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8 Pharmaceutical Technology ® The Real Message Behind Commercial mRNA Products April eBook 2023 PharmTech.com mRNA TReNds Manufacturing considerations For context on the manufacturing side, the pandemic cast new light on the importance and vulnerabilities of the distributed nature of the pharmaceutical industry's specialized supply and shipping infrastructure. Phar- maceutical scale permits, like those for semiconduc- tor or surgical hospital consortiums, lower barriers to entry for otherwise fantastically complicated or fit-for- one-purpose-only technologies to gain traction. Scale also enables designs dedicated to eking out the last precious microns of performance or purity, which can determine the usefulness or failure of an approach. But specialization at this scale also proliferates nesting doll dependency. Each successive layered network of inter- locking manufacture depends on an exact product or design specification to feed it. Shortfalls in one seem- ingly survivable area cascade like crashing waves onto the following layer, and so on throughout the system. Subcontractors focused narrowly to a single design task are reliant on yet more specialized subcontractors. By intention, all are equally synchronized in configuration, tolerance, and material conformation. Seeking alterna- tives is not simple, easy, or at times even possible. It was a growing source of pride to become so finely tuned that pharmaceutical manufacturing migrated to a just-in- time (JIT) mode to maximize these benefits, but this also exacerbated interdependencies. And then COVID-19 hit. Looking back at a 2022 conversation, Kevin Nepveux, vice president, Pfizer Global Supply, recalled, "Devel- opment and launch of the Pfizer-BioNTech COVID-19 vaccine was unlike anything I have experienced in my career in pharma manufacturing—and without a doubt the highlight. Multiple mRNA vaccine constructs were manufactured and tested in the clinic in parallel versus the normal sequential approach, and the selected strain was immediately scaled, both up and out, to begin man- ufacturing launch supplies before the pivotal efficacy study even started. In manufacturing alone, Pfizer and BioNTech committed over $1B in CapEx and OpEx be- fore the first sign of efficacy." Pfizer went all in, com- ing out the other side having a changed perspective, as Kevin observes. "Learnings from the vaccine will be enduring, including streamlined internal governance, bringing on multiple supply chains simultaneously compared to normal post-approval expansion, and simplified regulatory engagement" (4). Pfizer reacts to pandemic Pharmaceutical Technology® inter viewed Jane True, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead, Pfizer, for her thoughts on this topic. What follows is an examination of what occurred during the pandemic, and what new ways of thinking toward preparedness now prevail. PharmTech: The traditional JIT model became a handicap when suddenly everybody had to scramble. So, do you have a viewpoint on the JIT model and what you guys did to work around it? True (Pfizer): I have a little bit of a different perspec- tive on that. The JIT models before, if we talked about pandemic preparedness, was a lengthy process. So, JIT was actually not JIT. What I think mRNA technology brings into the fold is something a lot closer to real JIT, where you can react to things that are changing on an ongoing basis and have something that's a lot better, let's say matches a lot closer to what's actually circulating, versus what I think what you're calling JIT. PharmTech: Pfizer did a lot of things in parallel to get ahead of this. Would you like to point to a couple of those things? Interview with Jane True of Pfizer Chris Spivey, editorial director of Pharmaceutical Technology®, spoke with Jane True, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead, Pfizer, about her thoughts on the COVID-19 pandemic. What follows is an examination of what occurred during the pandemic and what new ways of thinking toward preparedness now prevail. We also consider mRNA as a successful battle tested platform, and what new uses we might turn it toward. To watch the entire interview, visit PharmTech.com "What I think mRNA technology brings into the fold is something a lot closer to real JIT ... —Jane True, Pfizer