Process Development
Process Development for Precision, Control, and Manufacturing Readiness
We transform laboratory scale chemistry into robust, reproducible, and successful processes for material supply, delivering data-driven solutions that ensure your process performs from discovery through manufacture.
- Overviews
- Process development and scale-up
- What you can achieve
- FAQs
Moving from laboratory success to reliable, large-scale manufacture is one of the most critical transitions in drug development. Yield variability, impurity control, and process robustness can all derail timelines and costs.
At CatSci, we combine scientific rigour with practical execution to design processes that perform in the real world. Our multi-disciplinary teams work at the intersection of chemistry, analytics, and engineering to optimise every step, ensuring efficiency, safety, and sustainability.
What You Can Achieve
Frequently Asked Questions
Pharmaceutical process development is the design and optimisation of chemical processes to reliably manufacture a drug substance or product at scale. At CatSci, we develop robust, efficient, and sustainable processes that ensure consistent yield, purity, and safety from discovery through to GMP manufacture. Our approach integrates chemistry, analytics, and engineering for full lifecycle control.
CatSci ensures scalability through data-driven experimental design, pilot-scale testing, and cross-functional collaboration. Using statistical-led optimisation (Design of Experiments, Bayesian optimisation, or traditional methods), we optimise reaction conditions, impurity control, and process robustness. Each step is stress-tested under manufacturing conditions to deliver reliable, reproducible performance across scales.
Yes. CatSci delivers ICH Q14-aligned documentation and complete tech-transfer packages for every project. Our pharmaceutical process development services include validated analytical data, impurity lifecycle mapping, and transparent decision records — ensuring smooth partner handovers and regulatory confidence.