Automated Crystallization Platforms for Accelerated Process Development
The Use of PAT to Decipher Crystallization Mechanisms
Program Overview
- Challenges and innovation in achieving first-in-class milling and seeding automation set up
- Particle engineering case study at the drug substance and drug product interface
- Use of PAT to decipher crystallization mechanisms
Automation plays a vital role in reducing development time in the pharmaceutical industry, both for drug substances (DS) and drug products (DP). In the last two decades, many aspects of crystallization development (solubility, kinetics, solid form characterization, concentration) have been positively impacted by automation, both in hardware and data processing. However, wet milling, a critical unit operation used to manipulate particle properties in a crystallization process, has been non-conducive for automation.
This study discusses efforts towards automation of wet milling coupled with off-the-shelf automation tools for faster execution of physical property design workflows. The hardware and software configuration used, along with challenges and prospects to achieve milling automation are discussed. Lovastatin was used as a model compound to demonstrate the capabilities of the automated platform to achieve morphology and size manipulation. The on-demand milling platform combined with data-rich trials using PAT is estimated to accelerate process development for particle engineering and reduce the drug substance delivery time to the drug product team.
About the Presenter
Shailesh Agrawal
Postdoctoral Scientist (Automated Crystallization) - Eli Lilly and Company
Shailesh Agrawal is currently working as a postdoctoral research scientist in the Particle Design Lab within the synthetic molecule design and development department of Eli Lilly. He completed his PhD at Massey University, New Zealand, and his Masters at the Institute of Chemical Technology, Mumbai University. He is currently working on automation opportunities to accelerate crystallization process development in an industrial setting. Shailesh has extensive experience in the field of crystallization, both experimental and modeling, over a decade-long research and academic career.
