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 university’s City Campus, specializes in process development and Good Manufacturing Practices (GMP) 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 produces bulk drug substances under GMP that are suitable for non-clinical and clinical trials. The facility also produces bulk intermediates for further processing and industrial enzymes for GMP 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 that the treatment is not 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.