Lincoln – The development of a recombinant protein for use as a compassionate-care treatment for coronavirus patients is underway at the Biological Process Development Facility in the University of Nebraska–Lincoln’s College of Engineering.

The facility is working with a pre-clinical drug discovery company, using its proprietary genetic technology platform to produce a recombinant protein as a biotherapeutic for COVID-19 patients who may have few options left for treatment. According to Dennis Hensen, project manager, clinical trials for the treatment are being fast-tracked for a possible July start.

The facility, located in Othmer Hall on the UNL’s City Campus, specializes in process development and good manufacturing practices for the production of recombinant peptides and proteins that are suitable for non-clinical and clinical studies. The facility develops compliant manufacturing processes and test methods used in the production of drugs and other biologics, and it produces bulk drug substances under practices that are suitable for non-clinical and clinical trials. The facility also produces bulk intermediates for further processing and industrial enzymes for manufacturing.

“The protein we’re producing will be used to provide a treatment option for people with advanced cases to hopefully prevent the need (for) or reduce the time on a ventilator,” said Scott Johnson, production manager, who emphasized the treatment isn’t a vaccine candidate.

Biological Process Development Facility researchers were already conducting development work with the protein when the company determined that it could have potential use in treating the effects of the coronavirus, Hensen said.

Johnson said that about 20 scientists and technical professionals, including some students, are working on the project. Due to the complexity of the work and strict guidelines for producing GMP materials, the facility already has extensive cleaning and safety protocols in place but will introduce further safety measures for employees during the COVID-19 response, he said.

According to Cory Smathers, business operations manager, the facility has other COVID-19-related projects in early development. One involves creating a working group with a large biopharmaceutical company and several universities to develop a potential vaccine for the coronavirus; a second would produce components to support diagnostic kits.

UNL Engineering Also Working on Vaccine

Lincoln – The University of Nebraska–Lincoln’s College of Engineering’s Biological Process Development Facility is working with an emerging biotechnology company on a vaccine that could treat patients who have the novel coronavirus and help prevent similar outbreaks in the future.

The vaccine being developed by Vault Pharma, headquartered at the California NanoSystems Institute’s Magnify incubator at the University of California, Los Angeles, could be a complementary weapon to any initial vaccine for COVID-19 treatment.

Vault Pharma creates genetically modified versions of vaults – naturally occurring nanoparticles found in every human cell — as a delivery device for potential therapies or vaccines. The barrel-shaped vaults include a shell of 78 copies of a particular protein, housing two additional proteins and some genetic material.

A vault-based strategy could be well-suited to fight the novel coronavirus by preventing infection and activating the humoral immune system, which uses antibodies to neutralize foreign microbes in bodily fluids and tag them for elimination by immune cells.

“The nature of these nanoparticles suggests they could be readily internalized by multiple immune cells to respond to the novel coronavirus,” said Scott Johnson, production manager for the Biological Process Development Facility. “The BPDF would transfer in the production process, potentially optimize specific steps to increase purity and yield, and scale up the process to produce material for clinical testing.”

The UNL-based research facility has plenty of experience and expertise in these areas, including collaborating in 2015 with the U.S. Army Medical Research Institute of Infectious Diseases to produce material for clinical trials on a ricin vaccine.