Meeting the PSD Specification was Crucial for Achieving Business Goals.
The process transfer was overseen by a team consisting of process operators, particle engineers, project managers, and technicians. On the manufacturing side, process operators, engineers, and a project manager contributed. They faced the typical challenge of ensuring transfer success with no knowledge of the target reactor's fluid dynamic properties. Success was defined as meeting drug substance specifications in a specific time frame using one of the manufacturing company's proposed reactors. The particle size distribution (PSD), affected by fluid dynamics, was the key specification.
Several reactors were suggested by the manufacturer. Novalabs assisted in choosing a reactor with fluid dynamics that would satisfy the PSD requirement. We utilized our specialized computational framework, designed for comparative reactor studies in pharma crystallizations, to accomplish this.