For Angelica Meyer, PhD, director of manufacturing, science, and technology at Aldevron, downstream bioprocessing is both a challenge and an opportunity. As she explains, much of the complexity comes from purification—whether plasmid DNA, mRNA, or protein. “As an organic chemist, I can tell you it’s easy to make molecules. The hard part is isolating them and getting them pure,” Meyer says. “When you break open a cell, you’re left with what feels like a witch’s cauldron—cell walls, plasmids, macromolecules, all mixed together. The real challenge is pulling out the one thing you want.”
Aldevron, a global contract development and manufacturing organization (CDMO), tackles this with a mix of chemical and physical cell-disruption methods, followed by rigorous purification steps. But as Meyer notes, the real bottleneck often comes at scale. “Scaling up introduces challenges you don’t see at the bench,” she says. “Quality is everything—if that’s not right, nothing else matters.”
To address downstream inefficiencies, Aldevron embraces value-stream mapping and other problem-solving frameworks. Meyer emphasizes the importance of this approach: “Being part of Danaher has given us access to an amazing toolbox for evaluating and improving our processes.” These continuous evaluations are especially crucial as Aldevron expands its presence in the mRNA space.
Still, process improvements face unique hurdles in a heavily regulated industry. “Clients may be mid-trial with regulatory documents already filed, and making changes isn’t always possible without causing setbacks,” she says. “That’s a tricky balance—we want innovation, but we also need to respect the path our clients are on.”
Looking ahead, Meyer sees the evolution of bioprocessing as part of a broader shift in medicine. “Fifty years ago, everything was about small molecules,” she says. “Today, we’re advancing gene therapies, CAR T-cell treatments, and mRNA vaccines. What once seemed unimaginable is now reality.”
For Meyer, it all comes down to progress built on quality and persistence. “We’re not done,” she reflects. “Every step forward in bioprocessing helps bring safer, more effective therapies to patients—and that’s why we do this work.”