How Is India Establishing Its 3D Bio Printing Industry?
By March 2023, researchers have been allowed to adopt other methods to assess the safety and efficacy of new drugs since India amended its 2019 New Drugs and Clinical Trial Rules. Unlike the experience in the EU and the USA, the researchers expect a complete cessation of use of animals in drugs-now that such changes in law will be made at the world’s largest democracy. The amendment will prepare a boost for 3D bioprinting that is developing in labs and start-ups that have burst in India over the past few years because of research.
3D bioprinting brings printed living cells and biomaterials layer by layer, replicating the cellular architecture found in bodies. Bioprinting is done to test drugs from pharmaceutical companies or build tissues or organs used for repair or replacing damaged ones.
The company Pandorum Technologies operating from Bengaluru is working on bioengineered ‘liquid corneas’ which are capable of regenerating human corneas. Co-founder Arun Chandru states, with the 2023 amendment, the team has avenues to use 3D bioprinted tissues instead of the long and arduous preclinical or animal studies. Contract research organizations are doing preclinical drug tests on its 3D bioprinted corneas, and Chandru says under this “less stringent scenario”, it has brought more revenue into the fold to compensate some research and development expenses. Biomedical engineer Falguni Pati, who heads the Biofabrication and Tissue Engineering Lab at the Indian Institute of Technology (IIT) Hyderabad, has developed diverse tissue models. He reports that the amendment will also fast-track models for eventual translation to industry.
As it stands, the industry looks promising, as the global 3D bioprinting industry was worth US$1.3 billion in 2022, and as per an Emergen Research report, it would be valued at US$8.64 billion by 2032. In December 2022, the Indian Institute of Science (IISc), Bengaluru, opened the first 3D Bioprinting Centre of Excellence with CELLINK, a Swedish bioprinter, focusing research on the heart, bone, cartilage, and cancer.
Specialized biomaterials
3D bioprints are constructed from scaffolding biomaterials called bioink which contain a polymer, living cells, and other ingredients for cell growth. Avay Biosciences, a commercial start-up based in Bengaluru manufacturing 3D bioprinters, produces four common bioprinting polymers: alginate, gelatin methacryloyl, agarose, and pluronics. It is trying at producing collagen-based biomaterials at an affordable price for the Indian market, says its chief operating officer Suhridh Sundaram. The extraction and purification of collagen obtained from animal byproducts happens to be a tedious and expensive procedure.
At the Biomaterials and Tissue Engineering Laboratory in IIT Guwahati, a group headed by materials scientist Biman Mandal is developing disease models to test drugs and create tissues and organs for transplant in humans. Mandal’s lab uses Indian silk as a biopolymer, since it is about 20 times cheaper than purified collagen. It has a unique set of biological properties offering specific sites for cell proliferation. One such silk variety from the north east of India, mulberry silk, has got the nod from the US Food and Drug Administration for use in the human transplantation field.
They have evolved eight different bioinks for bioprinting bone, cartilage, liver, pancreas and skin tissues.
“The cells require a specific environment, growth factors and the physical niche which these bioinks provide,” Mandal says. Hydroxyapatite and silk were added to produce bone bioink because they are known to enhance bone regeneration. β-D galactose was included into the bioink for liver cells to facilitate their attachment to the matrix.
At IIT Hyderabad, Falguni Pati and his team are making tissue-specific bioinks for cornea, esophagus, skin, and liver. This process involves isolating the cells by taking tissue samples from humans or other animals and then using the extracellular matrix to prepare a hydrogel. According to Pati, the cellular response and function of such bioprinted tissues are far better than those of biomaterials like collagen or gelatin.
The laboratory of Pati created a 3D bioprinted cornea to be able to substitute cadaveric corneas in corneal transplantation. Bioink preparation is using the extracellular matrix from cadaveric corneas that cannot be used for transplants.
For its liquid cornea, Pandorum came up with a hydrogel that simulates the different properties of the cornea like transparency and refractive index. It consists of a variant of hyaluronic acid and collagen that can be photo-cross-linked under visible light. More important, it contains nanosomes secreted by stem cells in the hydrogel to make it bioactive and promote tissue regeneration, says Chandru.
Lab to industry
The models are going to be adapted to the industry within the next few years. Pati says that the skin and cornea models will be ready for testing drugs and toxicity within a year. The team is currently formulating Good Manufacturing Practice protocols for its 3D bioprinted cornea and expects to start clinical trials in two years. Actually, Pandorum’s 3D human liver micro-tissues are already being used by pharmaceutical companies for drug testing, Chandru says. In the meantime, the company is seeking approval from the Drugs Controller General of India and the US FDA for the first human clinical trials of its liquid cornea KuragenX.
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