Noel Maestre, PE, vice president of Life Sciences, and David Estape, technology manager Biotechnology at CRB discuss how virus response rewrote the playbook for vaccine response, but even more change is necessary to deal with emerging threats.
Across the world, governments and biopharma organisations are absorbing the lessons of the Covid-19 pandemic. With much of the world now in endemic protocols – managing the virus, yet wary of variants potentially in wait - there is an enormous amount to understand about what worked, and what didn’t, in the race to deliver effective life-saving vaccines and therapies.
As we move toward virus management, we marvel 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 favour of more innovation, more speed, and more flexibility with the goal of more lives saved.
As the Omicron variant emerged in late 2021, CRB released its newest Horizons: Life Sciences report, built with an exhaustive survey of more than 500 industry leaders who answered nearly 80 questions. The resulting data revealed two intersecting trends which will define the post-pandemic era for our industry.
First, the science of drug manufacturing: Clinical teams aredeveloping 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 mRNA vaccines emerged last year, but it’s a shift long in the making; consider the scale of private investment in cell and gene therapy research, which reached nearly $20 billion in 2020 and subsequently $23 billion in 2021. The last 24 months have only accelerated that trajectory.
Second, a radical reconsideration of the way drug developers think about how our industry operates.
Dissatisfied with traditional design-bid-build methods and galvanised 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 centres. 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?
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 finds 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. We reveal what this “warp speed” state of mind means for companies planning their commercial scale-up strategies.
CELL AND GENE THERAPIES: We examine 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, Peter Walters takes a close look at how technologies like single-point, process-in-a-box systems will transform the future of drug manufacturing.
RNA TECHNOLOGIES: The pandemic thrust mRNA technology into the spotlight, rapidly catalysing years of research into life-saving vaccines. But as our survey datashows, 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.
THE NEW WORLD OF 4.0: Four-fifths of our survey respondents identified their company in the top three tiers of the five-level Digital Plant Maturity Model (DPMM), and mostaspire to Level 4, defined by digital facilities that leverage predictive analytics. We explored the obstacles to unlocking the full potential of AI and machine learning.
OLIGONUCLEOTIDES: 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?
LEAN DELIVERY: 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. How can companies better match their project delivery approach with the need to move fast and maintain quality.
SUSTAINABILITY: 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 havea sustainability strategy in place. But how are different organisations using that strategy to balance the needs of the planet, the people inside their company, and their bottom line? Disruption is the only constant.
For all its bleakness, the Covid-19 pandemic showed what was possible when industries unite. Those of us who rolled up our sleeves for an mRNA Covid-19 vaccine may do the same for an mRNA cancer vaccine in the future, and we have the playbook to move smart, safe and fast. And February’s latest scientific breakthrough of the first CRISPR edited heart transplant spells very promising implications for the future of in-vivo gene editing. Those whose diseases would have once shortened their lives will have access to genetically engineered therapiesthat 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. 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.