Organ-on-a-chip technology could accelerate BioE3’s goal of personalizing medicine

On August 24, the Indian government announced the “BioE3” policy to drive innovation in the biotechnology sector by setting up bio-manufacturing facilities, bio-AI centres and bio-foundries. (“AI” stands for artificial intelligence). A key focus of the policy is precision therapy, which involves developing and delivering drugs according to the needs of individual patients. The policy also aims to boost the development of biologics such as gene therapy and cell therapy.

Recent advances in human-relevant 3D culture models, also known as “new approach methods” (NAM), have shown promising results in the field of precision therapy. These models include 3D spheroids, organoids, bioprinting, and organs-on-chips.

The global organ-on-a-chip market is expected to be worth around $1.4 billion by 2032. This expansion is the result of increasing investment in research and development in the NAM field, particularly in organ-on-a-chip technology. Since its invention, this technology has gained significant momentum and is poised to revolutionize the healthcare sector by integrating cells derived from the human body with well-defined in vitro a biological environment (e.g. in a laboratory) that mimics the conditions prevailing in the body.

The main factor driving the organ-on-chip market is the growing demand to replace animal drug testing.

In April, a British company called CN Bio raised $21 million from venture capitalists to expand its R&D efforts in organ-on-chip technology. In the U.S., Vivodyne raised $38 million in seed funding to integrate large-scale automation and artificial intelligence into organ-on-chip technology. These are just two recent examples of the growing interest in the technology and its commercial value.

Drug Testing and Development

In the current and traditional drug development process, it takes scientists nearly a decade and an average cost of $2.3 billion to bring a new drug from the lab to the market. But many drug candidates also fail in the final stages of clinical trials. One major reason is that in early stages, these drugs are tested in animal models—animals genetically engineered to respond to the drug in the same way a human organ (or organs) would. Drugs that work in these animals often fail in humans.

Organ-on-chip technology offers a potential solution to this problem by providing a more accurate and efficient platform for testing drugs without involving animals or humans in preclinical testing. Organ-on-chip is a small device designed to replicate the dynamic functions of certain human organs in a controlled microenvironment. They are expected to be superior to the cell cultures and animal models that scientists currently use to test drug effects. The results obtained using these devices will in turn provide a better understanding of the efficacy and toxicity of drug candidates, reduce the use of animals and pave the way for personalized treatments.

The technology could also reduce the time and cost of developing drugs, allowing for faster time to market and potentially lower prices.

Investments in technology

Scientists first reported the usefulness of the organ-on-chip model in a 2010 study. Two years later, the U.S. National Institutes of Health allocated $100 million in funding for researchers to develop specific organ-on-chip devices, including for the kidney, intestine and heart, as well as body-on-chip devices that could simulate the effects of a drug on multiple organs simultaneously.

The potential of the technology for drug development has quickly become clear, and as a result, there are many organ-on-chip companies in the world that are currently focused on developing microphysiological systems for various organs. In addition to those mentioned above, there are currently chips that mimic the liver and lungs.

The US government further strengthened the field by passing the FDA Modernisation Act 2.0 in September 2022. The act allows researchers to develop, use and qualify organs-on-chips as an appropriate alternative wherever possible, including for testing drugs in preclinical stages of drug development. A year earlier, members of the European Union decided to phase out animal testing for cosmetics. The bloc is currently working on a regulatory framework for the use of NAMs, including organs-on-chips.

Many international pharmaceutical companies are also testing the waters. Bayer, for example, is working with TissUse on a liver and multiple organ-on-a-chip model. Roche is using chips developed by Mimetas to study the effects of inflammatory bowel disease and hepatitis B virus infections. AstraZeneca and Johnson & Johnson are using several chips made by Emulate Bio for their biological studies. By one recent estimate, at least 30 pharmaceutical companies worldwide are evaluating organ-on-a-chip models to move away from animal testing.

Challenges for India

India has also taken a step in this direction by amending the New Drugs and Clinical Trials Regulations, 2019, to allow the use of human organs-on-chips and other NAMs before and in connection with animal testing during the evaluation of new drugs. In July this year, the CSIR-Centre for Cellular and Molecular Biology, Hyderabad, and the Central Drugs Standard Control Organisation organised a workshop on the latest scientific and regulatory developments in the field of NAMs.

Developing organ-on-chip technology requires collaboration between experts from various fields—bioengineering, pharmacology, biotechnology, computer science, and clinical medicine. Currently, more than 80 labs are working on NAM, including developing 3D culture models for various applications. To fully realize the potential of this technology, India needs to set up dedicated centers that will facilitate such collaboration.

Secondly, the presence of such centres will help in communication between industry and academia. In particular, personalised medicine requires that NAMs take into account the genetic differences between the Indian populations for which the NAM is being tailored and the populations on which the drug or therapy has already been tested.

Third, researchers will have to deal with regulators and their requirements and navigate the regulatory framework for developing, standardizing, and qualifying organ-on-chip devices. The centers could streamline this process and ensure that chips go from the lab to the production floor without any glitches.

Because these centers will house a dedicated and skilled team of researchers, they can also build a new skill base for the next generation of scientists and engineers and help ensure a steady flow of talent to drive the development of organ-on-a-chip technologies. The centers could even create opportunities for an industry-linked doctoral program to help graduates and postgraduates move seamlessly between academia, research, and industry after completing their education.

As medical research advances rapidly, it is important for the Indian government, the business and investment community, and policymakers and regulators to facilitate the establishment of organ-on-chip centres that will improve the healthcare system while also boosting the economy. By supporting these technologies and centres, India could also increase its self-sufficiency in an area of ​​developmental and strategic importance.

Manjeera Gowravaram has a PhD in RNA biochemistry and is a freelance science writer. Viraj Mehta has a PhD in biomedical engineering and supports pharmaceutical companies and CROs in developing NAM or microphysiological assay-based systems for drug discovery and development.