regenHU CEO: Bioprinting Will Strengthen OrganTrans Project to 3D Print Liver Organoid

The European consortium OrganTrans is preparing to develop a tissue engineering platform capable of generating liver tissue. The proposed automated and standardized disruptive alternative solution to organ donation for patients with liver disease will stand on 3D bioprinting know-how from Swiss biomedical firm regenHU. Coordinated by Swiss research and development center CSEM, the eight partners and two transplantation centers engaged in the consortium will be using regenHU’s 3D bioprinters to produce organoid-based liver constructs with organoid laden bioinks.

In April 2020, we reported that OrganTrans would tackle the important healthcare challenge of end-stage liver disease (ESLD) by capitalizing on advancements in the regenerative medicine field, like using biofabricated liver tissue, to develop an entire value chain from the cell source to tissue engineering, biofabrication, post-processing and testing, and liver transplantation under the “compassionate use exemption” regulation (which provides an important pathway for patients with life-threatening conditions to gain access to unproven human cells and tissue products). To understand the key role of biofabrication in this innovative project, 3DPrint.com asked regenHU’s new CEO, Simon MacKenzie, to tell us more about the challenges that lie ahead for the European consortium and his company.

regenHU CEO Simon MacKenzie (Image courtesy of regenHU)

The project officially began in January 2020, what can we expect when it ends in December 2022?

The current goal of this project is to create a functional biofabricated liver construct that can be implanted into a mouse model. I consider that the OrganTrans team will accelerate new solutions for patients with liver failure. It is challenging, but we do envision successful in vivo trials. Of course, this major achievement will not be the end of the story; significant work and research will still be required to transfer these results to human clinical trials. The major remaining challenges will probably be the process scale-up to produce larger tissue and regulatory aspects.

Will this research be groundbreaking to treat liver disease in the future?

Demonstrating the feasibility of the approach in a mouse model will be groundbreaking for the disease because it will demonstrate its potential as an alternative to transplantation. Diseases like NASH [nonalcoholic steatohepatitis, an aggressive form of fatty liver disease] are increasing dramatically, and likely to be a leading cause of death within the next few years. Moreover, the difficulty of detecting the disease until it is potentially too late leads to significant challenges for therapeutic intervention, meaning transplantation will remain the main option for severely affected patients. This well-recognized need, along with the lack of donor organs will ensure bioprinted livers will continue to be well funded. But the value of the project goes beyond liver disease, as the new technologies developed in the frame of OrganTrans will not be limited to liver applications. They relate to the challenges of biofabrication of any organoid-based tissue, which can potentially be beneficial for a large variety of indications.

Can you tell me more about the role of regenHU within the OrganTrans consortium?

Such a complex and ambitious endeavor needs very different and complementary knowledge and competences. Teamwork will be a central element, first to enable, then to accelerate, these new solutions. With this in mind, we have been reorganizing regenHU to bring better project collaborative capabilities to this project, and others like it that we are engaged in. regenHU is a pioneer and global leader in tissue and organ printing technologies converging digital manufacturing, biomaterials, and biotechnology to lead transformational innovations in healthcare. We focus on delivering advancements in the instruments and software required for tissue engineering, and our technology evolving along with the biological research of our partners. We, therefore, consider these partnerships with the scientific community critical for our development.

An outline of the OrganTrans project (Image courtesy of OrganTrans)

regenHU is one of the largest contributors to this project, is this part of the company’s commitment to regenerative medicine?

We can see the need for biotechnology solutions for a wide range of disease states. Our strengths are in engineering the instruments and software necessary to allow the producers of biomaterials and the suppliers of cells to combine their products to achieve functional tissues and organs. Our commitment is to provide disruptive technologies that will enable the community to make regenerative medicine a reality, with precision and reproducibility in mind, for today’s researchers and tomorrow’s industrial biofabrication needs. One of the key challenges is the current limitation in the scale and volume of bioprinting which is linked to the reproducibility of the print. To progress into the manufacture of medical products, bioprinters will need to operate at a scale beyond current capabilities. We design our instruments with these goals in mind and have assembled a team to solve the many challenges to achieve this.

How advanced is the bioprinting community in Europe?

The 3D bioprinting field is several years behind mainstream 3D printing, with the industrialization of the instruments, biomaterials, and cells required before bioprinting can progress to commercial-scale biofabrication. However, as with continued development seen in 3D printing, the technology convergence required for tissue and organ printing that changes medical treatments will become a reality through the efforts of engineering companies like regenHU, biomaterial developers, and human cell expansion technologies, being combined in projects such as OrganTrans.

As the newly appointed CEO of the company, how do you feel taking on this project?

Successfully entering the OrganTrans consortium is just one part of the company. regenHU investors see my arrival as the catalyst to bring regenHU to the next stage in its evolution. Our goal remains the production of industrial biofabrication instruments capable of delivering the medical potential of bioprinting, novel bioinks, and stem cells. To achieve this, we are enhancing the team and structure of the company, bringing forward the development of new technologies and increasing our global footprint to better support our collaborative partners. I have spent many years in regenerative medicine and pharma and can see the potential of bioprinting to revolutionize many areas of medical science, so joining regenHU was an easy choice. As CEO, my main role is to provide the right support structure to enable our entrepreneurial engineering teams to thrive and be brave enough to push boundaries. Additionally, as we cannot achieve our end goal on our own, I am here to nurture the important connections with our user community. Only by listening to their valuable insights and solving problems with them, we will push the technology onward.

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New Facility for Bioengineering Research Opens in Los Angeles

In a world eager to solve the problem of rejection in organ transplantation, a young American scientist developed a breakthrough test in 1964 that would help establish the compatibility of tissue types between organ donors and patients in need of transplants. Even though, today, efforts to meet organ transplant demand are shifting toward the field of bioengineering, as researchers search for ways to recreate complex organs with patient-derived cells, the legacy of that scientist, Paul Ichiro Terasaki, continues to inspire discoveries in transplant medicine through his philanthropic ventures.

The Terasaki Institute for Biomedical Innovation (TIBI), a nonprofit research organization established by Terasaki, professor emeritus of surgery at the David Geffen School of Medicine at the University of California Los Angeles (UCLA), will open the doors to a new facility in 2022. The newly-acquired addition will house interdisciplinary research in bioengineering, micro- and nanoscale technologies to enable transformative biomedical innovation as part of continuing research to solve the biggest problems related to organ transplantation and beyond.

Earlier this month, the Terasaki Institute announced the revamping of a building in the Woodland Hills area of the city of Los Angeles. Once home to the Weider Health and Fitness Center, created by bodybuilder and entrepreneur Joe Weider, the two-story building will be custom-designed to house the latest technology in cutting-edge research and will provide 50,000 square feet of floor space for up to 200 employees.

Located just 22 miles north of the original Terasaki Institute facilities in Westwood, the new space devoted to laboratory research will be designed to accommodate multiple teams of scientists, who will be developing bioengineered systems, devices, and other products with several biomedical applications. This new facility will be fully equipped to enable such technologies as tissue engineering and regeneration, biofabrication using 3D printing, nano- and micro-engineering, stem cell engineering, and the creation of human organs on chips.

When the new facility is inaugurated, with the renovation of the building set to begin in fall 2020, it will become the Terasaki Institute’s third research facility. In addition to the ample space and unique design features of the laboratory, the new facility will include in-house technology translation capabilities to be able to build prototypes and scale models of devices engineered by the institute. It will also be able to accommodate meetings, seminars, and conferences to further the education and exchange of ideas among its researchers and collaborators.

“I’m very excited about the addition of the new building to the Terasaki Institute. I believe that this addition will give us needed research space to bring together a number of leading scientists in our efforts to develop the next generation of biomedical innovations,” said Terasaki Institute’s new director and CEO, Ali Khademhosseini. “I’m particularly excited about furthering the great legacy of the Weider family and the building’s history in promoting health and fitness by focusing on individualized cures and diagnostics.”

Previously at Harvard Medical School, the Wyss Institute for Biologically Inspired Engineering, and most recently at UCLA Bioengineering, Khademhosseini has been an influential figure in pushing bioengineering forward. His research in regenerative medicine, tissue engineering, and micro- and nanotechnologies for the treatment of diseases has been related to advancements that allow reprogramming of adult cells to become progenitors, as well as editing genes. The bioengineer has also created a technique that uses a specially adapted 3D printer that could help advance the field of regenerative medicine by making it possible to 3D print complex artificial tissues on demand. He has also established the Khademhosseini Lab, an industry-leading tissue engineering lab that is co-sponsored by both MIT and Harvard and acts as a strategic partner to 3D bioprinting startup BioBots.

Ali Khademhosseini (Image: Ali Khademhosseini)

Stewart Han, president of the Terasaki Institute, has been working hard overseeing the planning and renovation of the new building: “It is exciting to be able to create a brand-new laboratory and research facility from the ground up, and it will greatly enhance our research capabilities when it’s completed. We also know that the new building will facilitate the future growth of our institute.

Founded in 2001, the Terasaki Institute was made possible through an endowment from the late Paul Terasaki, and it is expected to continue leveraging scientific advancements that enable an understanding of personalized medicine, from the macroscale of human tissues down to the microscale of genes, as well as to create technological solutions for some of the most pressing medical problems of our time.

Paul Terasaki in front of the Terasaki Life Sciences Building UCLA. (Image: Leslie Barton/UCLA)

“The board of the Terasaki Institute is very excited about the purchase of the new building in Woodland Hills, and we look forward to developing it into a world-class biomedical research center,” said board chair and diagnostic radiology specialist Keith Terasaki. “My father, the late Paul I. Terasaki, started the Terasaki Institute in hopes that it will make impactful discoveries in medical research. This new research facility will enable us to do so.”

To the field of transplant surgery, transplant pioneer Paul Terasaki enabled a broad understanding of organ transplant outcomes around the world. More than 70 years after his original discovery, patients still rely on organ donor transplants and the fundamentals of Terasaki’s laboratory developed tissue typing tests are still used today for the determination of transplant compatibility. Nonetheless, the Terasaki Institute envisions a world where personalized medicine is available to all. So, as the researchers at the institute continue to address the challenges that can finally advance the field of organ transplants from human donors to bioengineered artificial organs, they might bridge the gap between sickness and health. With one of the most productive 3D printing researchers as director, Khademhosseini, and a new facility to further explore biofabrication technology, we can expect to hear much more from the Terasaki Institute in years to come.

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A Guide to Bioprinting: Understanding a Booming Industry

The success of bioprinting could become the key enabler that personalized medicine, tissue engineering, and regenerative medicine need to become a part of medical arsenals. Breakthroughs in bioprinting will enable faster and more efficient patient care and recovery. Biofabrication could be used to reshape the foundations of drug development, medicine, cosmetics, organ transplantation, and many other fields. It will transform the way doctors repair damaged ligaments, recreate tissues, and even reproduce the layers of the skin.

We are entering an era of bioprinting revolution. But to understand the role that bioprinting will play in the future, it is important to look back at how early discoveries in the field provided a strong basis to push its capability forward:

  • Back in the ’90s, Anthony Atala, pediatric surgeon, urologist, and director of the Wake Forest Institute for Regenerative Medicine (WFIRM) in North Carolina, created by hand bladders, skin, cartilage, urethra, muscle, and vaginal organs. By the end of that decade, the Institute used a 3D printer to build a synthetic scaffold of a human bladder, which they then coated with cells taken from their patients and implanted it, preparing the stage for bioprinting.
  • Then in 2002, scientists from Harvard University printed two-inch-long mini-kidneys capable of filtering blood that was then transplanted back into genetically identical cows, where they started making urine. The novel research raised the prospect of using stem cells taken from human patients with kidney failure to create new organs for transplant.
  • However, it wasn’t until 2003, when bioengineering professor Thomas Boland adapted a Hewlett-Packard inkjet printer in his lab at Clemson University to begin printing a bioink made of living bovine cells suspended in the cell-culture medium, that bioprinting began to materialize. This led to the creation of the world’s first 3D bioprinter, capable of creating living tissue from a solution of cells, nutrients, and other bio-compatible substances.
picture os a man using the bioprinter on a limb

A member of WFIRM team operates with the bioprinter (Image: WFIRM)

Twenty years later, researchers still face challenges as they continue working with bioprinters and bioinks. Even though there has been an increasing adoption of the technology, the extent of its potential has not been fully exploited. From choosing the bioinks to actually bioprinting human tissues and organs, this new field is quickly becoming the go-to technology that bioengineers, researchers, and hospitals need to evolve from lengthy and cumbersome manual work to scalable and replicable results.

How Well Do you Know Bioprinters? (or How Bioprinters Work and Who Makes Them)

Bioprinters work by extruding cells and other biomaterials contained in bioinks, from syringes that deposit the material layer by layer to create different types of tissues or organ-like constructs. The technology behind the bioprinters vary. Nonetheless, to date, the three main and most popular bioprinting technologies are extrusion, inkjet, and laser-based bioprinting. Some mainstream examples are:

  • Some manufacturers, like Cellink or Allevi, use pneumatic-driven extrusion systems that pump high-pressure air in a cartridge to force bioinks to flow through a nozzle. 
  • Other fabrication systems, such as the one designed by Poietis has laser-assisted bioprinting that allows cells to be positioned in three dimensions with micrometric resolution and precision to design living tissue.
  • Another type of bioprinting technology uses a stereolithography-based bioprinting platform. Vendors using this process include Volumetric and Cellink’s jointly produced Lumen X projection stereolithography based bioprinter.
  • Another project that could revolutionize the way surgical procedures are performed is handheld bioprinters; these systems enable surgeons to deploy cells — or material to aid in cellular growth — directly into a defect site in the body, such as severely burnt skin, corneal ulcerations or bone. One of the most talked-about handheld bioprinters has been Australia’s University of Wollongong BioPen, allow surgeons to repair damaged bone and cartilage by “drawing” new cells directly onto bone in the middle of a surgical procedure. Although still in pre-clinical trials, these devices have attracted the attention of healthcare practitioners due to its versatility.

A few of the main manufacturers supplying the market include 3D Bioprinting Solutions, Allevi, Aspect Biosystems, Cellink, nScryptregenHuInventiaRegemat3DPoietis, and more. Last year, 3DPrint.com counted 111 established bioprinting firms around the world. Mapping the companies that make up this industry is a good starting point to understand the bioprinting ecosystem, determine where most companies have established their headquarters and learn more about potential hubs, like the one in San Francisco.

Types of Bioinks

3D bioprinters use bioinks. Bioinks are substances made of living cells that can be used for 3D printing complex tissue models — they mimic an extracellular matrix environment to support the adhesion, proliferation, and differentiation of living cells. Choosing which bioink to use can be challenging. To date, we have witnessed researchers using bioinks based on several biomaterials, such as alginate, gelatin, collagen, silk, hyaluronic acid, even some synthetic-biomaterials-based-bioinks.

The promise of hydrogels. A macromolecular polymer gel constructed of a network of cross-linked polymer chains, hydrogels are able to meet the stringent requirements of cells and are the basis of almost all bioink formulations. As stated in “Engineering Hydrogels for Biofabrication”, published in Advanced Materials, “hydrogels are particularly attractive for biofabrication as they recapitulate several features of the natural extracellular matrix and allow cell encapsulation in a highly hydrated mechanically supportive threedimensional environment.” This makes hydrogel-based bioinks a very promising choice for many researchers and bioengineers.

Bioinks from patients’ cells. The biomaterials can also use a patient’s own cells, adult stem cells, manipulating them to recreate the required tissue. The source of the cells varies depending on what researchers are bioprinting. For example, in the case of Alzheimer’s disease, experts at the University of Victoria in Canada, have bioprinted neural tissues using stem cells as a tool for screening drug targets for the disease. The ability to program patient-specific cells is the beginning of customized bioprinting since the unlimited potential of these cells can be used to regenerate or repair damaged tissue. 

Polbionica’s bioinks (Image: Polbionica)

What is Bioprinting Good For?

What is most exciting about bioprinting, are the many ways that doctors and researchers are using currently available devices in the market or are creating their own systems to facilitate new processes and applications. The orchestrated interaction between machine and user has led to innovation that could reinvent the world of tissue engineering.

Moving oncology forward:  Bioprinting is being employed in the battle against cancer, whereby scientists create tumor models for research. Modeling cancer using 2D cell cultures fails to accurately replicate the microenvironment of tumors. This is why scientists have turned to biofabrication tools to make three-dimensional models that mimic the intricate in vivo tumors. These models help test anticancer drugs; aid scientists in understanding the underlying causes of metastasis, and can even personalize treatment for individual cancer patients. There have been plenty of initiatives that apply bioprinting to oncology. These range from immersion bioprinting of human organoids to printing cancer tissues in 3D

Microtumors (Image: CTI Biotech)

The market for oncology-oriented bioprinting seems sure to grow. The number of patients suffering from the disease continues to go up. In 2018 alone there were 17 million new cases of cancer worldwide, and projections suggest that there will be 27.5 million new cases of cancer each year by 2040. What that effectively means is that we are witnessing an increase in oncology bioengineering research and whether it is for glioblastoma, bone cancer tumors, or lung models with tumors, the implications can be profound since the ability to use bioinks and bioprinters to create tumors frees researchers of the many ethical concerns associated with testing as well as reduces the costs associated with such research activities. 

Building scaffolds: Probably the most important practical use for bioprinting at the present time is in regenerative medicine. For instance, in 2019, researchers from North Carolina State University (NCSU) and the University of North Carolina at Chapel Hill created a 3D biomedical fiber printer used to create biocompatible scaffolds. Also, Harvard researchers working in Jennifer Lewis’ Lab at Harvard´s Wyss Institute for Biologically Inspired Engineering and John A. Paulson School of Engineering and Applied Sciences (SEAS), came up with a much talked about breakthrough new technique, the SWIFT method, that allows 3D printing to focus on creating the vessels necessary to support a living tissue construct. A team of researchers at Texas A&M University have even developed a 3D printable hydrogel bioink containing mineral nanoparticles that can deliver protein therapeutics to control cell behavior.

Limitations of Bioprinting

Though we heard it many times before, knowing that someday 3D printed artificial organs could eliminate the need for an organ donor waiting list is comforting. Creating personalized replacement organs sounds like the solve-all solution to the organ shortage crisis, yet, a functional organ compatible for human implantation may be decades away. Today, 3D printed organs are still raw to be used for transplantation and lack the vasculature required to function within the human body.

Creation. Last year, mainstream news outlets headlined a story about researchers who had 3D printed a heart. However, the published scientific paper behind that story described how a group of scientists from Tel Aviv, Israel, created bioink out of heart cells and other materials from a patient, and were able to develop cardiac patches and ultimately, 3D print comprehensive tissue structures that include whole hearts. The tissue was shaped in the form of a tiny heart that was kept alive in a nutrient solution. The paper expresses how this development could not function like a real heart since the cells in the construct can contract, but don’t yet have the ability to pump.

This was certainly not the first heart to be 3D printed, yet Tal Dvir, who led the project at Tel Aviv University’s School of Molecular Cell Biology and Biotechnology, indicated that never before had it resulted in an organ “with cells or with blood vessels.” It was an amazing breakthrough for the field, and it proves that biotechnology has made significant advances, but it is still a long way from creating organs that can be transplanted to people, considering that the vasculature — the network of blood vessels that feeds the organ — remains a challenge, but scientists are determined to troubleshoot these issues.

So, no matter how enticing the idea of successfully bioprinted organs sound, stories like this remind us to keep the hype in check, making the work of news outlets fundamental for reporting advancements in research and medical breakthroughs (which usually take much more time).

Where to Next?

Organ bioprinting. The application of 3D bioprinting will be a game-changer in medicine, as the machines successfully replicate tissues and organs, build muscles and cartilage, and enable the adoption of customized medicine. The long-term dream for bioprinting has always been the routine printing of body organs. Current ongoing projects include Michal Wszola’s 3D bioprinted bionic pancreas or Organovo’s 3D bioprinted liver.

The space frontier. Bioprinting in space could hold the key to developing fully functional organs. This is because bioprinting without gravity allows organs to grow without the need for scaffolds. The National Aeronautics and Space Administration (NASA) considers that terrestrial gravitation represents a significant limitation, while a gravity-free environment, magnetic and diamagnetic levitation will allow for biofabrication of 3D tissue constructs with a scaffold-free and even nozzle-free approach. Some bioprinters have already been launched and used in space.  This includes nScrypt and Techshot’s BioFabrication Facility (BFF), or the Organaut 3D bioprinter created by Russian biotech firm 3D Bioprinting Solutions and Roscosmos, the Russian state corporation responsible for space flights.

Healthcare at its best. More prosaically, biomaterials specialist and a professor of biofabrication at Queensland University of Technology, Australia, Mia Woodruff, has been advocating the hospitals of the future for years. She has an exciting vision of a future where the fabrication of patient-specific replacement tissue and organs is safe, cost-effective, and routine. Though perhaps years from happening, her vision is in tune with what many think bioprinting could become, that is, with enough researchers, companies, and funding.

An astronaut aboard the ISS using Techshot’s BioFabrication Facility or BFF (Image: Techshot/NASA)

Coming regulation. Back here on Earth, there will be a growing need for common guidelines for bioprinting to make the process more standardized. In the EU, for example, there currently no particular regulatory regime governing the whole bioprinting process, but piecemeal legislation is relevant in relation to tissue engineering and regenerative medicine. While the Food and Drug Administration (FDA) of the United States plans to review the regulatory issues related to the bioprinting of biological, cellular and tissue-based products in order to determine whether additional guidance is needed beyond the recently released regulatory framework on regenerative medicine medical products.

As the development of the technology strongly advances and proves successful for researchers, we will surely continue to observe brilliant minds perfecting devices and biomaterials, envisioning new systems for future needs, especially as startups emerge out of universities and research institutes, and established companies upgrade their machines to face the limitations we previously addressed in this article.

Still, there is a long way to go, what was largely built so far is a very promising technology. For instance, fully functional organ fabrication for transplantation might take decades. Nonetheless, the unquestionable contribution of bioprinting to so many fields remains an incentive to invest in this area to overcome medical challenges and to move the healthcare industry in a different path, where technology will not only aid in curing diseases but also guiding people by helping them stay healthy, recognizing symptoms early and personalizing solutions in real-time. 

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Bangladesh: Brac University Student Centers Thesis Around 3D, 4D & Even 5D Printing in Medicine

Fatema Tuz Zohra Moonmoon has submitted a thesis, ‘Possibilities of 3D & 4D printing technologies for personalized medicine’ to Brac University, exploring the ways digital fabrication may continue to impact the medical field.

While medicine has always been an area of incredible breakthroughs, innovation, and even what many refer to as miracles, scientists and doctors still have infinite obstacles to surpass when it comes to improving the quality of life for patients, saving lives, and fighting disease. 3D printing has offered new insight and efficiency, allowing for better diagnosis and treatment of medical conditions with 3D printed models and devices, as well as paving new avenues for the training of medical students, surgeons, and offering pre-operative planning devices too.

Oral medications are an area still rife with challenges for meeting the needs of patients, too, and scientists have fabricated numerous vehicles via 3D printing for offering patient-specific treatment regarding dosages, time-release, shapes, sizes of pills, and more.

“3D printing enables customers to design and create their individual items without producing huge waste,” states the author. “Presently through development of ‘4D printing’ it is anticipated that this technique will be able to bring socio-economic change in the following decade.”

Moonmoon is certainly not alone holding the opinion that 3D printing is expected to transform pharmaceuticals, centered around patient-specific treatment—allowing for personalization that can even span as far as multi-drug combinations.

3D Printing Process (Kilicarslan, Ilhan, Inal, & Orhan, 2018)

Printlets are becoming increasingly popular as scientists experiment with digital fabrication, and Aprecia Pharmaceuticals rocked the news headlines in 2016 when the FDA approved Spritam, the first 3D printed tablet—developed for epilepsy patients. Data provided by the author states that “The worldwide 3D printed medicinal devices market is expected to grow at a CAGR of 18.1% during the forecast period 2017– 2027.”

Global 3D Printed Medical Devices Market Share (%)(Trenfield, Goyanes, et al., 2018)

Moonmoon separates medical 3D printing into four categories:

  • Organ models to aid in surgical treatment analysis
  • Permanent non-bioactive implants
  • Fabricating local bioactive and biodegradable scaffolds
  • Directly printing tissue and organs

3D Printed Maxillary Bone (Nguyen, Narayan, & Shafiee, 2018)

Bioprinting has become a tremendous area of research, showing great potential for the eventual fabrication of human organs—meaning that patients can avoid the rigors of waiting lists and the continued risk of organ rejection (as the implanted cells are their own).

3D Printed Body Parts(Song et al., 2018)

So, where does 4D printing fit into all this, you may wonder? Taking digital fabrication to an all new elevated level of magic, users can create materials and products that morph to their application. Usually triggered by environmental factors like temperature or moisture, 4D materials deform and then return to their original state.

Diagram by Jean-Claude Andre, 2016

For medical applications:

“The medications will be able to customize according to the patient’s need. It will enable specialists to tailor the exposure and dosage levels of drug for individual patients,” states the author.

“With the help of an external stimulus, shape-memory materials (SMM) can restore their form even after twisting. Once triggered by temperature, moisture or by light enactment utilizing illumination, SMP can change their unique shape from one to several shapes (Gillaspie et al., 2016). On the other hand, the SMPs can be magnetically induced into thermoplastics by integrating nanoparticles. SMPs have revealed abundant utilizations in biomedical applications, small scale electromechanical systems and self-deployable structures.”

SMPs also offer the potential for biocompatibility and biodegradability, along with the ability to customize depending on the medical application.

“Now as the technology advances; in near future 5D printed ODF might be possible too. 5D printing is another new part of additive manufacture. It differs from 3D printing in a way that its print head has the ability to move 5 degrees,” states the author in conclusion. “It also enables to produce bended layers. So, the problems with 3D printed medicine might be overcome with the 5D printing technology in the near future. This innovation might be able to satisfy this essential prerequisite. In this way there is a lesser requirement of crude material when contrasted with 3D printing for making inserts of a similar quality.”

“4D, 5D printing can give more useful results in drug testing, as we’ll be able to print models that reproduce aspects of human organs, such as heart muscles or parts of the liver. This is important, because even promising animal tests don’t guarantee a drug fit for human use.”

What do you think of this news? Let us know your thoughts; join the discussion of this and other 3D printing topics at 3DPrintBoard.com.

Source / Images: ‘Possibilities of 3D & 4D printing technologies for personalized medicine’]

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Interview with Wei Jian Goh of Craft Health on Personalized Medicine and Nutrition

Wei Jian Goh’s startup Craft Health makes personalized medicine and nutrition possible. The startup is one I’m very envious of as I’ve had a lot of ideas in this area for years. Ideas are nothing however and the Singapore based Craft Health team is executing on a series of innovations that could make personalized nutrition and medicine more accessible and widespread. Craft Health is taking a very straightforward and logical idea to market: one pill does not fit all. If we’re both adults and we take a painkiller we may each take one, as prescribed. But I may be twice as heavy as you or my body could have a completely different in many different ways. Craft Health wants to enable the customization of pills and doses to the individual. What’s more the company wants to make their custom 3D printed pills commonplace. On top of that, the team have spotted a huge application which no one is working on in 3D printing: 3D printed nutrition and supplements. Craft Health is a very exciting startup to me that could really unlock many exciting outcomes for people in all sorts of scenarios. I love that it was started by pharmacists to enable them to better help patients. I’m very bullish on the Singaporean startup so we interviewed Wei Jian Goh who is a co-founder and the CEO of the startup.

What is Craft Health? 

Craft Health is a personalized nutrition and medicines platform, leveraging onto 3D printing technologies. Our vision is to simplify the process of pill taking for consumers or patients.

Where do you hope to be in five years?

We aim to be at the forefront of the intersection for 3D printing technologies and formulations, supplying the Craft Health solutions to both nutraceuticals and pharmaceutical industries.

CraftHealth’s CO-Founders, both Pharmacists, Wei Jiang Goh and Seng Han Lim.

 What do you do? 

Using 3D printing, we are able to print different shapes, layers or geometries to provide accurate dosing of active ingredients such as nutraceuticals or active pharmaceutical ingredients. We also compartmentalize individual active ingredients to reduce the risk of cross contamination or interactions. .

At the same time, we are also formulation scientists and have formulated different bases for various controlled release profiles.

These include immediate release (active ingredients are released within 10 minutes of consumption), sustained release (active ingredients are slowly released between 4-6 hours after consumption), amongst others.

We are also developing our very own 3D printer, using the paste extrusion technique where no heat nor UV curing is used. We are looking at how we can automate the 3D printing process in a scalable manner.

In short, we are able to personalize the nutrition or medicines to the consumer/patient.

How does it work?

Craft Health uses a proprietary blend of generally regarded as safe (GRAS) materials that are already found in the pills that are commercially available. We take the non-active ingredients of these pills and change their ratio in order to achieve different formulations of controlled release. For example, we have formulations for immediate release (release of active ingredients within 10 minutes after consumptions) and sustained release (release of active ingredients slowly over a period of 4 -6 hours). The active ingredient is blended into our proprietary formulations.

The active ingredients and our proprietary formulation for the selected release profile are blended and formed into a paste. The semi-solid paste is then extruded into the shape of a pill using a 3D printer. We are able to print multiple active ingredients, each with their selected release profiles, within the same pill in this way.

What would determine the individual supplements? 

The individual supplements would be determined by the individual, on the basis of what they want (self-selection) and what they need (depending on their response for nutritional questionnaires and even nutrigenomics)

Would it depend on me, or me at one point, my blood work? 

This would depend largely on the extent of personalization you require, from filling up a simple questionnaire to nutrigenomics.

Who are your customers? 

Craft Health is targeting nutraceuticals and pharmaceutical companies to

1. License our technologies and 3D printed formulation solutions

2. Supply our 3D printed pills through the Craft Health Platform

What benefits would they have?

Nutraceuticals: Increase the product range to consumers, especially discerning consumers who are increasingly concerned about what supplements they take. Supplements can be in various combinations personalized to the individual, and also release profiles.

Pharmaceuticals: Rapid prototyping for reformulation exercise to extend existing patent life spans of therapeutics, or a low volume, high mix approach to clinical trials where small volumes batches and dosing can be titrated quickly, depending on the trial results.

Why did you start this company? 

Craft Health is founded by two Singaporean pharmacists, who went on to pursue our PhDs in 3D printing and formulation work.

When we were practising as pharmacists, we saw many instances where patients go home with bags of medicines, typically from common conditions such as hypertension, diabetes and high cholesterol. This is further exacerbated by complicated dosing regimens such as before/after food requirements. We thought that there should be a better solution to this, something that can simplify the process of medicine taking and this, was the inspiration for Craft Health.

Who has funded you? 

Craft Health has recently closed their seed fund raising round led by Mistletoe Singapore, and participated by National University of Singapore (NUS) Graduate Research Innovation Programme (GRIP) and one angel, NUS Adjunct Associate Professor Neo Kok Beng.

What does it feel like to be the first company in 3D printed nutrition? 

We believe we are the first company in 3D printed nutrition in South East Asia. It is a humbling experience as we learn about the various nuances of consumer preferences in this region.

Do you think that 3D printed nutrition is for everyone? or just a select group of athletes? 

We believe the early adopters will be those that require highly specialized nutrition. These include athletes where age, gender, sports type and even the stage of training matters. Eventually we see 3D printed nutrition for everyone, whether for maintaining good health or to optimize their performance.

When do you hope to launch a customer? 

We are an early stage start up, having incorporated in May 2019. Currently we are in the research and development phase, where we are expanding our database of various formulations, developing our in-house 3D printer and also actively looking for collaborations and partnerships. Our target launch for our initial pilot for 3D printed supplements would be late 2020.

What magical sauce do you have that would stop me from copying you?

We believe we are one of the few companies that are developing the complete supply chain for 3D printed healthcare: From developing our very own 3D printers specializing in 3D printing nutraceuticals and pharmaceuticals, to developing our proprietary database of various formulations for controlled release of different active ingredients, whether supplements or pharmaceuticals. Therefore, we are able to offer a one stop solution for 3D printed healthcare.

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The post Interview with Wei Jian Goh of Craft Health on Personalized Medicine and Nutrition appeared first on 3DPrint.com | The Voice of 3D Printing / Additive Manufacturing.

Added Scientific Used Xaar Printhead in Pilot Project for 3D Printing Personalized Pharmaceuticals

Cambridge-based company Xaar may have had its start in developing piezoelectric, drop-on-demand industrial printheads, but transitioned to the 3D printing world back in 2014 when it helped develop the high speed sintering (HSS) FACTUM 3D printer. Xaar is also a leading developer of digital inkjet printing technology, and is currently helping research organization Added Scientific, headquartered in Nottingham, as it works to determine how suitable inkjet printing is in fabricating personalized pharmaceuticals.

Added Scientific, a spinoff company from the University of Nottingham, is using Xaar’s 1201 printhead to bring personalized medicine, with dosages tailored to individual people on an industrial scale, just one step closer to reality.

Craig Sturgess, Research Manager for Added Scientific, said, “Inkjet printing offers the ability to digitally control the printing with its precision placement of tiny droplets a few picolitres in size and the capability to place multiple materials to create complex multi-functional objects in 2D & 3D.

The project was initiated by Added Scientific with its collaborating partners Xaar and global pharmaceutical company AstraZeneca and funded under the UK government’s Industrial Strategy Challenge Fund’s Medicines Manufacturing Challenge, with additional support from Innovate UK. They’re building on research previously conducted at the university regarding the development of excipients: everything but the active pharmaceutical ingredient (API). This pilot project is looking at the long-term suitability and scalability of using inkjet printing to dispense APIs.

“Trial research carried out previously has shown that inkjet offers a real potential for printed medicines. This project was designed to answer questions pharmaceutical companies have around the suitability of inkjet printing in dispensing APIs at a scale that made both manufacturing and economic sense,” Sturgess continued.

The project partners used the Xaar 1201 printhead with one of the university’s formulations to evaluate its impact on the API, in addition to how well it can operate under Good Manufacturing Practice (GMP) conditions. GMP is the de facto standard for manufacturing in the pharmaceutical industry. They also studied if the formulation had an effect on the life of the printhead, and rounded out their experimental trials by evaluating AstraZeneca’s data from conventional tablet manufacturing against inkjet printing process times.

Xaar’s 1201 printhead

“The Xaar 1201 is ideal for a wide range of industrial applications including Advanced Manufacturing due to its ability to print fluids with a range of viscosities, reactivity and conductivity. This pilot project has demonstrated the Xaar 1201’s versatility for pharmaceuticals and how inkjet printing is proving itself to have the potential to drive innovation as well as efficiencies in many areas of 21 st century life,” stated Mike Seal, Business Development Manager, Advanced Manufacturing, at Xaar.

The results from the team’s project showed significant time saved in unit process times from inkjet printing in comparison to conventional manufacturing methods. Production trials consisted of 1,000 dosage forms printed in batches of 100, and no issues or interaction with the API occurred in Xaar’s 1201 printhead; additionally, there was no impact on the life of the printhead itself.

“These are exciting times. Our project has clearly shown that printing personalised medicines – with all their advantages of dose and design freedom – is no longer just a theory, but a scalable and economic reality for pharmaceutical companies and we look forward to extended trials to confirm these findings,” Sturgess concluded.

Added Scientific and its project partners are certainly not the first to investigate the idea of using 3D printing to fabricate personalized medication, and I doubt they will be the last. However, inkjet printing is not typically used to make 3D printed medication, so it will be interesting to see what the team’s next steps will be.

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[Images: Xaar]

Hebrew University and Yissum Developing Novel Technology Platform for 3D Printing Personalized Medicine

Yissum, which is the Hebrew University of Jerusalem‘s technology transfer company and handles the patenting and commercialization of any inventions produced there, has had a hand in many unique 3D printing innovations, such as Nano Dimension’s conductive nano-inks and a process to generate hybrid machine elements. Last year, the company, which was founded in 1964 and has licensed over 900 technologies and registered over 10,000 patents covering 2,800 inventions, introduced a novel technology platform for 3D printing personalized food, and has now moved on to 3D printing personalized medicine.

The company, which is only the third of its kind, builds a bridge between academic research and its worldwide community of entrepreneurs, investors, and industry. It’s responsible for spinning more than 135 total companies. Yissum recently announced a novel technology platform for fabricating 3D printed drug capsules, and presented it today at the university’s 2nd annual 3D Printing and Beyond conference, which is sponsored by Yissum, the university, and the Jerusalem Development Authority.

Professor Shlomo Magdassi, head of the university’s 3D and Functional Printing Center and a member of the Center for Nanoscience and Nanotechnology and Institute of Chemistry, worked with Dr. Ofra Benny, a researcher at the university’s Institute for Drug Research, to develop the innovative drug 3D printing technology platform.

“Professor Magdassi and Dr. Benny’s research is an excellent example of the  kind of interdisciplinary transformational inventions that originate  from the Hebrew University,” said Dr. Yaron Daniely, CEO and President of Yissum. “This technology is bringing us closer to a future in which the medical field can offer personalized, patient-centered care.”

The technology is based on custom 3D printed hydrogels with delayed release characteristics, and allows for a complex design of drug delivery systems that is not currently available in the more traditional pharmaceutical manufacturing techniques.

Dr. Magdassi already has plenty of experience with 3D printed hydrogels and other unique 3D printable materials. 3D hydrogels are hydrophilic polymeric networks that are cross-linked by either chemical covalent bonds, physical interactions, or a combination. Because of these crosslinks between polymer chains and their hydrophilic nature, hydrogels can actually swell up to a hundred times, or even a thousand, of their dried mass without needing to be dissolved in water, and they are an ideal material for biomedical applications.

Yissum’s company mission is to take transformational technologies and innovations and convert them into commercial solutions that address the most urgent challenges in our world, in order to benefit society. I’d say this new 3D printing platform fits the bill – the approach makes it possible to 3D print customized medications out of hydrogel objects that can change shape, expand, and even activate on a delayed schedule.

The novel new 3D printing platform can not only achieve complex release profiles and structures of drugs, but it can also personalize prescription medicines, so doctors can more accurately tailor the dosage levels and exposure of medications for different patients. Thanks to 3D printing, medication may not have to be one-size-fits-all.

Professor Magdassi and Dr. Benny presented their work at the 3D Printing and Beyond conference today, which Professor Magdassi helps organize with Dr. Michael Layani. The conference brings together a range of researchers and industry leaders from around the world to discuss and learn more about the latest advances in defense-related technologies, electronics, and pharmaceuticals, in addition to 3D printed innovations like automotive parts and food.

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