Biopharmaceutical Product Related Impurities Analysis
Intertek offers highly sensitive analytical solutions to enable detection and measurement of product related impurities and detailed analyses of product variants.
A well characterized biopharmaceutical product is defined during its development by identification and quantification of both process and product related impurities.
Biopharmaceutical Product Related Impurity Analysis Services
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.
Intertek has particular strengths for proteins and glycoprotein product related impurities. Our characterisation packages offered in line with the requirements of ICH Q6B incorporate stregic approaches for product related impurities including degradation products such as deamidation, oxidation and mis-matched S-S bridge forms.
Related Protein Product and Process Support Services
Request more information to see how Intertek can help your organization with Biopharmaceutical Product Related Impurities Analysis.