Visible particle identification is a crucial prerequisite step for process improvement and control during the manufacturing of injectable biotherapeutic drug products. Raman spectroscopy is a technology with several advantages for particle identification including high chemical sensitivity, minimal sample manipulation, and applicability to aqueous solutions. However, considerable effort and experience are required to extract and interpret Raman spectral data. In this study, we applied machine learning algorithms to analyze Raman spectral data for visible particle identification in order to minimize expert support and improve data analysis accuracy. We manually prepared ten types of particle standard solutions to simulate the particle types typically observed during manufacturing and established a Raman spectral library with accurate peak assignments for the visible particles. Five classification algorithms were trained using visible particle Raman spectral data. All models had high prediction accuracy of >98% for all types of visible particles. Our results demonstrate that the combination of Raman spectroscopy and machine learning can provide a simple and accurate data analysis approach for visible particle identification.
Keywords: Injectable; Machine learning; Particle identification; Processing; Raman spectroscopy.
© 2022. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.