When it comes to Active Pharmaceutical Ingredient (API) development, success doesn’t stop at discovery—it hinges on scale-up. At Olon USA, scale-up isn’t just another step in the process; it’s our specialty. Whether it’s translating a promising MedChem route into a viable manufacturing process or solving the filtration challenges that threaten timelines, Olon USA helps innovators transition from lab-scale discovery to full-scale API production—efficiently, reliably, and creatively.
From Lab Bench to Large-Scale Production: Where the Real Work Begins
When a new project enters the doors at Olon USA, our process chemistry team begins with a deep evaluation of the synthetic route. Most often, these compounds were developed using medicinal chemistry (MedChem) approaches that allow for small-scale synthesis but present roadblocks at scale.
One of the first tasks is identifying what can’t scale efficiently. Purifying materials via prep HPLC at scale is an obvious problem, but more subtle problems often exist. Does the compound degrade if there are extended hold times at any point in the process? Is the product a sticky solid that will be difficult to remove from the reactor and filter poorly? Do different polymorphic forms exist for the compound, and is the most thermodynamically stable form being used? Is there a possibility for emulsions to be formed during phase splits?
Our process chemists initially screen the synthesis process for any areas that could present processing difficulties at scale. They work closely with our process technology transfer manager and the specific chemical engineer assigned to the project to ensure that all areas of potential concern have scalable solutions implemented before the process is transferred to the KiloLab or Plant facilities.
Addressing the Hidden Headaches of Scale-Up
What works in a flask often fails in a 2,000-liter reactor. Solids that filter well in a lab might form dense, sticky cakes during scale-up. As our team puts it, “we’d rather filter sand than peanut butter.”
That’s why we implement strategies like Ostwald ripening to increase crystal size and improve filtration, saving not just hours—but days—at scale. We also examine hold times, phase separation speed, thermal stability, and distillation efficiency using tools like Dynochem modeling software to anticipate and solve problems before they happen.
Why Scale-Up at Olon USA?
Plenty of CDMOs offer scale-up, but few make it their core competency the way Olon USA does. Our KiloLab allows flexible, efficient scale-up from 10 to 200 liters, reducing the trial-and-error typically required for process transition. We can also move directly into full-plant batches ranging from 40 to 2,000 liters.
This flexibility and experience make a difference. Our engineers and chemists work side by side to design and execute strategies tailored to each API. It’s not about throwing more people at a problem—it’s about solving it the right way. That’s why our clients keep coming back.
Creative Chemistry That Delivers
We pride ourselves on offering innovative, practical solutions where others offer band-aids. One notable example involved a client who had previously struggled with multiple partners to scale a challenging process. Our team not only adjusted the route but scaled it to 25 kg production—successfully, repeatedly, and without major issues. That case study now lives as a testament to our process development capabilities.
Ready to Scale Your API?
At Olon USA, we’re not afraid of difficult chemistry. In fact, we thrive on it. Whether you’re struggling to scale a complex molecule or just want to ensure your project transitions smoothly from discovery to GMP production, we have the tools, talent, and tenacity to make it happen.
Want to see how we do it? Check out our case study on challenging chemistry scale-up or reach out to our team today to get started.