Isolation and Characterization of Product-Related Impurities

Intertek offers an efficient and robust biopharmaceutical purification suite to assist in the isolation and subsequent characterization of product-related impurities.

As part of a biopharmaceutical process validation, it is necessary to fully characterize product-related impurities.  Often milligram quantities of each significant process related impurity are required to fulfill the material requirements for characterization studies and validation of QC release methods.

Intertek employs the Akta™ Fast Protein Liquid Chromatography (FPLC) system to develop a semi-preparative scale ion exchange chromatography method in order to purify acidic and basic species relating to a monoclonal antibody. Using the optimized method, collected fractions from several chromatographic runs can then be pooled, buffer-exchanged and concentrated to mg/ml levels. Each purified batch is subjected to an internal QC check by SDS-PAGE, A280, IEF and ion exchange chromatography.

We can also offer a similar approach with the Agilent 1200™ system to scale-up a size exclusion chromatography method in order to purify aggregates and structural variants of the product.  Native PAGE, A280 and size exclusion chromatography can then be employed to check the quality of the batches purified in milligram quantities.

Further characterization can be conducted using a diverse range of technologies and instrumentation within Intertek (MS, HPLC, IR, NMR, fluorescence, ELISAs and electron microscopy - TEM and SEM).  We assign a project manager to manage complex characterization studies which are subject to QA audit and review upon request.
 

Request more information to see how Intertek can help your organization with Isolation and Characterization of Product-Related Impurities.