With the right design, materials, and parameters, it’s possible to 3D print almost anything—including functional human tissues, employing a technique called bioprinting.

Bioprinting leverages the strengths of two emerging fields: additive manufacturing and tissue engineering. By using bioink—a biopolymer gel that provides a support structure for seeded cells and growth factors—to construct synthetic human tissues layer by layer, bioprinting may one day potentially be able to generate complete human organs.

The Potential of Bioprinted Synthetic Human Tissues

Current pharmaceutical testing practices confirm the safety and effectiveness of new medications using animal studies—which often turn out not to be replicable in humans. Replacing animal studies with tests using bioprinted synthetic human tissues could be transformative in three big ways:

  1. Safer human trials: Synthetic human tissues would provide a more accurate model of how drugs behave in the human body compared to animal trials, improving safety and effectiveness for those enrolled in clinical trials.
  2. Faster and more focused testing: More accurate tests would let researchers avoid wasting time and money on non-replicable animal trials and focus on drugs more likely to be effective in humans.
  3. An ethical alternative: Bioprinted tissues would also allow researchers to use fewer animals in medical testing, reducing the ethical concerns of pre-clinical studies.

As bioprinting technology grows more sophisticated, it will be possible to generate more and more complex structures, opening a path to creating fully functional tissues or organs that could be used for implants and address major current transplantation challenges:

  • Using synthetic organs to replace or help restore function to damaged organs would enable patients to receive critically needed transplants without having to wait years for a compatible donor. For example, the wait time for kidney transplants is currently 3-5 years.
  • Synthetic organs could reduce complications arising from immune system rejection.

Bioprinting Challenges

Currently, several types of tissues have been successfully bioprinted, including blood vessels, trachea, and cardiac tissue. Additional types of tissue—such as nerve, bone, and skin—have been transplanted into animal hosts, but U.S. Food and Drug Administration (FDA) approval has not yet been granted for similar studies in humans. As researchers work to advance bioprinting technology, they face multiple challenges, including:

  • Support structure design: Ensuring bioprinted scaffolds provide a suitable environment for critical functions like transporting nutrients into cells
  • Long-term viability: Integrating bioprinted objects with patients’ vascular systems to enable sufficient blood supply
  • Repeatability and scalability: Controlling the properties of bioprinters to produce precise, consistent results

How Nexight Helps: Supporting Standards and Strategic Planning

Cutting-edge technologies like bioprinting hold enormous potential to reshape the way that biopharmaceutical testing is carried out and expand options available to patients. However, growth in innovation in many emerging technologies, including additive manufacturing and tissue engineering, can often be slow as companies work individually to solve the same challenges, often without knowledge of one another’s activities or without insight into the most pressing needs of their stakeholders. This growth slowdown can be alleviated using two key tools:

  • Standards: Standards help to make foundational knowledge commonly available to all companies. Organizations that help accelerate standards development in emerging technology areas enable companies to focus their attention on solving unique problems and creating more efficient, effective, and innovative products.
  • Strategic Planning: Organizations that strive to collectively engage with the entire community to set priorities, establish desired outcomes, and align and facilitate technology innovation ensure that more targeted, effective products can be developed and made available more quickly to those that need them most.

Nexight supports several organizations, across varied fields of work, as they utilize standards and strategic planning to address these challenges.

ASTM International

Nexight Group supported ASTM International in launching the Additive Manufacturing Center of Excellence (AM CoE), a unique collaborative partnership among industry, government, and academia. The AM CoE integrates research and development with community-identified standards needs to accelerate the development of targeted additive manufacturing standards that can reduce time to market and increase widespread adoption.

Standards Coordinating Body

We also work with the Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB), an independent convening body that complements existing standards developing organization processes. SCB engages the regenerative medicine community in identifying, prioritizing, and advancing standards needs; coordinates the development of new standards; and educates the community about available standards and their benefits.

Kidney Health Initiative

In addition to helping accelerate the development of the technology itself, it is also critical to have a clear vision for how the standard of care will evolve for patients at each incremental step toward the end-goal of 3D bioprinted organs. In our work with the Kidney Health Initiative, we supported the development of a roadmap that puts patient priorities at the forefront of its strategic vision. The roadmap charts a path from current-generation dialysis treatments, which are financially burdensome and detrimental to quality of life, toward portable or wearable technologies, biohybrid implants, and ultimately synthetic or regenerated kidney replacements.

Looking Forward

Nexight Group continues to identify new ways to support innovation in medicine through technology roadmapping, facilitating productive discussions among experts, and communications and outreach, helping diverse stakeholders make critical connections and align their efforts around the common goal of improving patients’ quality of life.