Case Study | Particulate Matter in an Injectable Drug Product

Particulate contamination is a critical quality attribute for any pharmaceutical. In this case study, our expert, Dr Peter Muehlschlegel describes the steps of an investigation into the occurrence of foreign particulate matter (FPM) in a lyophilised drug product. The composition of FPM was identified through the application of microscopy and spectroscopy techniques which helped to confirm the origin of the particles. The insight from this study then helped to de-risk the production process in relation to FPM.

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