Every medicine begins with a molecule – but it’s only at scale that it gains real power.
Only then do questions of safety, reproducibility, efficiency, and regulatory compliance arise. That’s when science begins to work for the benefit of the patient. At Łukasiewicz – ICI, we manage this process from start to finish. How do we do it? We hand the floor to Piotr Zaleski PhD from the Department of Pharmaceutical Products.
Why is scale-up one of the most challenging stages in drug and API development today?
Because scale changes everything. Something that worked perfectly in a laboratory flask may behave completely differently in a 5-liter reactor – and even more so in a pilot plant. Reactions that are safe and efficient on a small scale can become unstable, hard to control, or simply uneconomical at larger volumes. That’s why scale-up isn’t just about “making it bigger,” but about achieving an entirely new quality – with new parameters, conditions, and expectations. We’re here to guide our partners through every step of this process.
Where does it all start?
It starts with excellent chemistry. Our team designs synthetic path with production in mind – not just for publication. Already at the research stage, we look for solutions that can be implemented: suitable reagents, optimal temperatures, pressures, solvents, and process sequences. In parallel, we develop analytical methods and control every stage of the work. Thanks to this, we already know in the laboratory which paths make sense and which – although scientifically interesting – are not promising on an industrial scale.
And then comes the infrastructure?
Exactly. We have facilities that allow a seamless transition from lab samples to pilot-scale production – from micro-flasks to installations comprising reactors of several hundred or even over a thousand liters, operating under GMP conditions. This means we can not only test reactions on a larger scale but also produce full batches of substances for registration purposes or clinical trials. Importantly, all this takes place in one location, handled by one team, under full quality control.
So you provide not only know-how, but also the product?
Yes – and that’s our advantage. The client receives not only a developed method but also an actual batch of starting material or active substance, ready for registration. With documentation, certificates, and a complete analytical trace. We also support technology transfer – if someone wishes to continue production independently or with a contract manufacturer (CM), we prepare the process so that it is easy to reproduce and validate.
What projects are most interesting to you?
Definitely the difficult ones – such as sensitive compounds, multi-step syntheses, cases requiring extreme purity or controlled polymorphism. Recently, for example, we have been working with cladribine, developing it both as an API and a finished product, and also on oseltamivir. These are molecules of enormous therapeutic significance that require precision and experience. In the case of cladribine, we can speak not only of advanced technology but also of a systemic achievement – because thanks to our medicine Biodribin®, used in the treatment of hairy cell leukemia (HCL), Poland has achieved full self-sufficiency in this therapeutic field. From API synthesis, through formulation development, to the production of the finished product – we do everything ourselves, here in Poland, in accordance with the highest standards. This shows how important a well-executed project can be: not only for the market but also for the healthcare system and patient safety.
Will the Mościcki Campus change anything in terms of scaling?
It will bring a major transformation. At the Mościcki Campus, currently under construction with funding from the Polish Recovery and Resilience Plan (KPO) – a project worth PLN 240 million, will host a dedicated API Manufacturing Technology Center. This will allow us to execute projects even faster and more efficiently. It will be truly state -of-the-art in practice – and with tremendous export potential.
And one last question – where can we meet you?
You can meet us at CPhI Frankfurt 2025 – booth 3.0K72T. We’ll be there with our team, our ideas, and fully developed technologies. If you have an idea, an API, or a project that’s stuck at the lab stage – come see us. We’ll show you that the path from the laboratory bench to full-scale production can be shorter than you think.
