This story first appeared in the Quarter 1/2022 edition of CSCMP’s Supply Chain Quarterly, a journal of thought leadership for the supply chain management profession and a sister publication to AGiLE Business Media’s DC Velocity.
Imagine that your company is gearing up to launch a new product. First, take a moment to consider all the supply chain complexities inherent in any new-product introduction. Now imagine that you’ll be dealing with a product that’s based on brand-new technology, will require manufacturing processes unlike any your company has ever used, and will require a specialized temperature-controlled transportation and distribution network.
But wait, there’s more: Now imagine that the customer base for this product runs into the billions and is spread all over the world. And that these billions of customers are eagerly awaiting your new product—and closely scrutinizing your delivery performance.
And now, imagine that you have to design the supply chain for this product in less than a year.
That was the challenge Jim Cafone and his team at the pharmaceutical giant Pfizer faced when they were tasked with creating the supply chain for the Covid-19 vaccine, in conjunction with Pfizer’s partner BioNTech.
Cafone, who is vice president of network design and performance for Pfizer Global Supply, says there was never any doubt that the company would accept this challenge. For Pfizer, one of the world’s largest vaccine manufacturers, unlocking a vaccine for Covid-19 and getting it to as many people as possible, as quickly as possible, felt like a moral imperative.
It quickly became apparent that one of the most promising ways to defeat the virus lay with the new messenger RNA (mRNA) technology that was being developed by BioNTech, a biotechnology company. That led Pfizer to form a partnership with BioNTech to produce the vaccine. But there was a hitch: At the time, Pfizer had an extensive manufacturing and distribution network for vaccines and pharmaceuticals, but none of it was designed for mRNA-based products. A whole new process and network would have to be created essentially from scratch—and with the virus sweeping across the globe, there was no time to lose.
In this interview with DC Velocity Editor at Large Susan Lacefield, Cafone talks about how his team rallied to meet that unprecedented challenge, which required them to change the very way that they worked.
Q: Did Pfizer have any previous experiences you could draw upon when developing the supply chain for the Covid-19 vaccine?
A: As one of the largest vaccine manufacturers, we of course had experience with building out supply chains, but not at the same scale. Nobody builds a manufacturing network for a pandemic. In a world with a population of 7.6 billion to 7.8 billion people, you are talking about a need that has never [arisen] before.
Up until Covid, the No. 1 vaccine in the world was a product called Prevnar [which is used to prevent diseases caused by the pneumococcal bacteria], and in 2019, we manufactured roughly 200 million doses of that.
But Prevnar uses a different sort of technology than the Covid vaccine. We were discussing whether to use what I would classify as “tried and true” traditional vaccine technology or move to the mRNA platform. We chose the mRNA platform due to the confidence we had in our partner.
Q: What sorts of challenges did the move to mRNA technology create?
A: In my view, there were three major challenges. One was building out an mRNA manufacturing supply chain that had not previously existed anywhere in the world. There just wasn’t enough equipment in the world [to meet our needs] if we used standard approaches. The type of scale that we needed just didn’t exist. So we had to fundamentally reinvent the manufacturing process, which included not only making the mRNA but also filling and finishing vials.
Challenge number two was building out a network of innovative collaborators. We have roughly 280 components coming in from 85 suppliers in 19 different countries, and we had to build out a network using these collaborators.
The third thing was the whole logistics side, which [included] building a shipment device that could handle deep-frozen vaccines. mRNA doesn’t like heat at all. So we optimized [our supply chain] on speed, and we optimized on deep-frozen.
So those were the three big challenges: reinventing the manufacturing process, developing a brand-new manufacturing network with a lot of innovative players, and reinventing deep-frozen distribution on a global scale.
Q: That global piece has got to be really difficult, because it’s one thing to keep product frozen in, say, the United States or Europe, but another thing altogether when you’re distributing in remote parts of Africa or Asia.
A: Exactly. The shipping container we designed was meant to double as a portable storage device. It wasn’t a situation where you had to immediately open it up upon receipt. We designed it so that it kept temperatures consistent up to, I want to say, about 10 days.
We wanted it to be easy and efficient to pack. We needed a product to be stable for up to 10 days in remote locations, and we wanted it to be [able to be] returned or reused. So that was like another medical innovation.
All during that time, we took 50% out of our cycle time for manufacture. We expanded wherever we could in our network to get more volume. We put $2 billion worth of capital at risk in order to optimize its speed. In 2021, we manufactured 3 billion doses, and 1 billion of those went to low- and middle-income countries. Our focus was on health-care equity regardless of where you were in the world.
Q: Another thing Pfizer did was to redesign the manufacturing process to be very “micro.” How did you accomplish that?
A: [Even before Covid,] the entire manufacturing process had been getting what I would call “miniaturized.” That miniaturization is based on the fact that, as the industry starts to attack more rare diseases, you don’t need big manufacturing infrastructures anymore. You need small, nimble manufacturing infrastructures.
What was interesting with the Covid vaccine is that we needed massive scale, but we couldn’t find 6-, 12-, or 20-thousand-liter vessels at that time to produce this mass volume. They just didn’t exist anywhere in the world. Again, you’re talking about a patient population of potentially 8 billion people. So we decided to take a page out of both books and look at how do we miniaturize, and, instead of scaling up, how do we scale out.
The answer is basically a miniaturized manufacturing plant. What we did was to design those [miniaturized plants] so that you could start to create racks of them. Almost like you see in a data center: If you go into a data center, you might see a rack of 10 servers, but if you go into an Amazon data center, you might see thousands of feet of servers, right? As you add [servers], you are adding computer power. As we were scaling out [our miniaturized plants], we were adding in volume. We redesigned the entire process to be like a “factory in a box,” and then you could start to replicate those in a way that is fundamentally equivalent to server arrays in a data center. That is how we largely did it.
Q: In the midst of all that, how did you build a network of suppliers to collaborate with you on a very new technology?
A: The genetic sequence for the SARS virus was updated on Jan. 12, 2020. That was when BioNTech approached us with their mRNA Covid technology. The way that I describe it is, it was a great marriage. They had great science. We had the best development organization and, I would argue, the best supply chain organization. Now, I’m biased, of course.
Once we decided to go with mRNA technology, we approached our suppliers that were in the mRNA space as rapidly as possible. The challenge we had was that mRNA was largely an academic exercise—a medical school exercise—at that time. Suppliers were really great at supplying those [researchers], but they were supplying relatively small amounts. Then we were calling up and saying, “Hey, we need plasmids, or capping agents, or some of the other materials. Can you send us some of this material?” They would then ask us how many liters we would need, and we were saying, “No. No. No. We need tens of thousands of liters.”
We worked exceptionally closely with all of our suppliers in an open, innovative fashion in order to get the volume. In some cases, when we couldn’t get the volume by helping them troubleshoot, we brought the volume into our [own manufacturing] network.
Q: Do you think the pandemic-induced crisis made that collaboration with external partners a little easier?
A: I definitely think there was a different sense of purpose. Now, of course, every pharmaceutical is important to some patient out there, but this one had an even larger sense of purpose. I also think our suppliers saw that sense of purpose in our light-speed culture, which grew pretty rapidly. It was all about speed. It was all about innovation. It was all about breaking down bureaucracies. It wasn’t about governance and meetings and PowerPoints anymore. It was all about the breakthrough mindset.
It was an interesting cultural element because my team designed the network during meetings that I wasn’t in. I was perfectly happy not being in them, because people were accountable for getting the work done. I never was on a call where there were more than maybe a dozen people at the meeting. If you were at the session, you were there for a purpose. You weren’t just there to listen.
You know, we have all been on conference calls in our careers where, unfortunately, you jump on and there are 50 people on there, and 30 are trying to get a word in. Again, it was all about speed, agility, innovation, and a breakthrough mindset, which means by default, you have to feel comfortable not being a part of everything. Let the organization as a whole do its work.
Q: And now Pfizer is starting to ramp up distribution for the Paxlovid antiviral pill. How is that different from your vaccine-distribution efforts?
A: Fundamentally, we are doing it all over again. The challenge you have is the volume, because now you are not dealing in biological processes; you are dealing in physical chemistry processes. What we are working through now is basically how quickly we can ramp up once again.
To put it in perspective, the highest volume of pharmaceuticals we ever produced was for Lipitor, the cholesterol-lowering agent, in 2010. It was one of its final years of patent protection, and we manufactured 250 metric tons of active pharmaceutical agents. That is the largest drug we have ever produced by volume. For Paxlovid, this year we need to produce 500 metric tons, so two [times as much as we did with] Lipitor. By the way, that Lipitor [production volume] that I talked about was during year eight or nine of its life cycle.
Q: Right, so you had already figured it all out.
A: We’d figured it all out, and we had seven generations of process improvement [under our belts]. With [Paxlovid], we’ve got to produce 500 metric tons, and we need to do that within the first year of launch. We are assembling a network of active pharmaceutical ingredient suppliers from all over the globe, including our own assets from product tableting operations and packaging operations. Again, [we’re doing] everything we can do for speed and agility.
Q: One last question: How do you keep your team from burning out?
A: We are fortunate. Pfizer has helped everyone, with all sorts of tools, to take a break. We have been focusing on doing everything we can to get people to [attain] a proper work/life balance in this difficult time. We have been focusing on mindfulness. We have been focusing on taking the right breaks at the right time.
The problem we have, fundamentally, is that people want to solve these problems. We didn’t have any issues with getting people into our manufacturing plants. We have people who wanted to come in because, even if they aren’t making the [Covid] vaccine or Paxlovid, they’re still making a lot of medicines that people need. We actually have trouble getting people to stop working and to feel OK with taking a break. It’s clear that our people have a commitment to Pfizer’s purpose: “Breakthroughs that change patients’ lives.”
Editor’s Note: For more on how Pfizer tackled the cold-chain challenges it encountered in distributing its mRNA vaccine, see “The vaccine that came in from the cold,” by Yossi Sheffi, in the Q1 2022 issue of DC Velocity’s sister publication, CSCMP’s Supply Chain Quarterly.