Changing the way therapies work, and the changing work of making therapies.
Submitted by CRB
By Noel Maestre, PE, LEED AP, Vice President, Life Sciences
This article originally appeared in our 2021 Horizons Life Sciences report, which includes insights from industry leaders and CRB’s experts. Get your copy of the report here.
For the five and a half billion people around the world who have so far received a COVID-19 vaccine, the FDA’s 2021 approval of Pfizer-BioNTech’s offering may not seem like a big deal. It was available under emergency use authorization before, and now it’s here to stay—so what?
For those of us inside the life sciences industry, though, the “so what” is significant. While dangerous variants continue to surge, and drug manufacturers extend their fight against the virus, Pfizer-BioNTech’s rapid shift from temporary solution to permanent, branded product is a symbol of good news: like Comirnaty, the gains of our industry’s last eighteen months aren’t going anywhere.
I’m not only talking about the vaccines themselves, but about everything it took to get us here. New ways of accelerating from R&D to manufacturing. New models for partnership and collaboration. A whole new mindset, which casts off our industry’s conservative nature in favor of more innovation, more speed, and more flexibility in the name of more lives saved.
“We will one day defeat this pandemic, but the waves of change that are overtaking the life sciences are only just gaining momentum. ”
This survey is our opportunity to raise a periscope above those waves. More than 500 people answered nearly 80 questions, and their collective data revealed two intersecting trends which will define the post-pandemic era for our industry.
The first relates to the science of drug manufacturing. Clinical teams are developing novel therapies capable of preventing and curing diseases that, until now, have eluded effective treatment. We watched this happen in real time as the world’s first CRB Horizons: Life Sciences 6 mRNA vaccines emerged last year, but this scientific revolution has been in the making since before the pandemic—just look at the scale of private investment in cell and gene therapy research, which reached nearly $20B in 2020. The last eighteen months have only accelerated that trajectory; halfway through 2021, the sector is on track to shatter 2020’s funding record with $14.1B already raised. Many of these therapies will achieve regulatory approval over the coming year, further stoking the industry’s appetite for scientific innovation.
But for that breakthrough science to mature into sustainable, commercial-scale operations, we need significant changes in drug manufacturing. That explains the second trend running through our survey data: drug developers are rethinking the way our industry operates as a whole.
Dissatisfied with traditional design-bid-build methods and galvanized by the speed of our industry’s pandemic response, many project leaders are turning to much faster and more agile solutions. They’re leveraging the predictive capabilities of AI and machine learning to build smarter, more secure, and future-ready manufacturing centers. And they’re redesigning the traditional GMP cleanroom to accommodate closed and automated processes—a necessary step toward improving the cost and quality of tomorrow’s medicines.
With these macro shifts underway in both the science and the practical realities of drug manufacturing, what’s happening at a more micro level—the level of on-the-ground decisions that today’s companies make every day, around the world? To answer that question, we’ve carved this report into eight key focus areas.
Cell and gene therapies
In this article, expert Peter Walters looks at what cell and gene therapy developers can do to plan for long-term commercial success while so much change is underway at the lab bench. Drawing from our survey data, Walters takes a close look at how technologies like single-point, process-in-a-box systems will transform the future of drug manufacturing.
After decades of research, the science of oligonucleotide manufacturing is on the brink of graduating from the lab bench to the bedside—and once it does, it will change many patients’ lives. That’s why nearly a quarter of our survey respondents have oligo therapies in their pipeline, or are planning to add them in the near future. What challenges will these companies face as they approach commercial manufacturing? Join experts Bill Jarvis, Jim Love, and Brendan Nichols for their perspective.
The pandemic thrust mRNA technology into the spotlight, rapidly catalyzing years of research into life-saving vaccines. But as our survey data shows, that’s just one slender chapter in a complex story. More than one-quarter of respondents are pursuing or plan to pursue RNA therapies across a wide array of indications, from autoimmune diseases to oncology. As their pipelines mature, these companies face new questions about supply chain management, facility design, and scale-up. In this article, experts David Estapé, Ken Jacobson, Can Aktar, and Jake Adams examine these questions and help readers understand where the future of commercial RNA manufacturing may take us.
Four-fifths of our survey respondents identify their company in the top three tiers of the five-level Digital Plant Maturity Model (DPMM), and most aspire to Level 4, defined by digital facilities that leverage predictive analytics. What stands in their way and how can companies plan around those barriers to unlock the full potential of AI and machine learning? In this article, experts Yvonne Duckworth, Niranjan Kulkarni, and Matt Edwards answer that question.
Warp speed drug delivery
What began as a rallying cry to ignite our industry’s rapid pandemic response is now a permanent feature of drug delivery—warp speed, in other words, is the new cruising speed. In fact, our survey reveals that “speed-to-market” jumped from a lower-ranking business driver before the pandemic to the top priority today, overtaking cost-based considerations by a healthy margin. Experts Dominic Tate, Christa Myers, and Jarrod Wrampe explore what this “warp speed” state of mind means for companies planning their commercial scale-up strategies.
When we asked about project delivery, we noticed an interesting schism: most say that they rely on design-bid-build or design-build, and yet, in the next question, they ranked those very delivery methods as least satisfactory compared to more lean and integrated models. What’s going on? Experts Mike Barrett and Carl Rohs dive into our survey data to find out, and to help companies better match their project delivery approach with their need to move fast and maintain quality.
At CRB, we often rely on lean tools like PPMOF (prefabrication, preassembly, modularization, and offsite fabrication) to help clients meet aggressive delivery milestones. But what about the rest of the industry? Through this survey, we learned that while 70% of companies say they’re using PPMOF optimally, only a small minority consider it valuable. Chief among our respondents’ concerns: quality and cost. So, what are the facts? Can PPMOF help meet all project delivery criteria, not just speed? JP Bornholdt and Dennis Kearney provide their expert perspective in this article.
Moving from chronic treatments to one-time curative therapies is our industry’s next big innovation, but if we’re destroying our planet in the process—well, where does that leave us? That’s why it’s encouraging to see that the majority of respondents have a sustainability strategy in place. But how are different organizations using that strategy to balance the needs of the planet, the people inside their company, and their bottom line? Join experts Jeff Wegner and Maya DeHart for a deep dive on this topic.
Client deep dive: Johnson & Johnson
Meet Jim Breen, VP Lead Biologics Expansion, Janssen Pharmaceutical Companies of Johnson & Johnson. In this article, Jim reflects on his own answers to our survey questions, giving readers a rare glimpse inside one of the world’s leading life science innovators. You’ll learn about Johnson & Johnson’s approach to moving fast, managing constant change, and maintaining a strong and resilient company culture along the way.
Disruption—the harmonizing theme
Those of us who rolled up our sleeves for an mRNA COVID-19 vaccine this year may do the same for an mRNA cancer vaccine in the future. Parents will soon be able to screen for and prevent DNA risks in their children. Those whose diseases would have once shortened their lives will have access to genetically engineered therapies that could eliminate their diseases altogether. This is the future of life sciences.
These revolutionary ideas promise effective therapies and sustainable new business models, but they also introduce all-new challenges. We won’t overcome these challenges using the same old tools that served our industry in the past. To succeed, we need the willpower to undertake an honest examination of our industry, our companies, and our facilities, eliminating the systems that no longer work and making room for innovation and reinvention.
To succeed, "we need the willpower to undertake an honest examination of our industry, our companies, and our facilities, eliminating the systems that no longer work and making room for innovation and reinvention."
Instead of slow and incremental change, we need bold action. Instead of outdated checks and balances, we need delivery strategies that balance risk with progressive new ideas. Instead of competition, we need collaboration. This is how we will prepare ourselves for what’s to come. It’s the only way.
In that spirit of collaboration and progressive thinking, our team offers you this report, which consolidates the experiences and perspectives of so many from across our industry as they face a new horizon in drug manufacturing.
To access more insights on the future of life science industry, download this report.
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