The Business of Biofabrication

The Wake Forest Institute for Regenerative Medicine (WFIRM) has secured up to $24.8 million in federal funding over five years to advance one of regenerative medicine’s most ambitious goals: creating fully functional, bioprinted kidneys on demand. The award comes through the Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program of the Advanced Research Projects Agency for Health (ARPA-H).

Building Living, Patient-Specific Kidneys

Led by Anthony Atala, WFIRM’s director and principal investigator, the initiative focuses on producing implantable, vascularized kidney tissue derived from each patient’s own cells. These tissues are combined with advanced bioinks designed to support long-term viability and functional integration.

“This project demonstrates how tissue engineering can be coupled with bioprinting to create a positive disruption to patient care,” Atala noted in the program announcement, emphasizing the vision of an “inexhaustible pipeline” of autologous organs.

Co-principal investigator James Yoo highlighted the project’s systems-level approach. The team is integrating cell manufacturing, multi-material bioprinting, bioink formulation, and bioreactor maturation into a unified workflow capable of producing clinical-grade kidney tissue.

A Convergent Manufacturing Platform

Central to the effort is the development of an end-to-end biomanufacturing platform that brings together:

• Scalable cell expansion and differentiation
• Multi-nozzle and multimaterial bioprinting
• Perfusion-enabled bioreactors for tissue maturation
• Quality systems for regulatory compliance

This integrated model reflects ARPA-H’s emphasis on translating laboratory breakthroughs into deployable clinical technologies.

According to Ryan Spitler, PRINT’s program manager, success will require “major breakthroughs in cell manufacturing, bioreactor design, and 3D printing technology.” If achieved, the program could redefine how organs are produced and delivered to patients.

Rice University and Advanced Bioink Development

A major component of the project is being led by researchers at Rice University, under the direction of Antonios Mikos, a leader in biomaterials and tissue engineering.

The Rice team is developing a library of adaptive bioinks capable of supporting multiple renal cell types while mimicking the kidney’s complex microenvironment. These materials must be printable, biocompatible, mechanically stable, and capable of sustaining cells during pre-implantation culture.

Postdoctoral researcher Vasiliki Kolliopoulos, working in the Mikos lab, emphasized that these inks are among the most technically demanding elements of the project, requiring precise control over biochemical and physical properties.

A Multi-Institutional Collaboration

Beyond WFIRM and Rice, the program brings together a network of academic and industry partners, including:

• University of Maryland
• PrintBio Inc.
• University of Texas at El Paso

This collaborative structure reflects the “convergent science” model increasingly favored in large-scale biofabrication initiatives, where materials science, cell biology, mechanical engineering, and manufacturing must evolve in parallel.

Toward Scalable Organ Manufacturing

In addition to scientific development, WFIRM is tasked with creating a commercialization and scale-up strategy. This includes planning for:

• GMP-compliant manufacturing facilities
• Automated bioprinting and maturation systems
• Supply chain and quality management infrastructure
• Regulatory pathways for personalized implants

The goal is not only to demonstrate technical feasibility, but to establish a viable pathway for routine clinical deployment.

Redefining the Future of Kidney Care

Chronic kidney disease and end-stage renal failure continue to impose immense physical, emotional, and economic burdens on patients and healthcare systems. Current transplants are limited by donor availability, immune rejection, and finite graft lifespans.

By enabling the production of vascularized, patient-specific kidney tissue, WFIRM’s ARPA-H–supported program represents a major step toward regenerative alternatives that could reduce transplant dependency and improve long-term outcomes.

If successful, this platform may serve as a foundation for future bioprinted therapies targeting other solid organs, positioning WFIRM at the forefront of a new era in regenerative medicine—where organs are built on demand, tailored to each patient, and delivered at scale.