SBI Selected by the University of Virginia’s Dr. George Christ as a Partner for New Coulter Translational Research Partnership-Funded Project

Scientific Bioprocessing, Inc. (SBI) announced today that it is partnering with Dr. George Christ, Professor of Biomedical Engineering and Orthopaedic Surgery, Mary Muilenburg Stamp Professor of Orthopaedic Research, Director of Basic and Translational Research in Orthopaedic Surgery and Fellow of AIMBE at the University of Virginia, on a new Coulter Translational Research Partnership (Coulter) funded project.

SBI will provide optical sensors that monitor oxygen and pH levels for the new project and lend its sensing expertise to the Christ Lab, which is collaborating with Dr. A. Bobby Chhabra, Lillian T. Pratt Distinguished Professor and chair of the Department of Orthopedic Surgery at the UVA School of Medicine. Christ’s and Chhabra’s Coulter grant translational research project is focused on quality control and assessing the physiological status of the progenitor cells that the Christ Lab uses to make tissue constructs. The project will explore defining the ideal oxygen and pH requirements in a manufacturing environment to better guide product development.

“When I first contacted John Moore at SBI he was really excited about participating in the project. This is a gateway for SBI to showcase the value of their optical sensors in a project that is far along the clinical path,” stated Dr. Christ.

“We are thrilled to be working with Dr. Christ and his team on this important project. This work has the potential to fundamentally change for the better the way cell culture is done, ultimately augmenting quality control and improving tissue engineering product success rates and approvals. In the end, this is about delivering life-changing therapies for those with tissue loss due to congenital defects like cleft lip or traumatic tissue loss injuries suffered by our veterans,” stated SBI’s President John Moore.

The Laboratory of Regenerative Therapeutics, or Christ Lab, develops regenerative medicine and tissue engineering technologies, with a current focus on musculoskeletal tissue engineering and regeneration. The lab is developing a technology platform for the treatment of volumetric muscle loss injuries, which could eventually help the approximately 53,000 veterans that suffer from major tissue loss from traumatic injuries to their head, neck, and extremities. In the funded Coulter project, the intended “first in man” clinical application would be a treatment at UVA for hand trauma, but the technology is also being developed through the Armed Forces Institute for Regenerative Medicine for a “first in man” pilot study as a treatment for secondary revision of cleft lip.

“This exciting work with SBI represents a logical and important extension of our ongoing advanced biomanufacturing efforts at UVA toward development of novel therapeutic solutions for improved functional outcomes from musculoskeletal injuries and conditions. The Department of Orthopaedic Surgery is ready to provide these next generation regenerative technologies to our patients as soon as they are available,” said Dr. Chhabra.

A key to successful biomanufacturing of tissue engineered medical products (TEMPs) is understanding how cells and tissues developed in the lab will need to function within the human body. In other words, what are the most appropriate biomanufacturing conditions required to ensure that the implanted cells are optimized for their intended purpose? Understanding those requirements and accurately monitoring the biomanufacturing process will be critical to reproducibly maximizing clinical outcomes. Work in this area will also leverage the extensive equipment, resources and expertise provided by the UVA Center for Advanced Biomanufacturing.

“As noted in our proposal, we don’t really know what the oxygen status is in the microenvironment of the cells that we culture and apply to our constructs. For any manufacturing process we need to know the critical quality attributes—the attributes that define optimum cell health and function for our intended purpose—that is, how do we gauge how good they are and what kind of boundary conditions do we put on them for ensuring successful implantation and functional outcomes?” said Dr. Christ.

The key to better quality control of TEMPs will be achieved, according to Dr. Christ, through improved monitoring of cellular status during the biomanufacturing process, such as measuring and controlling cells’ oxygen and pH, knowing that in the end they will need to adapt to the physiological conditions in the body.

“There is still very little knowledge in this area of advanced biomanufacturing. It’s a little disconcerting to think that many investigators culture their cells in conditions that aren’t physiologically relevant to their functions in the body. The fact that many cell types are relatively easy to culture now does not provide much incentive for further research and development. However, evidence is accumulating to clearly indicate that there are cell types in culture that more closely approximate their native state in the lower oxygen environments that are found in the body (as compared to a standard cell culture incubator),” stated Dr. Christ.

Historically, according to Dr. Christ, cell culture and bioprocessing has overlooked the importance of how cells grown in a lab will function when they are infused or injected into people. Traditionally, cell culture has focused primarily on research outcomes and not as much on aligning the cell culture biomanufacturing process with the physiological conditions and requirements of the human body. These will be important considerations when approaching the Food and Drug Administration (FDA) with proposed biomanufacturing processes, as well as scaling it down the road.

In fact, now that the FDA is pushing cell and gene therapy developers and tissue engineers for increased uniformity of process, stronger quality control and demonstrable safety and efficacy, monitoring critical cellular parameters, such as oxygen levels during the cell growth/biomanufacturing process, in real time, is more critical than ever. Christ’s lab and SBI are doing the research that could ensure that cells are grown in a way that de-risks tissue implantation and increases the likelihood it will be durable, effective and safe.

SBI’s optical sensor technology, which empowers labs to monitor and report on cell conditions in real time in form factors from small flasks to the largest bioreactors, will be a critical tool for the Christ Lab as it assesses the physiological status of the progenitor cells they use to make tissue constructs.

“What attracted me to SBI’s sensors is that they are totally non-invasive. I don’t have to destroy anything to measure something. You get the best of both worlds: the opportunity for long term, longitudinal analysis of cellular status on the one hand, and on the other, you don’t have to compromise your samples while you do it,” stated Dr. Christ.

“SBI is a forward-thinking, collaborative organization. In my opinion, having SBI and John on board for our proposal was a big plus and helped us secure this grant—due to the added commercialization potential enabled by our collaborator. SBI is also willing to send people to UVA and make design changes to solve a problem and that kind of engagement is really hard to find—but absolutely critical for success. SBI is committed to moving the field forward,” stated Dr. Christ.

SBI has also connected Dr. Christ and his team with other vendors that have helped move the project forward quickly as it approaches its first project report to the Coulter Board on December 9, 2020.

“The partnership between SBI and Drs. Christ and Chhabra perfectly exemplifies the power of the UVA-Coulter Translational Partnership in bringing together collaborators to develop new technologies that address unmet clinical needs, improve health care and lead to commercially available products,” said Frederick H. Epstein, Mac Wade Professor and chair of UVA’s Department of Biomedical Engineering and professor of radiology and medical imaging at the UVA School of Medicine.

“Depending on what we find, this study could be revolutionary in terms of how you biomanufacture TEMPs and monitor key attributes throughout the entire process. If we can crack this nut, you can industrialize this process, costs will go down, and the number of people that can do this goes up. We need to crowdsource this kind of challenge; we need to figure out how we can accelerate biomanufacturing and clinical applications of TEMPs in a cost effective and reproducible fashion, so that we can get next-generation regenerative medicine therapies with improved functional outcomes to the many patients that need them. Moreover, in so doing, we want to standardize critical monitoring technologies for biomanufacturing of TEMPs so that they are more available to everyone and that’s the way it should be,” stated Dr. Christ.

“I applaud SBI for its vision and its commitment to help the field overcome these biomanufacturing challenges,” he added.

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