Process-Related Impurity Detection​

In biopharmaceutical manufacturing, process-related impurities can come from a wide range of raw materials, equipment and other materials that encounter the product during upstream and downstream operations. Because these impurities can be potentially impact product quality and patient safety, removal of these impurities during the purification process becomes critical and thus, detection and quantification of known impurities becomes one of the key Quality Control release measures for both drug substance and drug product.

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The WuXi Biologics Center of Excellence for Process Related Impurity Detection utilizes state-of-the-art instrumentation and provides the expertise to develop custom methods and we also provide a comprehensive range of pre-existing assays to detect common process-related impurities. Our team of experts and highly-trained assay development and QC scientists have supported over 150 CMC projects currently in clinical trials and 14 marketed products for a variety of biologics that include polypeptide, monoclonal and bispecific antibodies, fusion proteins, enzymes and other recombinant proteins.