Regeneron confident it can scale-up to meet US COVID MAb demands

Regeneron has entered an agreement worth $2.625 billion with the US government and believes it can supply 1.25 million additional doses of its monoclonal antibody cocktail for COVID-19.  

The US Department of Health and Human Services (HHS)and the Department of Defense (DOD) will purchase finished doses of the antibody cocktail, REGN-COV2, a combination of casirivimab and imdevimab by June as part of Operation Warp Speed (OWS).

The new agreement comes after the Biomedical Advanced Research and Development Authority (BARDA)  granted Regeneron a $450 million contract to manufacture and distribute up to 300,000 doses of REGN-COV2 back in July.

Image: iStock/Cristian Storto Fotografia

To meet the government demand of an additional 1.25 million doses by the end of June, the firm has had to make various changes in how it operates.

​The production of monoclonal antibodies is “a complex, time- and labor-intensive process,” a spokesperson for Regeneron told Bioprocess Insider, adding “since the early days of the pandemic, Regeneron rapidly scaled up production utilizing production and manufacturing platforms we developed over decades. We have already adjusted much of our internal manufacturing activities to maximize our ability to produce the cocktail.”

Aims of 2 million doses

Last August Regeneron announced a partnership with Roche, aiming to develop and manufacture the antiviral antibody combination which, if approved, will treat non-hospitalized COVID-19 patients.

The partnership hopes to increase the overall capacity of REGN-COV2 “by at least three and a half times,” with Regeneron telling us “We currently anticipate that the full supply for this agreement will be produced by Regeneron, we have also significantly increased global capacity through our collaboration with Roche.”

In addition to this, Regeneron has already cleared capacity at its site in Rensselaer, New York by shifting manufacturing to its site in Limerick, Ireland.

“In response to the needs of COVID-19, we worked with regulatory authorities to accelerate licensing of our Irish facility to manufacture our full portfolio of commercial products, in order to enable the US manufacturing site to maximize production of our antibody cocktail.”

To further maximize capacity, Regeneron is conducting whether it is safe and efficient to lower the authorized dose for emergency use from 2,400 mg to 1,200 mg. If successful, under this agreement, the government will acquire the lowest authorized dose meaning that there is potential to produce a higher quantity.

“Collectively, we now expect to be able to produce more than 2 million treatment doses per year, and if data supports use of a lower dose of the cocktail this figure would increase accordingly,” Regeneron told us.