◼ BUSINESS Bloomberg Businessweek November 2, 202015PHOTOGRAPHS
BY
MARK
SOMMERFELD
FOR
BLOOMBERG
BUSINESSWEEK
That’smisleading.Evenif theU.S.Foodand
DrugAdministrationgivesthego-aheadtomorrow,
everybitofsparecapacitywillbeneeded,andit
stillwon’tbeenough.That’sbecausemonoclonal
antibodies—man-made versions of antibodies the
body produces—are among the most complicated
pharmaceutical products to manufacture, brewed
in live cells over a period of months. They’ve rarely
been made at the mass scale needed for a pandemic.
The antibodies Lilly, Regeneron, AstraZeneca,
and GlaxoSmithKline, with Vir Biotechnology, are
testing are among the most promising categories
of Covid treatments. Infused into the bloodstream
soon after an infection, they may decrease virus lev-
els, lowering the risk for severe complications and
possibly providing a bridge until vaccines are widely
available. And if vaccines prove not to be the silver
bullet public-health officials are hoping for, demand
for antibody treatments could persist indefinitely.
Since Trump’s seemingly successful treatment,
Regeneron’s two-antibody cocktail has captured
the most attention. But Regeneron has just 50,
doses now, and it may have only 300,000 more in
the next few months. Lilly made 100,000 doses of its
drug in October and plans to have 1 million by year-
end. That’s because it decided to conduct tests using
lower doses of a single antibody—called LY-CoV555—
rather than a more complex cocktail. The U.S. gov-
ernment on Oct. 28 agreed to a $375 million deal to
buy 300,000 doses of the Lilly antibody—if the treat-
ment gets the regulatory go-ahead.
Still, even if usage is restricted to high-risk
patients, such as the elderly, there will be big short-
ages. “The bigger problem is the people who will
never be able to get the drugs,” Ricks says. “We’re
going to have a supply problem no matter what.”
Making matters trickier, the Branchburg, N.J.,
plant where Lilly plans to make much of its initial
supply has faced quality-control issues, according
to internal agency documents Bloomberg reviewed.
Employees didn’t investigate potential quality prob-
lems and routinely overrode standard test results,
according to the documents. Lilly says it hasn’t
received a warning letter from U.S. regulators and is
working to resolve the issues, which haven’t affected
the antibody treatment or the pace of production.
The company’s treatment consists of synthetic
copies of an antibody isolated from one of the first
Covid patients in Washington state early this year.
“It’s just like in the movies, where they say we’re
going to find this patient, find something in his
blood, and turn it into a treatment,” says Daniel
Skovronsky, Lilly’s chief scientific officer.
A second antibody Lilly is testing in combination
with LY-CoV555 was derived from a patient in Wuhanand licensed from Shanghai Junshi Biosciences Co.
in May. That cocktail, though possibly more effec-
tive than the single-antibody treatment, won’t be
available as quickly due to the challenge of manu-
facturing it. Lilly plans to request an emergency use
go-ahead for the two-antibody combo in November.
The company started work on an antibody
treatmentinFebruaryafterRicksandSkovronsky
receiveda proposalfromAbCelleraBiologicsInc.,
a smalldrug-discovery shop that had developed a
“lab-on-a-chip” technology to search blood samples
for antibodies but needed help developing and pro-
ducing them. Drug discovery work normally takes
years. But Lilly set a deadline for choosing a lead
antibody candidate in mid-April, just 52 days after
the blood samples were received. By July, Lilly had
started making batches in Branchburg, ultimately
scaling up to 12,000-liter bioreactors. Normally, “it
can take 12 months” to ramp up from pilot produc-
tion used for trials to full-scale manufacturing, says
Darin Moody, a Lilly senior vice president for prod-
uct manufacturing. “We basically did it in 90 days.”
Lilly aims to have five different plants produc-
ing the antibodies next year, including production
arrangements with Samsung Biologics and Amgen
Inc., as well as Fujifilm Diosynth Biotechnologies,
which will produce them for poor nations with fund-
ing from the Bill & Melinda Gates Foundation.Exactly how powerful the antibodies will prove to
be remains uncertain, despite Trump’s claims they
are a cure. “The real value is averting hospitaliza-
tions,” says Amesh Adalja, a senior scholar at the
Johns Hopkins University Center for Health Security.
He says the antibodies aren’t miracle cures and will
likely need to be administered soon after diagno-
sis to be effective. That concept was bolstered▲ Cell culture testing
vats in Branchburg, N.J.◀ A Lilly lab technician
tends to cell cultures for
coronavirus antibodies