Continuous futures, Bayer’s BO-designed HTE and IND dance moves

INTRODUCTION

Dear Community,

We’re excited to kick off 2026 by sharing the inaugural issue of Synthesis – Cambrex’s monthly collation of science, insight and perspectives from across the field of drug development and manufacture.

For chemists out there, the word “synthesis” has a distinct meaning. And though the name of this newsletter was inspired by our work in the lab and in the plant, it also reflects our hope that sharing questions, ideas and concepts here leads to new thoughts, opinions and even solutions.

As Chief Scientific Officer, there is one question that drives me forward – and occasionally keeps me awake at night: “Do we have the right technologies in place for tomorrow’s demands?” The continually increasing molecular complexity of drug candidates and development of new modalities as therapeutics require constant evolution of our capabilities.

We genuinely want to help partners move drugs forward, and I feel personally obliged to seek out and fill potential gaps in our capability to make that happen.

In an attempt to predict the future(!), my team and I are constantly reading peer review journals and sharing advancements in chemistry with each other – and we’ll start sharing them here, too (see THE CATALYST below).

One distinct advantage for the scientists and engineers at Cambrex is our regular interaction with innovators at their earliest stages of development. It’s akin to having a crystal ball. Working on molecules as they emerge from our clients’ medicinal chemistry labs puts us in touch with the latest advances in drug discovery. With that precious insight, we’re able to start brainstorming potential solutions or exploring novel technologies to help us stay ahead of the curve.

We want Synthesis to be a bi-directional endeavor. So, what are you reading? How do you predict the future? What keeps you awake at night?

We’d love to hear from you – just hit reply.

Until next time,
Matt Bio

THE LEAD REACTION

Wrangling the golden triangle

Towards the end of 2025, three Cambrex leaders discussed a topic that will be front of mind for many as we enter 2026: “Strategic solutions for cost, time and quality challenges in drug development.”

The full discussion is available here, but to whet your appetite, we share the reactions of our trio of experts to a live poll, which challenged the audience to select the single most significant aspect of the golden triangle (cost, time or quality) in drug development.

Notably, time (46%) ranked well above both quality (33%) and cost (21%).

Derek Koops, VP & General Manager, Cambrex Longmont: “I’m a little surprised to see cost coming in at number three in the current challenging funding environment! When I think about the successful innovators we work with, they tick three boxes. First, they are honest about their business objectives and stick to that plan. Second, they develop aggressive but achievable timelines that reflect the business objectives – whether that’s short-term goals (speed to the next phase) or longer-term goals (speed to commercialization). Third, they embrace a fast and flexible product development pipeline, which means minimizing complexity and selecting partners who can pivot to address the unexpected.”

Dan Bowles, Ph.D., VP & General Manager, Cambrex High Point: “Time, quality and cost are all important, of course, and we treat them as such. To Derek’s point, in the early development space, flexibility is important, and I’d say that quality has to be woven throughout the whole process. In the production plant setting, we do need to be nimble from a clinical perspective, but we must also focus on developing a robust development package to prepare the client for that next clinical milestone so they can rapidly accelerate into the next phase.”

Matt Bio, Ph.D., Chief Scientific Officer, Cambrex: “Building on what Dan said, there is an opportunity during development into the pilot scale to invest in understanding the process. Time spent on process development at this mid-phase can save you tremendous costs and reduce potential liabilities at commercial scale.”

Watch the full discussion

THE METHOD

The past, present and future of continuous manufacturing (CM)

While other industries adopted continuous manufacturing a century earlier, pharmaceutical manufacturing remained predominantly batch-based until 2007, when the establishment of the Novartis-MIT Center for Continuous Manufacturing marked a turning point. Aiming to apply CM to both drug substance and product, the initiative spawned numerous R&D efforts across academia and industry. In the nearly two decades since the founding of the Center, CM has moved from R&D curiosity to established manufacturing technology.

In Continuous manufacturing: An evolving technology for drug substance manufacturing, Matt Bio takes us from this early ambition through to the modern-day challenges driving CM application. Specifically, he explores five examples: i) manufacturing via unstable organometallic intermediates, ii) the ability to safely scale-up synthetic routes that involve energetic, hazardous or unstable reagents, iii) high-temperature, short-duration reactions in process-friendly solvents, iv) scalable photochemical processes, and v) the use of pervaporation to selectively remove ethylene and drive ring closing in metathesis reactions.

Read the full article

ANALYZE THIS

In the roundtable discussion featured in THE LEAD REACTION, our three leaders explore the persistent need for speed – but note that aggressive timelines should not become unachievable timelines.

In Two Steps Forward, One Step Back: The Dance Toward IND Submission In Early Development, experts with diverse perspectives also debate the ramifications of aggressive timelines – especially in the early stages when little may be known about the molecule and its unique requirements.

Tracy Milburn, Executive Director of Analytical Services at Cambrex Longmont, says that a failure to take the unexpected into account is a common mistake made by innovators – particularly in terms of analytical development. “The analytical team has to keep up with changes both on the process chemistry side as well as on the product development side, and I think there is a tendency to believe that once the analytics are done, it’s done,” she explains. “However, every change in process or dose increase or decrease needs to be re-vetted to make sure the methods continue to be scientifically sound.”

In other words, delays are almost inevitable, which points to the importance of both flexibility and proximity.

Learn more in the full article

THE CATALYST

What we are reading

Data Science-Assisted Workflow for Reaction Optimization in Process Chemistry (January 8, 2026). Scientists at Bayer report on the combination of Bayesian optimization (BO) with high-throughput experimentation (HTE) to efficiently identify optimal conditions for Ullmann-type cross-coupling. The authors report on the application of BO-designed HTE in greatly reducing the number of experiments required to explore a huge, multi-dimensional reaction space. Though many others have explored similar BO-assisted HTE approaches, unique to this publication, the Bayer team then used a custom visualization tool to make clear both the results and the algorithm’s decision-making process.

THE SIDEBAR

As CEO at Snapdragon Chemistry, one thing I was really passionate about was helping to deliver technology to our clients. I found the day-to-day science – listening to problems and presenting solutions – exciting. And that’s the role here as CSO: to help solve technical problems across the organization and with our clients.