Author: Katelin Snyder

Ross Dunlap is CEO of Ceres Nanosciences and a member of the George Mason Research Foundation board. Photo provided

Ceres Nanosciences, a Northern Virginia bioscience company spun out of George Mason University that specializes in diagnostic products and workflows, has opened a 12,000-square-foot advanced particle manufacturing plant in Prince William County’s Innovation Park. The new facility increases the manufacturing capacity of Ceres’ Nanotrap® Magnetic Virus Particles, which improve diagnostic testing for viruses like SARS-CoV-2, influenza, and respiratory syncytial virus.

The completion of the new facility also reflects the partnership between Mason and the Prince William County Department of Economic Development (PWCDED).

“The PWCDED has a long-standing relationship with Mason, specifically with the Science and Technology Campus that anchors our bioscience hub in Innovation Park,” said Christina Winn, executive director of PWCDED. “Ceres was the first company to graduate our Science Accelerator, and we are invested in their growth as a leader, collaborator and innovator in our life sciences industry cluster.”

The construction of the facility, which was completed in under four months, was funded by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative to expedite the production and commercialization of diagnostic tests for the SARS-CoV-2, the virus that has become known as COVID-19. Prince William County also supported the swift development of the site.

“We’re immensely grateful for the NIH funding that supported this new facility,” said Ross Dunlap, Ceres Nanosciences CEO. “Not only are we now able to deliver a robust supply of this critical reagent that the industry needs, but the facility also is a major element of Ceres’ long-term growth plan.”

Dunlap and his team have noticed significant gaps in the diagnostics industry and infrastructure in the United States, especially in response to an outbreak. He hopes that because the Nanotrap® Magnetic Virus Particles reduce sample processing time, eliminate the need for special kits, and create cost efficiencies, the technology can be leveraged to respond faster to future pandemics.

The Ceres Nanosciences production team. Photo provided

“It was very fortunate that we had put a lot of energy into developing the technology for viral infections and released a product for it before the pandemic, not even knowing that COVID-19 would come about,” said Dunlap, who serves on the George Mason Research Foundation board. “We were able to rapidly respond and quickly validate our technology for COVID diagnostics, which was done in partnership with Mason.”

The base technology underlying the Nanotrap® particle was created by Mason’s Center for Applied Proteomics and Molecular Medicine (CAPMM), which is led by co-directors Lance Liotta and Emanuel Petricoin. The technology was funded with a series of NIH grants from the NIH lnnovative Molecular Analysis Technologies (IMAT) program.

It was then licensed to Ceres Nanosciences in 2008. Follow-on funding to advance the technology was awarded to the Ceres and Mason team by the NIH, the Center for Innovative Technology, Virginia Catalyst, the Bill and Melinda Gates Foundation and the Department of Defense.

“We are very proud to see that a technology developed under NIH funding at Mason has graduated to a product that is aiding in the fight against COVID-19 and promises to help patients all around the world for many other diseases,” said Alessandra Luchini, associate professor for CAPMM and co-inventor of the Nanotrap®.

With the assistance of Mason researchers, who played a large role in efforts such as testing particles and generating data, the technology evolved into a platform that can be modified and adapted to different applications, such as infectious diseases. For example, in 2015, Mason CAPMM scientists and Ceres Nanosciences demonstrated the use of the Nanotrap® technology for the detection of Lyme disease. Today, the Lyme Borrelia Nanotrap® Antigen Test is offered by Galaxy Diagnostics, a medical laboratory that specializes in tests for flea- and tick-borne pathogens.

“Mason has a lot to offer when it comes to cutting-edge technologies,” said Hina Mehta, director of the Office of Technology Transfer. “We are always looking for the right partners, like Ceres Nanosciences, who can take our research discoveries to commercial-grade products that benefit the public.”

Ceres Nanosciences and Mason have worked together since the company’s genesis. Ceres’ first lab was on Mason’s Science and Technology Campus, and the two organizations have collaborated on numerous research projects.

“Mason has consistently been a resource that we go to when we need extra support and research power,” said Dunlap. “The researchers have a range of backgrounds that we need: from virology to microbiology to proteomics. Their areas of expertise have been critical across a lot of our development programs.”

Dunlap said he and his team, along with continued support from Mason, are eager to help people return to pre-pandemic life.

“Our team is incredibly excited and motivated to come to work every day and produce these particles so that people can go back to work and school,” said Dunlap. “We’re proving why this technology has such value and why it can do so much for public health.”

Mason doctoral student Marissa Howard has worked at the Center for Applied Proteomics and Molecular Medicine (CAPMM) since 2016. Photo by Evan Cantwell/Creative Services

When Marissa Howard first came to George Mason University as an Honors College student and a scholar in the Louis Stokes Alliance for Minority Participation (LSAMP) Program, she was a biology major.

As she began looking for hands-on research experiences, her LSAMP mentor, Volgenau School of Engineering professor Alok Berry, suggested she give bioengineering a try.

“It really clicked for me,” said the Richmond, Virginia, native, and she ended up switching her major to bioengineering.

In her junior year, Howard participated in Mason’s Aspiring Scientists Summer Internship Program (ASSIP). That’s when she met Mason researchers Lance Liotta and Alessandra Luchini. She spent the summer studying the electrical properties of their Nanotrap technology.

“I really loved it,” she said. “I really loved them, and they were excited by the work I was doing and asked me to continue working with them. Since 2016, I’ve been in [the Center for Applied Proteomics and Molecular Medicine (CAPMM)] lab.”

Biosciences PhD student Marissa Howard tests vaccine efficacy in healthy and immunocomprised patients by running a rapid COVID-19 antibody test. Photo by Evan Cantwell/Creative Services

For her senior capstone project in 2016-17, Howard led a team of bioengineering students—Sara Sharif, Sameen Yusuf, and Rohit Madhu—to create a noninvasive urine-based tuberculosis (TB) test called TB Assured, and the invention garnered a lot of attention for the team and many awards.

In addition to winning several Mason awards for being the best project of the year, the team also won the $15,000 prize from the National Institute of Biomedical Imaging and Bioengineering’s Design by Biomedical Undergraduate Teams (DEBUT) challenge to help develop the test further.

TB Assured started as a dipstick test, much like pregnancy tests, that would find biomarkers of TB in urine. In an effort to make the test more sensitive and user friendly, Howard came up with the idea of using a paper origami cup as a next generation urine collection cup for the test instead of a test strip.

The biomarker-harvesting Nanotraps are in a glass wool-like substance embedded in the cup. After use, the cup is emptied, collapsed back into its original flat, two-dimensional form, and can be mailed in an envelope for processing.

“Everything that’s in the urine is captured by the Nanotraps, and you don’t need a centrifuge or other equipment,” said Howard, who completed her bachelor’s degree in bioengineering in 2017. “People loved it. They keep asking when it is going to be available at their local pharmacy.”

Howard is now a doctoral student in biosciences at Mason. During the coronavirus pandemic, Howard was able to get back into the CAPMM lab, but now all the researchers are working on COVID-19-related research.

“We are doing some of the analytical validation studies to help different companies file for FDA approval for their rapid COVID-19 antigen tests,” Howard said. “That’s been really interesting and fun—seeing all these different tests that come in.”

For her dissertation, Howard is focusing on cancer research. She is looking at how cancer exosomes (small, membrane-wrapped packages released by cells) communicate. The findings could help create a new kind of immunotherapy.

“[Looking at the exosomes in a tumor sample] is going to tell you a little bit more information than just the pathology would,” she said. “It’s sort of telling you what that tumor is thinking and how it is communicating to its neighboring cells.”

With completing her PhD still about a year away, Howard is planning a future in a lab, possibly in an academic setting.

“I love the research space and the creative potential that comes with it,” Howard said. “You never know when your next idea is going to pop up.”

COVID-19 antibody research by Lance Liotta and his team has shown the human immune system is better able to fight the virus than initially believed. Photo by Evan Cantwell/Creative Services

George Mason University researchers say their study of COVID-19 antibodies in people previously been infected with the virus reveals the human immune system’s strong ability to fight the virus, even if they showed minimal or no symptoms. Additional early results are showing that the vaccines being rolled out to combat the global pandemic generate a strong immune response. 

Lance Liotta, the co-director, co-founder and medical director of the Center for Applied Proteomics and Molecular Medicine (CAPMM) within Mason’s College of Science, and his colleagues are using an improved COVID-19 antibody test developed as part of a Mason clinical study to measure the body’s response to the vaccine. 

Based on months of study of patients who were naturally infected, Liotta and his team were able to verify that patients’ antibodies lasted longer than initially first believed and that they potentially helped prevent those patients from getting sick again. Early results of those who have been vaccinated have confirmed the shots to be strong boosters to the human immune system’s ability to combat the virus by generating more antibodies that block the virus spike protein tips. Tips of the spikes are the starting point for the virus to enter the patient’s cells. 

“This research offers truth and hope,” Liotta said. “The public is anxious and very worried about the virus. They want to know if the vaccines work. They want to know if the antibodies made by the body after a natural infection or after a vaccine will actively work to fight the virus. If I do get sick, can these antibodies help me? 

“The answer is yes.”  

That welcome revelation could be key in lessening the chance for severe sickness and limiting the spread of the virus. 

“Nevertheless we can’t let down our guard, and we must maintain social distancing and mask wearing practices that has protected our students and staff so well,” said Julie Zobel, Mason’s assistant vice president for Safety, Emergency and Enterprise Risk Management.  

Additionally, the expanded antibody research is providing scientists new clues about devising treatments for COVID-19, Liotta said, because of the many ways each of the different antibodies combat the virus. 

“We are humbled at how good the immune system is at fighting this,” Liotta said. 

Liotta and his team began their initial COVID-19 antibody study at the start of the global pandemic last spring. The testing allows scientists see how the body recognizes and reacts to the virus, particularly important when it comes to asymptomatic cases. 

“[Some of the subject tested] never knew that they had contracted COVID,” Liotta said, “but we can tell by looking at the antibodies that exist in their body. That’s a very important piece of information.” 

Antibodies, which are Y-shaped proteins generated by the immune system’s white blood cells, could prove critical in the fight against COVID-19. They attach to antigens much like a key to a lock to destroy invading germs. Once exposed to the virus, the body creates memory cells that will henceforth recognize the invader and spur the immune system to create antibodies to fight it in the future. So having antibodies to COVID-19 could possibly prevent people from becoming infected with the virus again. 

The aim of COVID-19 vaccinations is to stimulate a similar antibody response that would provide that protection from the virus. Liotta’s team of internationally recognized experts in diagnostic testing includes colleagues Virginia Espina, the research professor who oversees the Center for Applied Proteomics and Molecular Medicine’s CAP/CLIA certified laboratories, and Alessandra Luchini, the associate professor overseeing the development of the laboratory antibody assay in the nanotechnology lab. They will collectively use their expertise in clinical laboratory medicine, biochemistry, bioinformatics, molecular biology and infectious diseases to confirm those antibody responses. 

“Mason has been on the forefront of COVID research,” Espina said. “Since March, we have been working on different aspects of COVID research, and [Mason has been] very responsive to testing and keeping the campus community safe. We have done a wonderful job as a university in being able to keep the university open, prevent layoffs and allow students to come back onto campus.”