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A well characterized biopharmaceutical product is defined during its development by identification and quantification, if possible, of both process and product related impurities. Process and product related impurity testing can be used to show purity, batch to batch consistency and demonstrate the removal of certain impurities during the manufacturing process.
Process related impurity analysis
Capabilities include isolation and detection of process related impurities such as host cell proteins, inducers (IPTG), antibiotics (kanamycin, chloramphenicol), and those related to downstream processing (dithiothreitol, DCA, heavy metals and TCEP) from diverse matrices. This is achieved by using a range of in-house analytical techniques and instrumentation including GCMS, HPLC with UV detection, LCMS, LC-MS/MS, NMR, ICP-MS and UV assay.
Intertek is highly experienced in the development, verification and validation of methods for process related impurity analysis, in accordance with ICH Guidelines Sections Q2(R1) and Q6B. All work is subjected to internal QA audit and review upon request, and is performed using state-of-the-art instrumentation. The laboratory is both GLP and cGMP accredited.
Product related impurity analysis
Intertek has built a strong track record analyzing product related impurities in connection with proteins, peptides and oligonucleotides. Product related impurities are characterized and quantified using an array of separation techniques including ion exchange, size exclusion and reverse phase chromatography. The high specificity and sensitivity of UV and mass spectrometer detectors allows for detailed characterization and quantitation of low level impurities.
Request more information to see how Intertek can help your organization with Process and Product Related Impurities Analysis.
