This is the fifth in a five-part BioPharma Blog Series.
Have you ever wondered how advanced scientific techniques can unveil hidden impurities in the biopharmaceutical world?
Liquid chromatography high-resolution mass spectrometry (LC-HRMS) is one such cutting-edge method gaining traction in untargeted screening and identification of small-molecule impurities, particularly leachables from container closure systems.
In contrast to controlled extractables studies, leachables studies are carried out on the final drug formulation, where the presence of the protein drug matrix, containing relatively high levels of the active protein(s) and excipients, presents an analytical challenge for LC-HRMS analysis. Due to this complexity, confident proposal of unknown compound structures typically requires high-resolution mass spectra with MS2 and MSn fragmentation.
At a recent USA based conference, a poster was presented that detailed how the Thermo Scientific Vanquish Horizon UHPLC system coupled to a Thermo Scientific Orbitrap Exploris 240 MS compared to a typical LC-QTOF screening method, and the results are available for you to view.
Download our free impurities poster now.
Related information
Blog 1: Revolutionizing Host Cell Protein Detection and mAb Analysis in Biopharmaceuticals
Blog 2: Poster Series: A Journey into the World of Biopharma Column Chemistry
Blog 3: Take a Step Closer to Unlocking Full Potential of AAV Gene Therapy – Download the Poster
Blog 4: Unlocking the Future of Medicine: Exploring Therapeutic Oligonucleotides
Download our conference posters to see how we applied advanced analytical technology to achieve the best results for oligonucleotide analysis
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