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Amorphous or Crystalline? Using Next Generation PAT to Track API Particle Attributes for Enhanced Downstream Processability

By Richard Becker, BlazeMetrics   Process Analytical Technology (PAT) has dramatically expanded its capabilities over the last decade. Today’s PAT enables an in-depth understanding of process behavior on both macroscopic and molecular levels, allowing users to accurately track the impact of process variables on system behavior. Whether in a reactor, a continuous flow line, or a filter/dryer, kinetic mechanisms such as nucleation, growth, breakage, agglomeration, and “oiling out” play a major role in downstream drug product manufacturing. Using next generation PAT, these mechanisms are understood in real-time such that they can be related to final crystal morphology, surface, size, and structure, which ultimately drive downstream processability.   In this talk, I will review the enabling improvements to the PAT landscape as they relate to crystal manufacturing and provide examples of how those improvements deepen process understanding, speed process development and in some cases enable new paths to process optimization.
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