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.Â Â
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 afterÂ the Biomedical Advanced Research and Development Authority (BARDA)Â granted Regeneron aÂ $450 million contract to manufacture and distribute up to 300,000 doses of REGN-COV2 back in July.
To meet the government demand of an additional 1.25 million doses by the end of June,Â the firm hasâŻhad to make various changes in how it operates.
âThe production of monoclonal antibodies is âa complex, time- and labor-intensive process,â aÂ spokesperson for Regeneron toldÂ Bioprocess Insider, addingÂ âsince the early days of the pandemic,Â 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.â
Aims of 2 million doses
Last AugustÂ Regeneron announcedÂ a partnershipÂ with Roche, aiming to develop and manufacture the antiviral antibody combination which, if approved, will treat non-hospitalized COVID-19 patients.
The partnershipÂ hopesÂ to increase the overall capacity of REGN-COV2 âby at least three and a half times,âÂ with Regeneron telling usÂ âWe 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.â
âIn 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 theÂ USÂ manufacturing site to maximize production of our antibody cocktail.â
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.
âCollectively, 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,â Regeneron told us.