Most laboratories use Size Exclusion (SEC), Ion Exchange (IEX) and Reversed-Phase chromatograph (RP HPLC) as part of a their protein characterization analysis. However, the chromatography may sometimes leave you with questions about the identity of product related impurities, expressed as specific peaks and shoulders in your chromatogram.
A molecular weight analysis of the peaks by mass spectrometry will often identify the molecule. For reverse phase HPLC you can simply connect the HPLC to a mass spectrometer to answer such questions. Combining SEC/IEX directly with mass spectrometry is not as easy due to the buffers used for IEX and SEC.
We can now help you with detailed analysis of the unknown product related impurities expressed as new peaks and shoulders in your chromatogram. You simply transfer your SEC/IEX/RP HPLC analysis method to our laboratory. We will then collect fractions – and after off-line sample prep we can characterize the fractions by mass spectrometry.
Optimize the process development of your drug product – identify product related impurities
We recently invested in a new Agilent 1290 system equipped with fraction collector, UV and fluorescence detector. With the new equipment, we can now combine SEC/IEX analysis with detailed characterization of individual peaks for identification of product related impurities, including:
The information from these analyses are crucial for intelligent optimization of your process development.