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What It Takes to Manufacture a Vaccine

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You may not know it, but one company has the capacity to manufacture bulk drug substance for more than a billion doses of COVID-19 vaccines annually: Emergent BioSolutions, a global supplier for the Johnson & Johnson vaccine and U.S. supplier for the AstraZeneca vaccine. Emergent Executive Vice President of Manufacturing and Technical Operations Sean Kirk spoke with us recently to explain what goes into the heroic production of all these doses—in other words, what it takes to help defeat COVID-19.

How the vaccine works: The complexity begins with the vaccines themselves, which are amazing feats of bioengineering. The two vaccines have broadly similar structures, though they are made by separate, quarantined production lines in the Emergent facility. (As Kirk says, you can’t even take a wrench from one production suite to the other.)

You can think of this type of vaccine as a sort of beneficial Trojan Horse:

  • Particles of a virus called an adenovirus, which usually causes cold and flu-like symptoms, are engineered to hold the DNA of SARS-CoV-2 (the official name of the coronavirus)—and to not be infectious themselves.
  • Those adenovirus particles enter your cells and program them to produce a component of SARS-CoV-2 called a spike protein.
  • That process provokes an immune response, teaching your system how to defeat the real COVID-19.

So how do you make it? As you might guess, making such a precise vaccine is itself a complicated and delicate process.

  • You need to make a lot of modified adenovirus particles very fast, while ensuring they aren’t infectious and can deliver their payload of SARS-CoV-2 DNA.
  • To cut a long story very short, the production process involves “infecting living cells [with the modified adenovirus] and turning them into virus factories,” as science writer Derek Lowe says.

Where Emergent comes in: Emergent handles the manufacturing process, which results in something called “bulk drug substance,” Kirk explains.

  • “Our facility produces the high concentration active pharmaceutical ingredients, the viral vectors themselves,” he says. “Then we freeze them down and ship them out to what’s called a fill/finish facility, which dilutes the concentrate and fills vials or syringes with it.”

The numbers: That concentrate will eventually become part of the 100 million Johnson & Johnson doses and 300 million AstraZeneca doses purchased by the U.S. government.

What it takes: Kirk gave us a glimpse of just how much effort went into getting ready for a new vaccine.

  • 6 or 7 months: That’s all Emergent had, for a process that normally takes years. Consider how much goes into it, Kirk says: ordering equipment, getting that equipment to work correctly and comply with regulations, “working out the kinks from the complex biological manufacturing process”—and then scaling it up and optimizing it to make large quantities of vaccines as quickly and safely as possible.
  • 800 new jobs: Emergent had to increase hiring, adding approximately 800 new jobs in 2020, many of which were dedicated to COVID-19 response across three Maryland sites.
  • Group effort: Emergent works incredibly closely with Johnson & Johnson and AstraZeneca, along with the U.S. government and the company’s own suppliers. “We have leveraged U.S. government rated orders to get access to critical raw materials and equipment. We’ve depended upon certain suppliers, who were likewise rallying to the cause, to really step up and ramp up their overall capability and capacity,” says Kirk.

Why can’t you go faster? Kirk says he gets this question all the time and wants to impress upon readers that these are very complex biologic manufacturing processes.

  • “They are highly regulated, highly technical and have to be highly reproducible,” he continued. “We are growing living cells and then we are infecting them with these viral vectors.”
  • Furthermore, everything that Emergent produces must have the same characteristics of the product used in the clinical trials—“that’s the essence of biologic vaccine development,” Kirk says. “That’s the only way you can ensure safety and efficacy.”

The last word: Kirk tells us what he tells his employees: “It’s unbelievably difficult, more difficult than anything I’ve done in my entire career. But I can’t think of a more awesome opportunity to leave an indelible mark on the course of human history. We are going to help return a degree of normalcy to society. We’re going to help reunite families, open up economies and put a smile on children’s faces when they go back to school. And that’s an honorable and amazing thing.”

This article is the first in an exclusive four-part series on Emergent’s accelerated production efforts.

Business Operations

OceanGate’s CEO on Streamlining its Operations with PTC Onshape

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The NAM’s Makers Series is an exclusive interview series featuring creators, innovators and trailblazers in the industry sharing their insights and advice. Meet Stockton Rush, CEO and co-founder of OceanGate. In this edition of the NAM’s Makers Series, Stockton explains how OceanGate uses PTC’s Onshape cloud-based CAD to design its manned submersible solutions.

Business Operations

Tax Policy Makes Innovation Possible for Big Ass Fans

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For Big Ass Fans, a Kentucky-based company that manufactures fans, evaporative coolers and controls for industrial, agricultural, commercial and residential use, the eye-catching name isn’t the only thing that makes them distinctive. The company is also a leader in research and development, crediting U.S. tax policy with supporting its innovations and the jobs they create.

Investing in innovation: BAF has spent millions of dollars in R&D, even building an R&D lab on its global headquarters campus in 2008. Most recently, it pioneered new ways of disinfecting air to keep manufacturing employees healthy during the COVID-19 pandemic. And when Congress approved tax reform in 2017—including a lower corporate tax rate—the company got additional fuel for its efforts.

  • “The more incentives that are there for us to create and for our customers to purchase, the more we can deliver for everyone,” said BAF Government and Public Relations Director Alex Risen.

Risen cautions, however, that a higher corporate tax rate could impact the company’s ability to grow. Meanwhile, a prospective tax change on R&D spending could stymie innovation by requiring the amortization of expenses (as opposed to current tax policy, which allows expenses to be fully deducted in the same year).

  • “We’re always going to innovate. That’s in our DNA. But if our customers have higher corporate tax rates, that can take money out of our pockets and theirs,” said Risen. “If this new R&D tax policy detracts from a company’s ability to push and pioneer…then we’re all at risk of losing out on expedited innovation.”

Creating American jobs: BAF isn’t just using its revenues to invest in innovation; it’s also working to bring jobs and supply chains into the United States. In addition to its headquarters in Lexington, Kentucky, the company has offices in Canada, Australia and Singapore. Up until recently, it also had a manufacturing facility in Malaysia in addition to a sales office there—but BAF is in the process of moving those production jobs to the United States.

  • “It doesn’t just mean new jobs at BAF; it brings more business to American vendors and suppliers,” said Risen. “It allows them to continue trying to grow even during a downturn and uncertain times.”

Bolstering supply chains: In addition to job creation, strengthening the supply chain was another top priority for BAF.

  • “We were already working on moving those operations before the pandemic hit, but the pandemic is a reminder that you want to have that supply chain close,” said Risen. “We’ve been fortunate that we haven’t had to slow production down, because the majority of our product is here in our backyard. That speaks to where we want to be as a company that is internationally headquartered in the U.S. but serves 175 countries. We want to do our part in order to make high-end machinery a U.S. export.”

NAM support: To support companies like BAF and its customers, the NAM is leading the effort to ensure that the tax code keeps encouraging innovation. Recently, a bipartisan group of U.S. policymakers introduced legislation that would allow manufacturers to continue to deduct their R&D expenses immediately—a move that the NAM advocated for. The NAM is also working to strengthen U.S. supply chains, releasing an agenda for such actions last year.

The bottom line: “A high tide floats all boats,” said Risen. “We need to continue to innovate and deliver for companies in America—and we need to help Americans push the envelope, innovate and deliver for all of us.”

Business Operations

So You Want to Run a Vaccination Site

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Manufacturers across the country are doing their part for the pandemic response—whether that means developing vaccines, producing vials and containers or creating personal protective equipment for frontline responders. They are also increasing the capacity and efficiency of vaccination operations by embedding their manufacturing methods and technologies—as Honeywell and several partner organizations did recently in North Carolina. Now, the group has published a guide to help others do the same.

What they did: Honeywell, Atrium Health, Tepper Sports & Entertainment and Charlotte Motor Speedway formed a unique public–private initiative with a bold goal of distributing 1 million doses of the vaccine by July 4. With support from the state of North Carolina and Gov. Roy Cooper, the North Carolina Department of Health and Human Services and local governments, these organizations worked together to plan and execute efficient, safe and equitable mass vaccination events at Bank of America Stadium and Charlotte Motor Speedway in January and February.

  • “These highly efficient mass events safely vaccinated a diverse group of more than 36,000 people with scalability at a rate of nearly 1,500 vaccinations per hour with average wait times of less than 30 minutes,” according to the guide. “These successes offer several best practices for locations around the world working to get ‘shots in arms’ quickly, efficiently and safely.”

Planning and structure: The guide encourages planners to offer doses by appointment only, to schedule the first and second doses concurrently and to ensure that the venue will have enough doses to serve all its guests without any waste. Meanwhile, it advises that a “task force” staff model be put in place with cross-functional teams and a clear decision-making structure.

Site selection: Planners should consider venues like stadiums, arenas, racetracks and convention centers as mass vaccination sites. But they should also consider whether these venues have:

  • Sufficient space for social distancing;
  • Free and available parking capacity if necessary; and
  • Convenient access to public transportation.

Equity in distribution: Would-be vaccinators should take special account of underserved communities and populations, says the guide. Organizations seeking to create a mass vaccination site should engage in outreach, promote access and work to reduce vaccine hesitancy. That might require:

  • Developing early partnerships with diverse faith-based, health care, business, educational, news and entertainment organizations;
  • Working with the local government to create free transportation options; and
  • Connecting with social influencers and community members who can help reduce vaccine hesitancy in targeted areas.

Process: This how-to guide lays out the processes an organization should be aware of and plan for—from pre-event scheduling to on-site check-in, screening, vaccination and observation. The organization should also plan to do post-event data entry, which ensures both their team and local governments can document doses correctly.

Why it matters: “Like any other successful endeavor, mass and community vaccination events require deep planning, strong leadership, committed partnerships and an army of support,” the guide says. “Missing even one of these critical elements can severely limit the effectiveness of an event, ultimately slowing down a community’s recovery… We hope these learnings will be helpful to government leaders who are building a strategy to get their community vaccinated.”

The last word: As NAM Vice President of Brand Strategy Chrys Kefalas said, “Manufacturers like Honeywell and their partners in health care and government are leading us toward the end of the pandemic. It’s important that all of us play our parts to help them, as the NAM and The Manufacturing Institute’s ‘This Is Our Shot’ project emphasizes. Our industry has been protecting Americans from COVID-19 for a year now, and our job isn’t over yet.”

You can download the full guide here.

Business Operations

NAM Board Reelects Lamach and Fitterling

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The NAM Board of Directors has reelected Trane Technologies Chairman and CEO Mike Lamach as its chairman and Dow Chairman and CEO Jim Fitterling as vice chair.

Lamach and Fitterling provided stalwart leadership during an extraordinarily difficult year. Under their guidance, the NAM achieved notable successes, ensuring that policymakers accounted for the industry’s needs and helping to make the production of masks, vaccines and other vital supplies possible.

And that’s not even the half of it. Here are some of the highlights from the NAM’s past year:

  • COVID-19 response: Our “American Renewal Action Plan” shaped legislation and administrative action to get manufacturers the support they needed. The NAM team’s advocacy secured more than six dozen policy accomplishments.
  • PPE production: Our Creators Respond initiative helped send millions of pieces of personal protective equipment and other medical supplies to hospitals and health facilities—and after the election, the NAM worked with the Biden transition team to share insights on PPE production and distribution.
  • Workforce development: The Manufacturing Institute’s initiatives, including Heroes MAKE America, the STEP Women’s Initiative and the FAME apprenticeship program, strengthened manufacturing’s workforce pipeline and helped close the skills gap.
  • Legal victories: The NAM led the business community in court on issues like protecting vital immigration and standing up against regulatory overreach.
  • Fight for opportunity: Through our Pledge for Action, the NAM has committed our sector to taking 50,000 tangible actions to increase equity and parity for underrepresented communities and creating 300,000 pathways to job opportunities for Black people and all people of color.

A look ahead: With Lamach and Fitterling at the helm and an exceptional team in place, the NAM is poised to expand on its successes over the past year and continue to strengthen manufacturing across the country. Already, the NAM is working closely with the new administration and Congress to make sure manufacturers’ voices are heard. To learn more about the breadth of the NAM’s policy agenda, read its newly updated blueprint “Competing to Win.”

Small and medium-sized manufacturers: Meanwhile, the current chair of the NAM’s small and medium-sized manufacturers’ group, BTE Technologies President Chuck Wetherington, will also serve another two years in his position. Ketchie President and Owner Courtney Ketchie Silver will replace retiring Protolabs President and CEO Vicki Holt as vice chair.

The last word: “Today more than ever, manufacturers are the arsenal of democracy. In our nation’s time of need, manufacturers have stepped up and manned the front lines to provide essential goods for the American people. With Mike and Jim’s sound guidance and experience, the NAM will continue to be a leading voice for the business community during these unprecedented times,” said NAM President and CEO Jay Timmons.

“Our board leaders will also help our industry lead America’s recovery and renewal—helping to strengthen and unify our nation during extraordinary times. And above all, we will advance the values that make America exceptional: free enterprise, competitiveness, individual liberty and equal opportunity.”

Business Operations

What Manufacturers Should Know About Vaccines

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As we wait to get our shots, many people still have questions. Does it matter which vaccine I get? What safety precautions should I continue to take? We talked to highly cited infectious disease expert Dr. Aaron Richterman of Penn Medicine to get some answers to these very real concerns.

Which vaccine? As Richterman tells us, the priority for vaccines is preventing bad outcomes—death and severe illness. And the good news? “The really, really good news is that all of these vaccines that have been tested so far—all of them—prevent severe outcomes.” That list includes vaccines made by Pfizer, Moderna, Johnson & Johnson, AstraZeneca and Novavax. (Only Pfizer and Moderna are approved in the U.S. so far, while the J&J vaccine is expected to be approved soon.)

  • And the clincher? “When you put all the trials together [including the Russian vaccine trial], there are somewhere around 80,000 to 90,000 people total who have received the vaccine, and none of them have required hospitalization—and none have died,” says Richterman.

Let’s talk specifics: What about the different numbers we’ve been seeing? As Richterman points out, we’re all used to seeing different headline numbers—95% effective, or 72%, and so forth. But what does that really mean?

  • What those numbers represent is the “reduction in any symptomatic illness at all,” he explains. But the main thing we should be concerned about is the prevention of severe illness or death—which all the vaccines do extremely well.

When should I get it? As soon as possible, says Richterman. “At this point in time, and probably for the next four to six months in this country, the benefit of getting the first vaccine available to you is going to outweigh any potential benefit from waiting for the next one.” If you are offered an FDA-approved vaccine now, he says: “take it.”

What you should know: Here are some key facts to keep in mind as you read media coverage of vaccinations, says Richterman.

  • Quality: “The quality of evidence underpinning the data for these vaccines […] is grade A plus, top of the line.”
  • Safety: “These are extremely safe vaccines, among the safest out there. Some people will have temporary side effects, but they are very safe.”
  • Prevention of severe outcomes: These vaccines prevent severe outcomes to a “tremendous” degree, Richterman stresses. “If these vaccines can take COVID-19 down to something asymptomatic, or something more like a cold, that’s a big win.”

And lastly, do you have to wear masks and socially distance after being vaccinated? “Especially right now, when there’s a lot of community transmission,” Richterman says, “and we’re still learning about new variants, it’s a good idea to keep things as safe as possible.” However, “people should be informed that the vaccine reduces their risk and the risk for those around them.”

Further reading/viewing: Check out the NAM’s project to increase vaccine acceptance, This Is Our Shot, as well as its continued efforts to promote the use of face coverings.

Business Operations

Caterpillar Powers COVID-19 Relief Efforts

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Manufacturers have pitched in remarkably to help us all through COVID-19—by making things you might expect to be essential (masks, gowns) and things you might not (wire racks, foam). One major manufacturer, Caterpillar, has contributed to the relief efforts in a wide variety of ways across the country and around the world. Here are some of its contributions.

Heating hospital tents: Caterpillar generators made a key appearance in Atlanta during the worst of the 2020 spring surge. Local hospitals set up testing sites outdoors so they could admit only confirmed COVID-19 cases, thus keeping noninfected patients safer from exposure. But to do that, they needed power.

Cat® Dealer Yancey Power Systems provided exactly the power they needed, after thoroughly evaluating the sites, making a detailed plan for servicing them safely and creating an easy set-up process.

Helping to make face shields: A Peoria manufacturer of face shields was missing a critical component—and local hospitals desperately needed those shields. The manufacturer called a Caterpillar distribution center at about 9:00 one morning and had what it needed just an hour later.

Donating materials: And speaking of face shields, a Caterpillar facility in Brazil donated production materials for face shields to local manufacturers, so that doctors in their hard-hit region would be better protected.

Feeding people: The Caterpillar team in Seguin, Texas, hosted two huge food distribution events in 2020. The event in May provided more than 700 families with enough food for two weeks, while in December, the Caterpillar Seguin team and the local food bank provided food to 955 families from 10 different counties.

Powering tugboats: Remember the rousing scene in March when the USNS Comfort, a Navy hospital ship, sailed into New York Harbor? You may not recall the two tugboats that helped it dock, but they were essential. And inside those tugboats were two Caterpillar engines, which ensured the boats could serve their city when it needed them.

Providing support: The Caterpillar Foundation also committed $10 million to support global and local COVID-19 response activities. Together with the incredible outpouring of support from employees and retirees through the Foundation’s special 2:1 match, these contributions have helped keep communities safe and strong.

The last word: “Our employees, dealers and customers around the globe are doing what they can to help fight the spread of COVID-19 and ensure essential work continues,” says Kathryn Karol, Caterpillar vice president of global government and corporate affairs. “They truly embody our values in action, finding ways to help each other and their communities during these difficult days.”

Business Operations

Hirebotics’ Co-Founders on Powering a Remote Team with PTC Onshape

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The NAM’s Makers Series is an exclusive interview series featuring creators, innovators and trailblazers in the industry sharing their insights and advice. Meet Rob Goldiez and Matthew Bush, co-founders of Hirebotics. In this edition of the NAM’s Makers Series, Goldiez and Bush explain how Hirebotics uses PTC’s Onshape cloud-based CAD system to power its design teams.

Business Operations

How an Analytics Company Keeps Hospitals Running

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Behind every hospital bed, doctor, ventilator, mask and the millions of other components that make up a hospital is the same thing: a prediction. How much will we need, and where, and when? Analytics make those predictions as precise as possible—and that’s never been more essential than during COVID-19.

Analytics software company SAS understood the problem better than almost anyone. And not long after the pandemic started, it partnered with the Cleveland Clinic to create an innovative dashboard that would help hospitals optimize their resources and keep saving lives.

How it started: On March 17, the Cleveland Clinic asked SAS to create models that could predict the spread of COVID-19. They wanted to understand the strain that COVID-19 might put on the hospital, and by extension, its resources—from ventilators to PPE to dialysis machines to their doctors’ time.

Why it’s different: While plenty of organizations around the world were building epidemiology curves to track the course of the virus, SAS and the Cleveland Clinic built a framework that offers more. The collaborative team came up with a range of scenarios based on varying inputs like virus transmissibility and social distancing. With SAS vetting the math behind the models, the Cleveland Clinic identified which curve it was on at a given time and developed action plans in advance.

How it worked: The models helped the Cleveland Clinic identify markers for potential surge scenarios and recognize when the actual severity of the outbreak would fall short of some projections. That means it did not have to cancel planned events like routine surgeries and treatments and was able to continue treating non-COVID-19 patients.

  • “One of the challenges of this pandemic is the public health cost of dislodging patients with cancer or chronic disease to make room for COVID-19 patients,” said Dr. Steve Bennett, director of the global government practice at SAS. “These models can tell you that you may not need the surge capacity; you can keep doing the sorts of standard work that you’re doing. That has a valuable public health benefit.”

Sharing the wealth: SAS didn’t want to keep such a potentially valuable tool to themselves—so the team made their code publicly available on software development site GitHub. Other hospitals and public health agencies have adapted it, given feedback and made it their own, thus contributing to innovation and effective response.

  • “Cleveland Clinic is very advanced in analytics—but at the same time, they really wanted to help smaller organizations and smaller clinic hospitals that may not have big data science teams,” said Natalia Summerville, senior manager at SAS. “That’s why they allowed us to make everything publicly available, which was amazing.”

What’s next: The technology has applications even beyond the current crisis. “SAS aspires to be the platform of the future,” said Dan Abramson, executive director of U.S. manufacturing at SAS (and an NAM board member). “It’s got capabilities in modeling and AI and data management and visualization. So, the knowledge we gain from projects like these can be a launching point for pretty much any business problem or challenge.”

The last word: “The collaboration worked,” said Andrew Williams, principal analytical solutions architect at SAS. “The analyst community has always spoken very highly of our technology and analytic capabilities in AI, machine learning and optimization—and I think what we’ve shown here is that we can apply them to critical use cases across the board and across industries.”

Business Operations

The Story Behind “This Is Our Shot”

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The NAM and The Manufacturing Institute have launched a large-scale project to promote vaccination among manufacturing workers and communities, called “This Is Our Shot.”

As NAM President and CEO Jay Timmons describes it, “This project builds on our months of work advocating the use of face masks and other smart health measures to protect all Americans . . . . Now is our opportunity as a country to end this pandemic. Our future depends on all of us rolling up our sleeves and getting armed against COVID-19.”

So how did they make it happen? We recently talked to NAM Vice President of Brand Strategy Chrys Kefalas about the inside story.

Why: As Kefalas puts it, “We have a crisis. Depending on which study you look at, between 30% to 40% of Americans say they will not get a COVID-19 vaccine. We have to take direct aim now at vaccine hesitancy; otherwise, we’ll have safe and effective vaccines and not enough people willing to get them to reach heard immunity.”

Why the NAM and the MI? The NAM, along with its workforce development and education partner, the MI, has a “singular power” to leverage manufacturing’s unifying position as a trusted community resource, Kefalas explains.

How: In the spirit of manufacturers everywhere, let’s take a look at how this project got made.

  • First, the research: “We’ve relied on a wide range of suggestions and guidance, from manufacturers of all sizes and all sectors. We’ve also sought recommendations from the Gates Foundation, the CDC and other public health leaders,” says Kefalas.
  • Second, the reach: “We’re engaging company medical officers, local health care providers and community members who can change hearts and minds about COVID-19 vaccination.”
  • Third, the sights: “It’s going to take videos, photos, flyers, posters, emails—and other very visible signs that others are getting armed against COVID-19.”
  • Fourth, the psychology: Research shows that a sense of group loyalty or patriotism can boost vaccination numbers, Kefalas explains. To create that sense of solidarity (and social influence), the NAM and MI will distribute red and yellow ribbon pins for those who get vaccinated—and encourage people to put up red and yellow ribbons outside their homes once their whole households have received the vaccine.

What can you do? The initiative is providing manufacturers with communications materials to share with their teams. As Kefalas says, clear, consistent and direct communication from employers and peers really helps. “And when you are conveying medical information, rely on the experts like medical officers and direct people to their medical providers,” Kefalas suggests.

All we need is love: In case you missed it, the first video in this initiative dropped yesterday, a charming short called “I Love Frank.” Kefalas explains the idea: “Caring for others is really the one message that seemed to resonate across all demographic groups. Vaccinations should be really simple, because it comes down to one thing: we want to protect the people we love.” You can’t say it any better than that.

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