The stability and purity of biotherapeutic formulations can impact the safety and efficacy of the product and is therefore a major concern for pharmaceutical regulators. Aggregation of proteins and the presence of contaminants are two leading causes instability and impurity. The combination of static microscopy and Raman spectroscopy in the Morphologi® ID enables automated chemical identification of protein aggregates and other contaminants in a biotherapeutic sample, either in suspension via a thin-path wet cell or on a filter membrane.
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