Attempting to monitor an opaque, crystal slurry presents challenges, especially when manufacturing specifications call for a tight particle size distribution (PSD). For injectable protein crystal formulations, the PSD can greatly influence viscosity as well as serving as an early warning for aggregation or other degradation events that can potentially compromise the formulation. In situ monitoring was used in a scale-up batch crystallization study to characterize human growth hormone (hGH) crystal formation and growth. Analysis detected a deviation from the usual PSD profile in real-time, caused by differences in mixing between the vessels, which agreed with subsequent offline Image Analysis (IA) particle sizing.
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David Doerner has several years of process development experience working with proteins from fermentation through purification to batch crystallization. His experience ranges from the bench to pilot plant scale at Ajinomoto Althea, BP Biofuels, and UCSD. He is currently a subject matter expert in crystallization scale up, automation, statistics, and analytics in the Crystalomics Department at Ajinomoto Althea. He received his undergraduate degrees in Biochemistry and Management Science from Univerrsity of California - San Diego, where he is currently completing a Masters Degree in Data Science and Engineering.