tissue cultures can also be applied to more cost-effective cell types, such as iPSCs.
So, what are you waiting for? To enhance preclinical efficiency, physiologically relevant OOC models and assays represent the future, enabling you to gain deeper and more human-relevant insights into drug responses to inform decisions about which candidates to take forward. To future-proof your investment, ensure you have a strong foundation. Look for an intuitive core system that will grow with your research needs so that you can adopt, adapt and scale with ease.
For more information visit: www.cn-bio.com
How customers benefit from the product’s open architecture:
Examples of how PhysoMimix customers have benefitted from its open architecture:
- In a recent webinar, BMS described their work incorporating endothelial cells into a Drug-induced liver injury (DILI) assay, whilst scientists at Sanofi have presented their development of a fully immunocompetent DILI assay at conferences.
- Others have applied existing Liver-on-a-chip models to a different context of use (e.g. antisense oligonucleotide delivery at GSK (1), progressive human hepatic resistance MIT & Novo Nordisk collaboration (2).
- Charles River utilised CN Bio’s core technology to design their own genotoxicity model and assay (3).
- Roche initially utilised a single-organ liver model for quantitative drug metabolism studies (4) before progressing to a dual-organ gut/liver model to simulate the process of first pass metabolism in vitro (5).
1. DOI: 10.1039/D4LC00504J
2. DOI: 10.1101/2025.01.08.631261
3. https://doi.org/10.1016/j.mrgentox.2024.503762
4. https://doi.org/10.1039/D1LC01161H
5. DOI: 10.1039/D2LC00276K
