As a technology, bioprinting seeks to revolutionize medical research and healthcare, paving the way for more holistic, patient-driven solutions. At the same time, it is important to remember that bioprinting is just a tool, and what is truly innovative about it are the applications and uses being developed for it across the world. One company, which has not only pioneered its own bioprinting technology but is also developing a diverse range of applications for its platform, is South Korean company T&R Biofab.
T&R Biofab—which stands for Tissue Engineering & Regenerative Medicine, Biofabrication—may not be as well known as some other leading bioprinting firms, but the company has been around for nearly a decade and has been behind some truly groundbreaking projects, including a recent partnership with B BRAUN (Korea) to distribute bioprinted craniofacial bone implants. We recently had the opportunity to catch up with Paulo André Marinho, Head of Scientific Strategy at T&R Biofab, to talk about how far the company has come, what solutions it currently offers, and how it is giving back with life-changing patient-specific implants (PSI).
The beginnings of T&R Biofab
To start, let’s cover the basics. T&R Biofab was founded in 2013 by two alumni and their advisor professor from POSTECH university in the city of Pohang: Professor Yun, Professor Shim and Professor Cho. Together, they set to work to engineer a top-quality bioprinting technology, which would form the foundation of their company’s offering. This development remained the initial focus for years and in 2018, T&R went public. At this point, the company turned its attention to the next stage: commercializing its technology and creating a sustainable business model.
“In the beginning, T&R was more tech driven,” Marinho explains. “Now, it is very market oriented and consumer-centric, focused on what the pharmaceutical industry wants, what patients need, etc.” As part of its strategy, T&R Biofab ultimately decided on a multifaceted approach. First, it would not commercialize its bioprinting hardware. “If we can make cars, computers, semiconductors, why would we sell steel and iron,” he adds. “We focus on what we excel in, which goes beyond the printers. We are fully capable of doing the next step and producing key IP that can be beneficial for T&R, the scientific community and the world in general.”
T&R Biofab today has many business avenues and is establishing a number of revenue streams. “We work mainly with three big businesses,” he says. “One is printed scaffold, one is extra cellular matrix (ECM), including many types of biomaterials, and the third is induced pluripotent stem cells (IPS), a Nobel-prize winning technology.”
Within the first category, scaffolds, the company has three main product groups: biodegradable hard scaffolds, which include PSIs, orbital and nasal implants, orthopedic implants and more; soft scaffolds, such as acellular dermal matrix (ADM), wound healing dressing and a mesh used as a hemostatic agent; and cell therapy, which includes organ patches, skin and more. Marinho points out that some of these, especially the soft scaffolds, are not new or especially innovative, but are part of a well-established and lucrative market. In this sense, producing soft scaffold products will enable T&R Biofab to boost its revenue, enabling it to undertake increasingly ambitious projects, like patient specific implants.
Building a business for PSI
As we saw, patient-specific implants fit into T&R Biofab’s biodegradable hard scaffold business. “When you talk about biodegradable scaffolds, we have four major areas we’re working in: orbital mesh, nasal mesh, PSI and implants for neurosurgery with B Braun.” Today, the company (through its partners at hospitals) has deployed about 30,000 nasal mesh implants, a couple thousand orbital implants, and over two hundred patient-specific implants. These have been largely produced at T&R’s manufacturing facility in Siheung, not far from central Seoul. “In our fully certified GMP facility, if all printers are operated at full capacity, we could generate close to 10,000 scaffolds per month without night shifts,” he says.
In anticipation for greater production demands (following an increase in partnerships), the company is also expanding its facilities. “By the end of 2022, our production manager Dong-Hyuk Lim thinks that we will be able to at least double the production capacity and likely triple it. Our decision is also in alignment with our regulatory affairs business. We recently got European certification to commercialize some of our products and we are on the way to get approvals with the FDA in the US and similar approvals in China.”
What is particularly interesting when it comes to T&R’s PSI production is that compared to the other hard scaffold products which can be mass produced, the patient-specific implants are not especially profitable. Marinho explains: “As a company, we understand that off-the-shelf products are much more profitable since they are easy to scale up when there is a demand; but the results of the PSI work are undeniably meaningful, not just for the medical and scientific community, but especially for the patients. At T&R, we believe it is our social responsibility to keep contributing to the community with technologies that can’t be found elsewhere.”
Life-changing 3D printed implants
The amazing and life-changing potential of bioprinted PSIs is exemplified in one of T&R Biofab’s case studies—a procedure that was undertaken in partnership with surgeon Dr. Jung Hwan Baek back in 2018. The doctor was treating a patient with a rare condition which affects several tissues of the body including skin collagen and bone development. In the patient’s case, the disease had caused a deformation of the cranium as well as of the cheek and mandible. “He needed at least three independent PSIs,” Marinho tells us. “So that’s what we did.”
What is particularly interesting about this case study is that within the approved range of specifications for the bioprinted biodegradable implants, the doctor chose the most porous geometry. In other words, T&R Biofab designed the three implants based on a CT scan of the patient and optimized their structure to have a very porous texture to meet the doctor’s specifications. The implants were then bioprinted using polycaprolactone (PCL), a biocompatible, biodegradable material.
“There is a reason the doctor wanted the implants so porous. Because the patient’s deformity was so severe, the doctor believed that the PSI alone wouldn’t be sufficient,” he explains. “So, his strategy was to use the PSI as the core material and saturate it with other materials approved by the MFDS (formerly KFDA). He combined existing products, such as autologous cells, growth factors, artificial bone grafting and acellular dermal matrix.”
This strategy was implemented to prevent unwanted soft tissue from growing into the implant instead of bone. The PSI was sealed with a mix of these pre-existing treatments to encourage the growth of only bone instead of less strong tissues. “I’ve never seen anything like it,” Marinho states. “And the results are very compelling.” Critical to this treatment was T&R’s ability to produce patient-specific implants as well as devices that met the doctor’s specific requests.
“The case study demonstrates how PSIs honor the title of tailor-made solution,” Marinho continues. “It is not only about building a construct that fits the patient but also about adapting to surgeon requests and specifications for the best treatment. For this reason, we have team members fully dedicated to modeling these products. In this case, T&R’s Eunju Lee worked closely with the surgeon to design the bioprinted implants.”
Within a month of the implantation, the T&R Biofab team and doctor could already see a big difference in terms of both cosmetic effect and the beginning of integration. “What is amazing is that we had a follow up last month,” he adds. “If you compare the results from one month after the surgery to what it is now, three years later, there is significant bone growth.” For the patient, the surgery has been transformative, providing a strong clinical outcome in terms of aesthetics but especially strengthening the patient’s cranium and jaw.
The excellent results of this specific case has resulted in other similar treatments by the same doctor using T&R biodegradable implants. According to Marinho, the doctor has used a similar technique for cartilage regeneration and is planning to use the technology for other procedures such as chin reconstruction.
Beyond this collaboration, T&R also hints at other highly innovative projects it is working on, including a bioprinted trachea with printed cells, a landmark project that is now undergoing trials. Unlike other bioprinted implants which are embedded with cells, the bioprinted trachea is printed with cells—a potentially game-changing technique that T&R Biofab is understandably very excited about. Other projects on the docket include autologous heart-cell spheroids for treating infarction (pre-clinical stage) and ear scaffolds (clinical stage). As the company matures and establishes itself in Korea and abroad, we’re sure to hear of more bioprinting achievements it has undertaken. In fact, we suggest you keep an eye out for our upcoming bioprinting eBook in February 2022 for more from T&R Biofab.
This article was written in collaboration with T&R Biofab.