2024 AIChE Annual Meeting
(184c) Need Big Particles but Have No Time? Rapid Development & Scale-up of Spray Drying to Control Particle Size
API clinical manufacturing of early-phase assets is often fraught with tight timelines, unexpected deviations, and the need for prompt development solutions. The need for flexible, easy-to-perform experiments is critical to maintain schedules and prevent project delays. With that in mind, the team developed a workflow designed to rapidly understand how to control particle size through spray drying using minimal development conditions. This was necessary in order to reprocess amorphous API to the original particle size and supply material in time for clinical trials. Through literature and internal expertise, key parameters were identified and tested via a lab-scale unit before scaling up to the manufacturing spray dryer. With only two days of development time on the manufacturing equipment prior to clinical spray drying, the new workflow was implemented. After changes to the fluid cap size and visual confirmation of acceptable atomization across a range of atomization nitrogen pressures, three small batches were spray dried at minimum, maximum, and standard atomization pressures. By fitting a trend to the data, an atomization flow rate was calculated to achieve the target particle size for the clinical batch. A final test run showed acceptable particle size and residual solvent levels, which enabled clinical processing to start and delivery of amorphous clinical-grade reprocessed API without further project delays.