Detection and Quantitation of Process-Related Impurities in Biopharma Manufacturing

By Syngene International

Detection and quantitation of process-related impurities is an important part of quality control in biopharma manufacturing. Process-related impurities can significantly impact a pharmaceutical product's quality, safety and efficacy.

These impurities may get generated during the manufacturing process, degradation, starting materials and reagents by products, storage conditions or contamination. If not properly detected and quantified, these impurities can lead to adverse effects on patients.

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