Dr. Carmen Guguta, global head of business development and marketing, Technobis Crystallization Systems, describes the time-consuming challenges of current crystallisation process and how innovative analytical instruments are massively reducing the time it takes to develop drugs to market-ready status.
Key insights:
- HPLC is a time-consuming process as the equilibration and experimentation phases require days to generate one solubility figure.
- The pressures involved with HPLC, the expensive solvents needed to run assays, and machine maintenance costs are all considerations researchers must make.
- Advanced analytical instruments have reached the lab apparatus market, allowing quicker, more cost-effective solutions for mitigating the risk inherent to drug development.
A drug’s journey to fully approved, market-ready status is a long one. After identifying an active pharmaceutical ingredient (API), chemists must determine the best way to administer it, and the most stable morphology for industrial-scale manufacturing and storage in different conditions. Pre-clinical and clinical phase trials, regulatory approval and manufacturing all contribute to a process that takes years from start to finish.