Biomere has partnered with Emulate to offer early toxicology CRO services using the Zoe Organ-Chip system, a NAMs platform nearing full qualification as an FDA Drug Development Tool (DDT). The platform allows toxicity assessment of novel therapies before moving to time-consuming and costly in vivo studies. It also supports the 3Rs, with the potential to reduce and refine animal use.
The Organ-Chip platform supports the culture of multiple cell types from specific organs, including the liver, kidney, lungs and brain. Cells are cultured in a microfluidics-controlled system that flows media across two channels separated by a membrane, allowing different cell types to be cultured in each channel and interact with each other.
In the Liver-Chip primary human hepatocytes are cultured on the top channel, with non-parenchymal cells (Kupffer cells, stellate cells, and liver sinusoidal endothelial cells, or LSECs) on the bottom. This combination of tissue-specific cells and continuous media flow mimics the in vivo state, supporting physiologically relevant responses to therapies.
Biomere offers preclinical drug discovery services using the Organ-Chip system. The first validated application is evaluation of drug-induced liver injury (DILI), a key component of drug safety studies. Subsequent services will include kidney toxicity assessment using the Kidney-Chip and neurotoxicity assessment using the Brain-Chip.
Figure 1: Emulate’s Organ-Chip system includes the Orb, the Zoe-CM2, and pods that hold the chips. Each Zoe culture module holds 12 chips (one per pod), and the Orb module connects to lab equipment to monitor gas, power, and other parameters.
The primary endpoints for the Organ-Chip system include:
The Biomere team is excited to collaborate with drug developers to evaluate new Organ-Chip models and services.
Biomere scientists have performed pilot studies to evaluate the Organ-Chip platform using available medications reported to cause liver injury clinically.
LPS-Induced Toxicity:
Acetaminophen Toxicity:
Clozapine-Induced Toxicity:
These examples highlight the protocols and key endpoints used to measure liver toxicity induced by known or novel therapies in a physiologically relevant human Organ-Chip system.
