The R&D Tax Credit Aspects of 3D Bioprinting



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        We already expected 3D printing to change the face of manufacturing. Its revolutionary impact on medicine, however, is undeniably surprising. 3D bioprinting combines additive manufacturing techniques and groundbreaking biomedical research. The results could have come from a sci-fi movie.

        Recent developments have shed light on the huge potential of 3D bioprinting. Even though significant challenges remain, the multiplication of R&D efforts gives us reason to believe that the futuristic notion  of 'bionics' may not be as distant as it seemed. Federal R&D tax credits are available to support companies investing in eligible 3D bioprinting innovation activities.


The Research & Development Tax Credit

        Enacted in 1981, the Federal Research and Development (R&D) Tax Credit allows a credit of up to 13 percent of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:

  • New or improved products, processes, or software
  • Technological in nature
  • Elimination of uncertainty
  • Process of experimentation


        Eligible costs include employee wages, cost of supplies, cost of testing, contract research expenses, and costs associated with developing a patent. On January 2, 2013, President Obama signed the bill extending the R&D Tax Credit for 2012 and 2013 tax years.


3D Bioprinting

        3D printing, or additive manufacturing, is the process of building three-dimensional objects from digital models. This is achieved through an additive technique, which consists in superposing successive layers of material. This process is clearly distinguishable from traditional machining techniques, which largely rely on subtractive methods, and, therefore, consists in a major transformation of manufacturing practices.

        For a while, 3D printing has been applied to medical challenges. Using materials such as ceramics , porcelain, acrylic, and polymers, engineers have been able to print bone grafts, dental crowns, hearing aids, and different sorts of prosthesis. 3D bioprinting, however, takes the symbiotic relationship between medicine and technology to a whole new level.

        While 3D bioprinting follows the usual additive manufacturing logic, it relies on a very unique material. More precisely, it contains in the ability to print with living cells.

        Needless to say, such ability can revolutionize medicine. For decades, tissue engineers had tried to build replacement organs. However, the traditional method of manually delivering cells has proved inadequate for the task. Not only was it arduous and time-consuming, but it also limited the complexity of tissues, making it impossible to replicate original structures.

        3D bioprinters completely modified this scenario, as they allow for more efficiency and complexity. Potential applications are numerous and include the creation of cellular tissues for drug testing and medical training, and the development of transplantable organs, not to mention bionic ones.


3D Bioprinting Research & Development

        In recent years, 3D bioprinting has been the object of mounting investments and of a considerable number of R&D efforts. The National Heart, Lung, and Blood Institute, for instance, has awarded $600,000 in grants to bioprinting projects since 2007. As a result, we have seen important advances that open the way to innovative applications of 3D bioprinting. The development of more complex printers, the adaptation of design software, and the progress of regenerative medicine have been particularly important.

        However, major challenges remain. Being able to print with living cells doesn't mean that the resulting tissues will behave like real ones. Printed tissues normally rely on artificial scaffolds for mechanical stability and for the delivery of growth factors and genes. Scaffolds are usually made from biodegradable polymers, which can introduce foreign material into the body and cause inflammation. Moreover, it is difficult to predict how different cell types will respond to scaffold materials which can be challenging, particularly in the case of complex organs.

        Even projects that work exclusively with human tissue - and rely on the fusion of cellular aggregates - face obstacles. Building a vascular network for bioprinted organs is one of them. Blood vessels provide nutrients and oxygen, without which no organ can thrive.

        Finally, existing software remain inadequate for the complexity of 3D bioprinting projects. In the words of Cornell engineer Hod Lipson, co-author of Fabricated: The New World of 3D Printing, "You can't have a software model of a liver. It's more complicated than a model for a jet plane."

        Companies investing in R&D activities aimed at overcoming any of the previously described challenges may be entitled to significant Federal R&D tax credits. The following sections will present a brief overview of on-going R&D efforts both in the academic and corporate worlds.


University Efforts

Major U.S. research universities are engaged in a wide range of 3D bioprinting R&D activities, as summarized below:

Cornell University: Bioengineers from Cornell University have successfully built a facsimile of a human ear that looks and acts like a natural one. The process consists in printing a seven-part mold and injecting it with bovine cartilage and collagen from rat tails, which serves as scaffold. Several days in cell culture guarantee the propagation of cartilage, which eventually replaces the collagen. This achievement is revolutionary for children born with underdeveloped or malformed outer ears.

Wake Forest University: Researchers from the Wake Forest Institute for Regenerative Medicine are developing bioprinted kidneys. The idea is to use a 3D bioprinter to simultaneously deposit kidney cells and build a biodegradable scaffold. After incubated and transplanted into a patient, the organ would grow into complete functionality. If successful, this project would tackle a major public health problem: in the U.S., almost 80% of those on organ-transplant lists are waiting for kidneys.

 When skin grafts are needed, surgeons usually take skin from one area of the body and place it onto the wounded area. Researchers from the Wake Forest Institute for Regenerative Medicine are working on a 3D printer that will hopefully print skin directly into the wound. The objective is to develop a portable device, which could be used in disaster zones.

University of Pennsylvania and MIT: Aimed at facing one of 3D bioprinting's major challenges, researchers have worked on the creation of blood vessels. The ingenious project starts with the printing of a network of sugar filaments inside a mold. After coating the filaments in a polymer, they inject human cells into the mold. Water is then used to dissolve the sugar, opening up empty channels in the tissue. When such channels are filled with nutrients, surrounding cells present higher survivability rates. Despite positive initial results, printing more robust vascular networks remains a challenge.

Washington State University: Researchers from WSU have used additive manufacturing to create a bone-like material. The process consisted of covering a 3D-printed ceramic scaffold with a plastic binder and submitting it to high temperatures. The material was then kept in a culture with immature human bone cells. After a week in this environment, the scaffold was already supporting a network of new bone cells. If successful, this project could eventually allow for the creation of custom grafts for specific fractures.

Princeton University: Using bovine cells, liquid gel, and silver particles, scientists from Princeton University have printed a bionic ear. The silver particles take the form of a spiral antenna, which is sensitive to radio signals. This project aims at exploring the combination of electronics and biology and the possibility of giving humans an "electronic sixth sense".

University of Iowa: Researchers from the University of Iowa have developed a multi-arm 3D bioprinter. This innovative design is expected to speed up the process of achieving printable and transplantable human organs. Different from other bioprinters, which have only one arm, this invention is able to simultaneously lay down multiple materials. This is particularly important for the creation of vascular networks, which can eventually result in more stable organs. The multi-arm 3D bioprinter is already being used in an effort to find the cure for diabetes. The objective is to create a transplantable glucose-sensitive pancreatic organ, which, once implanted in people with diabetes, would be able to regulate the glucose level in the blood.

University of Louisville: In collaboration with the Jewish Heritage Fund for Excellence, researchers from the Cardiovascular Innovation Institute are engaged in the ambitious project of creating a fully functioning, 3D bioprinted human heart. The idea is to use a patient's fat-derived cells to print a "bioficial" heart. Stuart Williams, executive and scientific director of the Cardiovascular Innovation Institute, works with a 10-year timetable for achieving this objective and believes that the 3D bioprinted heart will cost around $100,000.


Corporate 3D Bioprinting R&D

        The wave of academic 3D bioprinting R&D has been followed by important corporate initiatives.

        San Diego-based Organovo Holdings has created a 3D bioprinted, functional liver tissue that replicates the compositional and architectural features of native tissue. The idea is to use such tissues for drug testing and for researching the impact of certain diseases on the liver. The company expects to make its liver assay commercially available by next year.

        Organovo has recently announced a partnership with Autodesk to design a modern, cloud-based bioprinting software. Eventually, the platform is expected to incorporate mathematical formulas that account for the cellular processes involved in bioprinting. Different from nonliving 3D printing, which presents unchanging design, 3D bioprinting must consider dynamic processes such as the self-assembly of stem cells. The creation of specific software is a necessary step in the development and consolidation of 3D bioprinting technology.

        Texas start-up TeVido BioDevices has been engaged in the development of breast tissue for implants using 3D bioprinting technology. In addition to the usual scientific conundrums, the company must face technical challenges, including the necessity for faster and more cost effective processes. TeVido CEO, Laura Bosworth, estimates the company will need around seven more years and $40m of tests before achieving its objective of making bioprinted implants commercially available.


Conclusion

        According to the United Network for Organ Sharing, there are currently more than 119,100 people in the waiting list for organ transplants in the U.S., a number that is constantly growing. 3D bioprinting can completely alter this scenario, becoming a source of hope and health to thousands of people. Grown from a patient's own cells, 3D bioprinted organs will be perfect matches. Difficulties in finding suitable donors will finally be overcome. It will be the end of the persistent shortage of transplantable organs.

        3D bioprinting, however, is still in its early days. Years of research and considerable investments will be necessary before achieving functioning, transplantable 3D bioprinted organs. Federal tax credits can speed up this process by supporting companies engaged in eligible R&D activities.


Article Citation List

   


Authors

Charles R Goulding Attorney/CPA, is the President of R&D Tax Savers.

Andressa Bonafé is a Tax Analyst with R&D Tax Savers.

Charles G Goulding is the Manager of R&D Tax Savers.


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