BioProcess Insider contributor Gareth Macdonald explores one of the stories that came out of the event.
Regeneron says rapid response technologies pioneered to combat Ebola are helping accelerate efforts to create COVID-19 countermeasures.
Last week Regeneron won US FDA approval for Inmazeb (atoltivimab, maftivimab and odesivimab-), its treatment for Zaire Ebola.
The product is made from three monoclonal antibodies that target the Ebola glycoprotein, preventing the virus binding and infecting cells.
Regeneron created Inmazeb using the same rapid response manufacturing platform it is currently using for RGEN-COV2, its COVID-19 treatment candidate.
Shawn Lawrence, senior director, cell culture, preclinical manufacturing and process development, told the Bioprocess International (BPI) virtual conference last month that Regeneron’s VelociSuite technologies helped accelerate the Inmazeb.
“VelociSuite allows generation of fully human monoclonal antibodies on timeline compatible with fighting infectious disease outbreaks.”
From immunization of the target Ebola glycoprotein into Velocimmune mice through antibody selection to the creation of cell lines expressing the Inmazeb antibodies took 76 days Lawrence said.
He likened the project to Regeneron’s work on the pandemic, explaining “The rapid response paradigm was critical for developing an Ebola treatment, but the obvious infectious disease concern currently is COVID-19.”
Regeneron released the first data from a descriptive analysis of a Phase I/II/III trial of RGEN-COV2 in September.
According to the firm the data show the mAb cocktail reduces viral load and shortens the time to alleviate symptoms in non-hospitalized patients with COVID-19.
Regeneron has been gearing up to make commercial quantities of RGEN-COV2 for months and has earmarked capacity at its 130-acre site in Rensselaer, New York.
In May, the firm said it had cleared capacity at the plant to allow it to begin making the product as soon as possible.
At the time CEO Leonard Schleifer said, “We have been working to clear manufacturing capacity in our New York plant so that we can make it at large scale.
“We hope to be able to have a couple hundred thousand doses by the end of the summer and then continue to manufacture from there. In terms of pricing, donations, and fair values and all that sort of stuff that’s just got to come down the road a little bit.”
