Playing a Part in Developing COVID-19 Monoclonal Antibodies

Anli Ouyang is amazed at the speed scientists created and produced multiple vaccines and therapeutic options to treat and prevent COVID-19. The fact that so much has been done in a year — far faster than the average time required to develop similar products — has encouraged him about other medical developments in the future, and he's looking forward to seeing graduates of Northwestern Engineering's Master of Biotechnology program (MBP) play a part in that process.  

"There are still so many unknowns in life science, and there are still many unmet medical needs," said Ouyang, senior director of bioprocess R&D and operation at Eli Lilly and Company, and member of the MBP Industrial Advisory Board. "MBP at Northwestern prepares its students to join the exciting journey of bringing new medicines to patients."

Ouyang's role at Lilly gives him a front-row seat to the latest developments in COVID-19 treatment. Lilly worked with AbCellera to discover Bamlanivimab, an anti-COVID19 monoclonal antibody (mAb) from the first American patient who recovered from the virus.

Ouyang is responsible for leading bioproduct process development and clinical trial material manufacturing. That means he also is heavily involved working with Lilly's discovery team to identify molecules with appropriate manufacturability. The team selected the lead molecule for Bamlanivimab, developed the process, made good manufacturing practice material, and dosed the patients in a record speed, Ouyang said.

In early November 2020, Bamlanivimab became the first anti-COVID19 antibody to receive Emergency Use Authorization (EUA) approval from the U.S. Food and Drug Administration (FDA) in early November 2020. Since then, hundreds of thousands of doses have been distributed to hospitals all over the country and helped countless COVID-19 patients. Lilly also received EUA approval from the FDA for Baricitinib, a pill intended to be used in combination with remdesivir to help hospitalized COVID-19 patients. 

In addition to the research component mentioned above, Ouyang is involved with developing processes for clinical trials, working with commercial manufacturers, and communicating with regulatory affairs in advance of a clinical trial or commercial launch. The job requires a varied skill set, something he sees being emphasized in MBP. He thinks that training, along with the improved perception of biotech companies as they continue to help combat COVID-19, will set MBP graduates up for success as they become the next generation of researchers and biotechnologists. 

"Pharma and biotech companies are helping society fight this pandemic," he said. "With antibodies, vaccines, and other effective treatment options available, people can start to think about experiencing 'normal life' again."