2014 Speaker Interview – Keith Murphy
Exploring the potential for 3D bio-printing in the biomanufacturing industry
We conducted an exclusive interview with Keith Murphy, Chairman and CEO at Organovo ahead of his spotlight appearance at the 6th Annual Biomanufacturing Summit 2014. Organovo uses using 3D bio-printing technology for developing a range of tissue and disease models. Mr. Murphy is one of the foremost leaders in regenerative medicine and 3D bio-printing.
Find out what he had to say here.
The industry in general is working at an operational level that can be described as small size, low volume, and with simple designs compared to what is possible. Room for growth exists along each of these continuums. The goal to build larger tissue structures, especially for potential therapeutic applications is well recognized. This will require solving problems related to handling and viability in the construction and maturation process. All tissues differ in some way, from being rather straightforward with only a few cell types to being quite sophisticated with numerous cell types and sub-structures forming the full tissue. Being able to engineer more intricate designs remains an area to be advanced. Tissue production scaled at a manufacturing level, to efficiently and consistently produce a tissue design for repeat applications such as in medical research and drug discovery will be increasingly important to satisfy a rapidly growing demand for these high value testing models.
What research and technology are still needed to push these areas forward?
One main area to be advanced includes developing the automation and throughput capabilities in making tissues at an expanding and repetitive scale. This need serves both cost and quality, in minimizing labor, reducing loss of valuable cellular inputs, and enabling a process that can consistently build the same tissue time and again free of human factors that can introduce random error. A second area is in developing a means to expand the mass/volume build size for tissues. This requirement is centered on the ability to nourish a growing tissue through the incorporation of a vascular and capillary system. Having this sub-system provides the necessary design element to expand on the repeating patterns and architecture commonly found in various tissues.
What excites you the most about Organovo and the future of the company?
We are most excited about our positioning to contribute to solving significant medical and medical research problems. Because our technology platform is both universal and automated, we have the means to advance both the design challenges and the fabrication challenges. As a company with engineering expertise, we are working to scale up our instrumentation and automation capabilities in anticipation of the need for a consistent supply of ready-to-use tissues in a repeating demand model. As a company with cell biology expertise, we are capable of bringing the right cell inputs together with increasing levels of design complexity, and have shown early success in capillary formation in tissues, and blood vessel development for vascularization.
When did you develop and implement a quality system relative to corporate development?
We are in the process of developing a quality system with the establishment of a disciplined development process that results in documentation to support manufacturing transfer, verification and validation, routine testing and production release, supplier quality, vendor qualification and materials acceptance criteria. The implementation of this system is paralleling the development and release of our first commercial product in 2014, a human liver tissue model.
Will this be an “individualized therapy” or a generic approach?
The design and development of any therapeutic will be guided by unmet medical need, best forms of administration, and optimized patient outcome. There are cases where the best approach would be autologous such as in certain types of bone marrow transplants, and others will be allogeneic, especially when rapid medical intervention delivers the best clinical results. Our technology has the potential to be used long term to determine individualized drug therapies, for example by testing several drug treatment regimens on bioprinted tumor structures made directly from patient biopsied cells.
What are the anticipated treatment costs per patient?
Cost per patient will vary due to a variety of factors including the targeted indication, design and complexity of the tissue therapy, the method of administration, the approach for developing a specific therapy; autologous vs. allogeneic, and the like. The ultimate goal in regenerative medicine, implied in its name, is to develop and deliver curative medical alternatives for conditions that are or can become long-term health management costs to the system with corresponding implications to a patients quality of life. The fair value of these regenerative solutions must be viewed in the context of medical economics and the patients well-being as a contributing member of society.