Some eight months into the COVID-19 pandemic, much of the global focus still revolves around vaccine development. But now, as several candidates approach the finish line, the vaccine supply chain and manufacturing is set to become a focal point in the global distribution effort.
While some drugmakers have been set back by the challenge of manufacturing enough doses to keep up with demand, New Jersey's Johnson & Johnson thought ahead. Leaning on its years of experience, the drugmaker is well on its way to producing 1 billion doses of its COVID-19 vaccine in 2021 and is looking ahead to 2022, said Paul Lefebvre, vice president of strategic initiatives and COVID-19 vaccine supply chain at J&J's Janssen unit, in an interview.
While no one could have predicted the scope of the COVID-19 pandemic, J&J had systems in place to grapple with the unprecedented event—the same crisis strategies, in fact, it leveraged in response to Hurricane Maria in 2017, Lefebvre said.
The company also has plenty of experience in launching new drugs, a resume that would help in the event of a global rollout for the vaccine. Meanwhile, J&J's business continuity plans are helping to stabilize J&J's overall supply chains, "which is really managing [the] crisis," Lefebvre added.
Now, as the end of the year looms and J&J's shot pushes through the final leg of its clinical run, the drugmaker has racked up a global cadre of manufacturers and packagers, teeing up the company to make good on its goal to deliver 1 billion shot doses per year in 2021, Lefebvre said.
Back in April, J&J signed on New Jersey-based CDMO Catalent to lock down manufacturing capacity at its Bloomington, Indiana plant, where the manufacturer has set the goal to hit a 24/7 manufacturing schedule by January. And in July, Maryland's Emergent Biosolutions joined the fold, inking a five-year pact to churn out drug substance.
Those manufacturing pacts, alongside a deal with Michigan's Grand River Aseptic Manufacturing (GRAM), should help J&J meet its 100 million dose supply order with the U.S., penned in August for $1 billion, or $10 per dose. At this stage, contracts with Emergent, Catalent and PCI Pharma Services—on the hook for packaging work—are "full bore up and going" and "operational in terms of activities to achieve the tech transfers and start manufacturing according to our timeline," Lefebvre said.
Elsewhere, J&J is relying on its own sites in Europe to make drug substance, while Catalent tackles fill-finish duties at its Anagni, Italy, plant. J&J just this week finalized a deal to provide up to 200 million doses to Europe, with the option to sell another 200 million shots at a later date should the vaccine pass muster in clinical trials. Separately, J&J is shipping 30 million doses to the U.K.
The drugmaker also recently teamed up with Aspen Pharmacare to manufacture J&J's vaccine at its facility in Port Elizabeth, South Africa, and Biological E in August agreed to manufacture the shot in India. A week after that deal was announced, Biological E snapped up a 39,000-square-foot facility from Akorn India—potentially adding more than 165 million doses to the drugmaker's annual capacity.
With those partnerships in place, J&J feels confident it can meet its lofty supply goals.
"The sheer speed of execution is challenging, and also the sheer volume that we need to produce. I think every manufacturer is facing the same challenges," Lefebvre said. "We have aggressive timelines—we'd say, challenging timelines—but at the same time, they're realistic. We try to make sure that we can meet our commitments."
Meanwhile, J&J's shot could have a storage and distribution edge over the likes of those from Pfizer and BioNTech, Lefebvre thinks.
"In our plans, we will bring our product at -20° C into the J&J warehouses around the world," he said.
J&J's shot is expected to remain stable for up to two years at that temperature, about -4° Fahrenheit. Once it goes out to distributors and customers, it can be kept stable at 2 to 8° Celcius (a range of about 35.6° to 46.4° Fahrenheit) for up to three months, not much colder than your average refrigerator, Lefebvre said.
The company has strong cold-chain experience, Lefebvre added, based on its long history with vaccines and biologics. Because its shot doesn't require the stringent, ultra-cold temperatures of other candidates—like Pfizer's mRNA-based vaccine, which requires storage at -94 degrees Fahrenheit—J&J argues it can provide its product safely and effectively and make it accessible in regions that may not be equipped to handle the cold-chain requirements of other shot hopefuls, he added.
To that end, J&J has pledged 500 million doses to low-income markets starting in mid-2021, Lefebvre said. The drugmaker is also engaged with COVAX, the World Health Organization's equitable vaccine distribution scheme, plus Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations, Lefebvre said.
Meanwhile, once a regulatory approval comes through, all focus will switch to supply chain, Lefebvre figures. The company, along with others vying for the same single-use materials like glass vials, will need to ensure it has enough material supply on hand—something J&J also sought to lock down from the start by signing contracts with suppliers to safeguard capacity, Lefebvre said.
"It will be challenging for sure once we start production," he said. "It will be hard to make sure you're meeting your plans on a day-to-day basis. And in the event that you don't meet those plans, you need to be able to change your plans to manage how you'll still execute your deliveries to governments."
Lefebvre credits the drugmaker's strong positioning to its many collaborations, not just with manufacturers, but governments and health agencies, too. As for how those partnerships could extend beyond the pandemic, the industry will need to do some serious soul searching about how to implement changes in the long term to speed up the path of life-saving medicines to market, he figures.
Other countries are looking at systems like the U.S. Biomedical Advanced Research and Development Authority, too, as they aim to prepare for future public health crises, Lefebvre said. For J&J's part, the drugmaker has certainly picked up a few lessons for whatever the world chooses to throw at the industry next, Lefebvre added.