In the last decade, high-resolution mass spectrometry (HRMS) has emerged as a powerful technique in many fields of biological studies, pharmaceutical and nutraceutical research and environmental analysis.

Thanks to the high resolution and accuracy in results, targeted and untargeted analysis and structural information obtained by MS in tandem analysis, the QTOF-MS instrument has been widely exploited for comprehensive drug screening in biological samples.

Olon uses a well-established technological platform to produce peptides via a recombinant approach that involves strain design, construction and improvement, as well as fermentation and downstream process design and optimization for the isolation and purification of peptides as active pharmaceutical ingredients (APIs).

The process, and particularly the purification step, must ensure not only consistent quality through all batches, but also the safety and efficacy of the final product. To this end, this whitepaper shows how a HRMS method can be used to identify and characterize unknown impurities in samples of recombinant peptides.