API Manufacturing Process Development Steps: From Filtration to Finishing

Developing an active pharmaceutical ingredient (API) is a lengthy process. It begins in a lab and ends with a finely tuned, highly regulated product ready for formulation and patient delivery. Between these two points lie a series of critical process development steps, each with its own challenges, regulatory demands, and opportunities for optimisation. That’s where API process development makes all the difference.

At Powder Systems Limited (PSL), this development process is supported every step of the way. With decades of experience in process development, PSL provides engineered systems that help pharmaceutical companies transition from small-scale research to large-scale manufacturing. From filtration to finishing, our solutions are designed to support every development phase, ensuring consistent quality, efficiency, and safety.

Let’s explore how we help transform starting materials into pharmaceutical products, guiding the production process from the lab bench to the commercial plant.

Effective pharmaceutical process development begins with scalability in mind. PSL’s modular systems are specifically designed to replicate and scale processes from pilot plants to full production. This flexibility is essential, especially when transitioning from initial R&D work to manufacturing clinical batches or preparing for commercial production.

Our modular systems—used for everything from bench-top research to pilot-scale runs—are designed for consistency. The logic is simple: what works in the lab should work in the plant. By supporting seamless transitions across development stages, PSL helps ensure that critical process parameters stay intact as batch sizes grow.

This scalability isn’t just convenient—it’s essential. Regulatory approval hinges on reproducibility, and PSL’s equipment provides the consistency needed to hit that mark at every scale.

After identifying promising drug candidates, the first practical step in the API manufacturing process is typically solid-liquid separation. This is where the active compound is separated from the reaction solvent and by-products—a critical stage in both chemical and pharmaceutical process development.

PSL’s Agitated Nutsche Filter-Dryers (ANFDs) are engineered to handle this with exceptional control. These systems allow operators to carry out multiple functions—filtration, washing, and drying of high value materials—within a single unit. For early-stage development, PSL’s GFD®Lab unit offers this same capability on a small scale, ideal for research settings and pilot plant applications.

By minimising product loss and exposure risk, these systems help ensure that API process development remains efficient and safe, no matter the stage of scale-up.

Once separated, the API must be dried without compromising its chemical stability or purity. This is a sensitive point in the manufacturing process, particularly for APIs that degrade under heat or oxidation. Despite their general applicability in this area, ANFDs aren’t the only solution for API drying and sometimes materials require static vacuum drying.

PSL’s CakeStand™ Vacuum Tray Dryers meet this challenge head-on. With vacuum-assisted drying and uniform shelf heating, they provide the low-stress, high-efficiency conditions that are crucial for preserving drug substance quality. These systems are not only energy-efficient—they’re also highly programmable, ensuring consistent drying performance across multiple batches.

For pharmaceutical process development teams, this kind of automation and precision makes regulatory validation far easier to achieve and maintain.

No process is complete without validation. And in the pharmaceutical industry, this doesn’t just mean checking a box—it means proving your process works exactly as expected, under every condition, prior to its release.

We take this seriously. Our Factory Acceptance Testing (FAT) procedures go beyond a basic function check. Every piece of equipment is tested for physical integrity, control logic, automation performance, and overall operability before it ever ships to the client’s site.

Why do this upfront? Because once equipment is installed on-site, any unexpected issue becomes harder (and costlier) to trace. Our thorough validation helps teams start strong and stay compliant, without delays or surprises.

This is reinforced by Site Acceptance Tests (SAT) that are more reflective of site-specific factors and integration with existing systems in the actual operating environment.

As your API approaches the finish line, attention shifts to physical characteristics—particle form, moisture content, and overall purity. These factors will affect everything from formulation compatibility to shelf life.

PSL designs our systems with these finishing requirements in mind. From final drying to contained transfers, every step is optimised to protect product integrity while reducing manual handling. cGMP-friendly features like easy-clean designs and sealed connections help ensure your API exits the production line just as pure and potent as it needs to be.

PSL’s contribution doesn’t stop at manufacturing. We’ve earned industry recognition—notably the ACHEMA Innovation Award and multiple Queen’s Awards—for continuously pushing what’s possible in process engineering. Our focus on innovation, from containment strategies to software integration, positions us as not just equipment providers, but as true partners in pharmaceutical progress.

API process development is complex. Every step, from filtration to finishing, presents unique technical challenges—but also enormous opportunities for refinement and control. With a partner like Powder Systems Limited, developers gain more than just equipment—they gain a proven process roadmap, shaped by decades of expertise and driven by continuous innovation.

For pharmaceutical teams looking to scale with confidence, PSL offers the tools and the insight to get there.