BIOTECHNOLOGY
The core of innovation An expert from CN Bio explains how preclinical testing is transformed with Organ-on-a-chip technology
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t 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-ona-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 NAMsbased 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
CN Bio’s PhysioMimix Core microphysiological system mimics human physiology
Recombinant Human B7-H3 Protein (ECD, His Tag), Endotoxin-Free Cat#: 11188-H08H-UE
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 labgrown 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
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