In Context
- The FDA Modernization Act 2.0, signed by President Biden, allows clinical trial leaders to use animal trial alternatives instead of traditional animal modelling for drug and biological development.
- The move is expected to boost the research and development of organ chips.
What are Organ-on-a-Chips?
- Organ-on-a-Chips refers to a micro-engineered biomimetic system that reflects the structural and functional characteristics of human tissue.
- It is also known as micro physiological systems or “tissue chips”.
- It is small devices containing human cells that are used to mimic the environment in human organs, including blood flow and breathing movements, serving as synthetic environments in which to test new drugs.
- It involves biomaterial technology, cell biology, and engineering combined together in a miniaturized platform.
Applications
- It has attracted substantial interest in recent years due to its numerous applications, especially in precision medicine, drug development, and screening.
- It can replicate key aspects of human physiology, providing insights into the studied organ function and disease pathophysiology.
- Moreover, these can accurately be used in drug discovery for personalized medicine.
Importance
- Organ-on-chip (OoC) is a concept of great interest all around the globe, due to the importance of its applications in the biomedical field.
- It is very important for drug development and the effects that they have on different organs.
- Drugs are mostly tested on animals, which in some cases give inaccurate data or raise ethical concerns from organizations such as People for the Ethical Treatment of Animals (PETA)
- This led to researchers searching for new ways to allow testing on human cells.
- These devices present useful substitutes for traditional preclinical cell culture methods and can reduce the use of in vivo animal studies.
- They are free from ethical issues associated with [the use of] animal models.
Developments
- Across the Globe: Donald E. Ingber, a professor of bioengineering and director of the Wyss Institute at Harvard University, and his colleagues developed the first human organ-on-chip model in 2010.
- It was a ‘lung on a chip’ that mimicked biochemical aspects of the lung and its breathing motions. Ingber’s group went on to develop more human organs-on-chips.
- In 2014, members of Wyss Institute launched a start-up called Emulate Inc. to commercialize their technology.
- The group has since created several different chips, including the bone marrow, epithelial barrier, lung, gut, kidney, and vagina.
- Scientists also formed consortia to encourage research in this field, such as the European Organ-on-Chip Society.
- Organs on a chip in India: Researchers in India are also developing organ-on-a-chip models, including a skin-on-chip model, which is being tested for studying skin irritation and toxicity, and a retina-on-chip model.
Issues and Challenges
- India’s regulators lack exposure to researchers’ issues while academicians don’t fully understand regulatory requirements.
- There are bureaucratic hurdles as well. Examples of the “inflexible heads of expenditures in government grants” and the delay in releasing money for sanctioned grants.
- There is still a reluctance on the part of the industries in [using this] for preclinical research due to the lack of experienced personnel”.
Conclusion and Suggestions
- The researchers hope to see larger consortia with diverse experts from academia, industries, and regulators come together to be able to compare India’s organ-on-chip efforts with those of the West.
- There is a need for multidisciplinary knowledge from the biomedical and engineering fields to understand and realize OoCs.
Source:TH
