Contribute Try STAT+ Today

Human biologic drugs, including cancer-fighting antibodies, vaccines, or gene therapy targets, currently make up more than 40 percent of drug development pipelines. Biologics are designed to interact specifically with human cellular pathways and proteins, and successes in the past five years have significantly increased the demand for more. Biologic drugs have captured mainstream attention and pharmaceutical interest with mRNA-based vaccines for Covid-19, immunotherapies like pembrolizumab for certain cancers, and immune suppressors for rheumatoid arthritis and Crohn’s disease.

And yet the current drug discovery and development process remains crowded, expensive, and slow. Nearly 90 percent of drug candidates fail to reach the market. Often these failures occur in human trials, suggesting that traditional models for efficacy and safety testing are insufficient for biologic drugs. These dismal realities are prompting many to question what can be done to help pharmaceutical companies ensure biologic drugs in the pipeline will work more predictably in humans.

One of the barriers to improving the drug development process is continued reliance on in vitro cell culture and animal testing models in pre-clinical research. Cell culture technology has been historically slow to innovate. Advances in stem cell propagation and two-dimensional culture methods provide more accurate models than static cell lines in a petri dish, but lack three-dimensional context, cellular microenvironment, and multi‐organ physiology, decreasing the predictive value of in vitro studies.

The majority of animal studies are carried out in rodents that do not replicate human biology and are usually not effective in predicting drug response. Species differences can account for some animal model missteps but even increasing the use of non-human primates has not mitigated the high failure rates in clinical trials, skyrocketing development costs, and longer waits for drug approvals.

As a growing percentage of products in the pharmaceutical market leverage human biology for their function, the need for a more integrated and human-relevant approach to drug discovery and development becomes critically important.

Despite the lack of predictive models for drug development, organ-chips are bridging the gap between in vitro and in vivo, expanding beyond traditional cell culture methods and reducing the reliance on animal models in drug development. Organ-chips are in vitro models built using primary, patient‐derived or differentiated human cells. The dynamic chip that houses the cells incorporates microfluidics to mimic vascular perfusion as well as membranes that function as tissue–tissue interfaces. It can accommodate other important mechanical forces such as stretch to simulate breathing or intestinal peristalsis. Emulate’s Human Emulation System, which includes organ-chips, hardware, and software, meets a critical need of pharmaceutical companies seeking better ways of testing and developing drugs, especially biologics.

Organ-chips are poised to set a new standard for better predicting how humans respond to drugs than cell culture or animal-based methods. Emulate organ-chip solutions will help pharmaceutical companies shorten drug development time, increase their likelihood of success, and significantly decrease costs.

The Human Emulation System’s broad range of organ models including the Brain-Chip, Liver-Chip, Intestine-Chip, Lung-Chip, and Kidney-Chip, are being utilized for different stages of the drug discovery and development process, including target identification and validation, mechanistic studies, drug delivery and biomarker identification, ADME and toxicity. Learn more today.