By Matthew Dalton and Joseph Walker | Photographs by Agnes Dherbeys for The Wall Street Journal
High-profile drug companies have turned to a quickly assembled
network of smaller, lesser-known manufacturers to mount an
unprecedented effort to produce Covid-19 vaccines.
The companies have been forced to rely on outside manufacturers
world-wide because their new vaccine technology has never been used
at industrial scale. Even drugmakers using more conventional
technology are getting outside help because of the speed at which
they need to ramp up production to meet orders for more than a
billion vaccine doses next year.
"We're working harder and faster than we ever have," said Ger
Brophy, executive vice president of biopharma production at Avantor
Inc., one of dozens of third-party manufacturers that have been
mobilized to make vaccine ingredients, combine them into finished
products and fill them into vials. Dr. Brophy says the company's
plants have added workers and night shifts to keep up with
demand.
Moderna Inc.'s vaccine, which received emergency authorization
from the U.S. Food and Drug Administration on Friday, and another
from Pfizer Inc. and BioNTech SE rely on a new messenger RNA
technology, named after the molecular couriers that deliver genetic
instructions to a patient's immune system to fight Covid-19. That
makes industrialization easier than for traditional vaccines,
pharmaceutical experts say, because manufacturers don't have to
work with live pathogens.
But to produce hundreds of millions of doses, manufacturers
stitched together supply chains in a matter of months -- a process
that usually takes years -- before clinical trials were even
completed.
Some in the industry liken that endeavor to building an airplane
while flying it. "Many of these airplanes have never been made
before," said Dr. Brophy.
Avantor, based in Radnor, Pa., makes lipids that are formed into
nanoparticles to carry fragile mRNA into human cells. Lipids have
traditionally been sourced from animals, but the process isn't
efficient for making hundreds of millions of doses, so the company
has had to quickly increase its capacity for producing the
substances synthetically from plants, says Dr. Brophy.
The rush to ramp up production meant that Recipharm AB, a
Swedish company hired to help produce Moderna's vaccine, began
instituting Moderna's directives for vaccine production without a
final contract between the companies, jumping ahead of the usual
legal formalities.
Mikael Ericson, general manager of a Recipharm plant in Monts, a
town in central France, said it usually takes 12 to 36 months to
begin production. "Now this will be done in two to three months,
which is extremely challenging for everyone," he said.
Recipharm's plant in Monts plans to start shipping finished
doses of Moderna's vaccine early next year. The plant is processing
Moderna's active ingredient, which is being made by a different
contract manufacturer, Lonza Group AG, at a factory 480 miles to
the east in the Swiss Alps.
The Recipharm plant's specialty is sterile injectable drugs, but
it has never produced a vaccine before. Recipharm plans to operate
its production lines 24 hours a day, seven days a week, said Mr.
Ericson.
"Let's say you have some kind of hiccup with the supply chain,
you will not be able to recover" lost production, said Mr.
Ericson.
Recipharm is hiring around 65 workers and training them to work
in the ultraclean conditions of its production lines. It is
purchasing banks of freezers to store, under high security, the
active ingredient and finished doses ready to be shipped. New
mixing tanks will dilute the active ingredient with purified water
and some other substances. Then the mixture will be filled into
vials.
Pharmaceutical companies rarely outsource vaccine production,
and in compressing the process there is little room for error. The
U.S. government helps to fund and coordinate the manufacturing
effort of many companies through Operation Warp Speed, an
initiative led by the Defense Department and Department of Health
and Human Services.
U.S. Army officers who specialize in logistics are embedded
across nine manufacturers to ensure production runs smoothly and
safely, helping to address problems as they arise, such as machines
breaking down or obtaining equipment or raw materials, says Marion
Whicker, deputy chief of supply, production and distribution at
Operation Warp Speed.
Additionally, companies in the vaccine supply chain are subject
to exacting regulations to prevent contamination. Over the past 16
months, a Bloomington, Ind., plant owned by Catalent Inc. that has
been enlisted by Moderna to help make its vaccine was cited for
multiple regulatory violations by the FDA, according to inspection
reports reviewed by The Wall Street Journal. Inspectors in
September observed workers not properly disinfecting their gloves
and allowing sterile forceps to touch potentially contaminated
surfaces, the report said. In October 2019, FDA inspectors found
several violations in a different part of the plant related to the
production of an injectable drug, including failing to follow
proper sterile cleaning techniques.
Catalent says it fixed the problems identified by inspectors in
2019 and has presented an action plan to the FDA to correct
shortcomings found in this year's inspection.
"Catalent takes all these observations seriously, and all are
promptly addressed through corrective and preventative actions,"
the company said.
Lonza first made contact with Moderna in March, telling the
Cambridge, Mass.-based drug company that there was a free building
at its factory in the Alpine town of Visp that could be used for
vaccine production. Ten months later, the building houses three
production lines, each capable of making enough Moderna vaccine for
100 million doses annually.
"You have to imagine, part of the building is empty," said
Albert Baehny, chairman of Lonza Group. "In less than 11 months,
you install a very complex, delicate manufacturing process with a
completely new technology for a very delicate product."
Lonza has set up another production line at its facility in
Portsmouth, N.H., with capacity to make 100 million doses for the
U.S. market. The vaccine will be sent to Catalent's Bloomington
plant for filling and packaging.
"We've been pleased with the production scale-up thus far and
optimistic about our production estimates for 2020 and 2021," said
Moderna spokesman Ray Jordan. The company has said it would supply
20 million doses for the U.S. in 2020, and 85 million to 100
million doses for the U.S. plus 15 million to 25 million doses for
outside the U.S. in the first quarter of 2021. Moderna's vaccine,
like Pfizer's, requires patients to receive two shots.
Pfizer is coordinating with BioNTech's contract manufacturers in
Europe and completing the manufacturing process at its own
facility, a spokesman said.
Pfizer is finishing and packaging its vaccine at a facility in
Puurs, Belgium, to supply Europe, the only current source of
production in the region. But Pfizer's partner, BioNTech, has hired
several contract manufacturers to quickly scale up production. One
is Delpharm, a French contractor that is preparing to process and
fill tens of millions of doses of the vaccine starting in
April.
BioNTech was looking for a producer that could handle large
volumes quickly, said Stéphane Lepeu, Delpharm's chief commercial
officer.
"The price was, for once, less important," Mr. Lepeu said. "The
whole world is waiting for this vaccine. The priority of priorities
was to have as much quantity as possible, as soon as possible."
Write to Matthew Dalton at Matthew.Dalton@wsj.com and Joseph
Walker at joseph.walker@wsj.com
(END) Dow Jones Newswires
December 19, 2020 05:44 ET (10:44 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Catalent (NYSE:CTLT)
過去 株価チャート
から 6 2024 まで 7 2024
Catalent (NYSE:CTLT)
過去 株価チャート
から 7 2023 まで 7 2024