Intertek ASG Laboratory, Manchester, UK

Biopharmaceuticals:

Product Related Impurity Isolation

As part of biopharmaceutical process validation it is necessary to fully characterize product related impurities. Often milligram quantities of each significant process related impurity are required to fulfil the material requirements for characterization studies and validation of QC release methods.
 
Intertek ASG offers an efficient and robust biopharmaceutical purification suite assisting in the isolation and subsequent characterization of biopharmaceutical related impurities.

In a recent study Intertek ASG used an in-house 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, fractions were collected from several chromatographic runs, then pooled, buffer exchanged and concentrated to mg/ml levels. Each purified batch was subjected to an internal QC check by SDS-PAGE, A280, IEF and ion exchange chromatography.

Intertek ASG have performed a similar study using an Agilent 1200 system to scale up a size exclusion chromatography method to purify aggregates and structural variants of the product. Native PAGE, A280 and size exclusion chromatography were used to check the quality of batches, purified in milligram quantities.

Further characterization can be carried out using a diverse array of qualified instrumentation and techniques within Intertek ASG. These include mass spectrometry, HPLC, infra-red, NMR, fluorescence, ELISA’s and electron microscopy. Complex characterization studies are project managed in-house and are subjected to QA audit / review upon request.

asg.nwtc@intertek.com

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Email ASGlab@intertek.com for more information