Companies desire to get scientific backing to substantiate efficacy claims of their products. This becomes necessary especially for companies that wish to expand their customer base from traditional herbal enthusiasts to the larger, more skeptical public.
The difficulty of conducting animal and human trials is the biggest impediment to the development of science-backed natural products. The availability of suitable subjects to conduct a double-blind, placebo-controlled human trial is another impediment that is faced by a natural products company that is brave enough to initiate a human trial.
Conducting a human trial is a complicated, time-consuming and expensive affair. It is not just the regulatory process that is intimidating, but other issues such as culture, ethics and finance and fear of failure are additional impediments.
Bioprinted human tissue created using 3-D bioprinters can help reduce these concerns. This is making it possible to conduct trials on human tissue safely. There are no ethical or cultural issues associated with this mode of testing. Maybe going forward, the need for intermediary animal trials may come to end, and scientists could test directly on live human tissue.
3-D bioprinters and live tissue modeling have led to an increase in demand for 3-D cell tissue. According to BCC Research, the demand for this tissue is estimated to reach US$2.2 billion by 2019. Tissue modeling work is largely being done by research institutions. For instance, John Hopkins Bloomberg School of Public Health created a mini brain organoid with all neurons and other critical brain cellular compositions.
A computer-aided design (CAD) application is used to create the 3-D format on the screen. This output is fed into the 3-D bioprinter, which operates on three axes like any 3-D printer. There are two fundamental differences, though, between a regular 3-D printer and a bioprinter.
The ink used in a 3-D bioprinter is composed of living cell tissue that is injected with a syringe. Further, it is critical that in the process of printing and setting, the tissue stays alive. Ultraviolet (UV) light used in regular 3-D printers would kill living tissue. Danny Cabrera, founder of the biotech startup Biobots, said when tissue is exposed to this light, it continues to remain alive during the print process.
Cabrera’s company has been able to manufacture bioprinters at a cost of $10,000 a unit. This is a dramatic cut from the earlier cost of $200,000 for a 3-D bioprinter. As the technology evolves, it is inevitable that it will get commoditized and further drop in cost of bioprinters will result. This should make 3-D bioprinters within reach of even small natural product companies. They will then able to test their products using this biotech innovation.
Current capability to bioprint living tissue is still quite restricted. Organovo, another biotech company, is bioprinting human liver and kidney tissue.
Living tissue 3-D printing should start happening on industrial scale in a few years. This will give a huge boost to pre-clinical drug and other material testing on live human tissue. Other applications and use cases will emerge in time. And startups such as BioBots will evolve to take innovation to the next level.
Some of the bigger pharmaceutical, biotech and cosmetic manufacturers have started leveraging this technology to test their products. On April 1, 2015, Organovo entered into an agreement with LÓreal USA Products Inc.
The two agreed to collaborate on the development of skin tissue models using a bioprinting platform. LÓreal will be using skin tissue models for the development, manufacture, testing, evaluation and sale of nonprescription cosmetic, beauty, dermatology and skin care products and nutraceutical supplements. This disclosure is made in an SEC filing.
BASF too has entered into an agreement with a French biotech company that is also bioprinting tissue. BASF will use this technology to improve its skin model Mimeskin, claimed to be the closest equivalent to the original physiological tissue of human skin.
It is important to note that the agreement between LÓreal and Organovo includes testing of nutraceutical formulations. The deal between Nestle and LÓreal and similar deals indicate 3-D bioprinted human tissue will be used to test nutraceutical formulations. This should open the way for use of this technology by natural product manufacturers, too.
Sudhir Ahluwalia is a business consultant. He has been management consulting head of Tata Consultancy Services, an IT outsourcing company in Asia, business advisor to multiple companies, columnist and author of upcoming book on herb, “Holy Herbs." He has been a member of the Indian Forest Service.