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Revolutionising medicine with the promise of growing human organs

Growing human organs holds immense importance in modern medicine, offering solutions to critical healthcare challenges. One of the primary benefits is addressing the persistent shortage of donor organs for transplantation. This scarcity often leads to long waiting lists and, tragically, the loss of lives. By cultivating organs in the lab, we can potentially bridge this gap and provide timely treatment to those in need.

Additionally, the ability to grow organs offers a path to personalized medicine. Everyone’s body is unique, and lab-grown organs can be tailored to match the recipient’s specific biological characteristics, reducing the risk of rejection and the need for immunosuppressive drugs. This personalized approach not only enhances patient outcomes but also minimizes the burden of post-transplant complications.

Ethical considerations also come into play. Organ donation, whether from deceased or living donors, raises complex ethical questions. Growing organs in the lab provides an ethically sound alternative, eliminating concerns about consent and the exploitation of vulnerable populations.

Furthermore, the field of regenerative medicine and tissue engineering opens new avenues for medical research. Lab-grown organs serve as valuable models for studying human biology, disease progression, and the efficacy of potential treatments. This knowledge contributes to a deeper understanding of various health conditions and the development of more effective therapeutic interventions.

In essence, growing human organs represents a significant advancement in healthcare, offering hope to patients, advancing medical science, and addressing ethical dilemmas associated with organ transplantation.

Biofabrication is the industrial production of biological tissues that can be used for infinite therapeutic applications, including for burn injuries or damaged vasculature, in toxicology screening to test the safety of drugs under development and to develop therapies to cure diseases including renal failure and diabetes.

Current cell, tissue and organ manufacturing practices are not scalable, consistent, or cost-effective. At the BioFabUSA human tissue foundry at the Advanced Regenerative Manufacturing Institute (ARMI) in Manchester, New Hampshire, they are redefining the biofabrication industry’s manufacturing technology and processes to bring projects out of laboratories and into manufacturing facilities.

Dean Kamen, founder of FIRST Robotics and Segway, as well as Deka Research and Development, is a disruptive force and he intends to bring that to bear on biofabrication. “I pointed out to President Barack Obama that the difference between scientific research and industry is huge We don’t even have the real roots of the industry that is going to take the science out of these labs and bring it to industry,” he told Obama.

The Advanced Regenerative Manufacturing Institute (ARMI), a member-driven, nonprofit organization, created BioFabUSA, one of 16 Manufacturing USA institutes, born from a federal initiative that originated during the Obama administration. BioFabUSA integrates cell and tissue cultures with advances in biofabrication, automation, robotics, and analytical technologies to create disruptive tools and scalable FDA-compliant manufacturing processes.

“When we first started ARMI, I said the dynamic range of people getting involved was going to be unprecedented,” Kamen says. “We grew to well over 100 members in a few years. To get an industry up from nothing, we’re going to need standards. We’re going to need systems. We need to create that substrate. We need this massive infrastructure to turn this into a high-volume business.”

Staffed by 67 employees, as well as embedded employees from more than 200 member companies, BioFabUSA has grown quickly since its inception in 2017. ARMI began with an $80 million grant from the US Department of Defence and a handful of member companies. Kaman’s vision is to not only facilitate the ability to grow human tissue for organs, but to automate the process and then democratize it to the point of providing machinery small enough to place in a doctor’s office.

“I told the Department of Defence I have mechanical engineers, system engineers, controls engineers,” Kamen adds. “I don’t have a single MD in my company. We know nothing about the world of synthetic biology. We know the engineering side of a lot of these things we do.”

Kamen set to work on recruiting leaders to steer the institute into disruptive waters. “I called John Abele, the co-founder and director of Boston Scientific,” he continues. “I called Martine Rothblatt, United Therapeutics CEO and the founder of Sirius Satellite Radio. The third person I called was Blake Moret, the CEO of Rockwell Automation. I knew him through FIRST Robotics.” Along with Dr Jim Weinstein, senior vice president for Microsoft Healthcare and former CEO of Dartmouth-Hitchcock, these five became the BioFabUSA board of directors.

Automation fills important role

Among the embedded people at ARMI/BioFabUSA are Rockwell Automation employees including Wayne Charest, Bio Manufacturing Project Application Engineer, and John Hatzis, global industry technical consultant, life sciences. “When we first came onboard, we were among the first to join ARMI in 2017,” Charest says. “The first year, ARMI was a manufacturing institute, which was made up by its members. We spent a lot of time the first year trying to teach the members about automation. We created a program called Automation 101.”

After the first year, Charest helped to create the tissue foundry, which was the first automated tissue line. Rockwell Automation supplies the technology that automates the tissue foundry. “Then we decided to build an experience centre. We couldn’t have gotten those done in the first five years without John Hatzis.”

Hatzis works with a variety of life-sciences companies. “We are getting to see the beginnings of an industry right here in New Hampshire,” he explains. “It’s been a great experience building these tissue factories.”

Rockwell Automation’s technology has become an integral driver of the scalable, modular, automated, closed (SMAC) system that has taken shape under the leadership of Tom Bollenbach, ARMI/BioFabUSA’s chief technology officer.

Generating cells is relatively easy, compared with the complexities of regenerating three-dimensional organs, such as kidneys, livers, hearts or lungs, all of which are in the works by ARMI member companies, explained Bollenbach. “How do you quality-control living tissue?” he asked rhetorically. The challenges come specifically in determining how to transport fuel—nutrients and oxygen, for example—to interior cells and how to subsequently remove waste products.

Data has become a key enabler for finding correlations that help to predict behaviors in cells that need to accomplish these types of goals. Digital technology keeps moving the needle. “Fifty years ago, people scoffed at what you would need a computer for,” explained Kamen. “We’ve digitized the world in a way that people wouldn’t have predicted in the days of transistors.”

Kamen compared the potential impact of democratized organ regeneration to the way wireless communication has changed our lives. “There are 2 billion transistors in a cellphone,” he explained. “There are about 2 billion cells in a pancreas. What would you pay for a new pancreas for your child? The United States is going to spend 21% of its GDP on healthcare, mostly on chronic treatments. If we build an industry that allows people to replace organs, it will be more impactful on people’s lives than cellphones.”

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