Process related impurities definition

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Definition

Process related impurities are contaminating chemicals in a biopharmaceutical sample originating from the production process itself (e.g. nutrient media, initiators of protein production and selection, chemicals used in the subsequent purification) or chemical modifications to the product (e.g. PEGylation).

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Case Study

Sekisui – Method Development for a Process Related Residual

An on-line LC/ES-MS method for pDADMAC analysis was developed. Initial mass spectrometric investigations identified key ions shown to be suitable for a quantitative analysis of pDADMAC through a Multiple Reaction Monitoring approach.