BioPharm International - July 2021

BioPharm - July 2021 - Biopharmaceutical Analysis

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30 BioPharm International eBook July 2021 earity demonstrates this technique as a reliable proof of principle for identifying and quantifying HCPs. Greater sensi- tivity can be achieved using diaPASEF, a data independent approach in which diaPASEF spectra are matched against a spectral library. LOOKING AHEAD As sophisticated analytical technology evolves, the biopharma industry bene- fits from improved speed, sensitivity, and depth of coverage for HCP identification and quantitation, complementing tradi- tional methods such as ELISA. For both upstream discovery and downstream screening, TIMS QTOF-MS can be employed to increase confidence in HCP identif ication and allow laboratories to identify peptides whose abundance would have been too low to acquire MS– MS data. Biopharma labs cannot afford downtime, so the robustness of modern mass spectrometers is another significant advantage. To demonstrate the robust- ness of the TIMS QTOF-MS paired with the latest chromatography tech- nology, researchers analyzed 4300 sam- ples at 100 samples per day, without the need to stop and clean MS optics (10). Short run times, made possible by meth- ods using PASEF acquisition, as well as robust instrument architecture, are mak- ing sensitive, rapid, in-depth techniques for HCP analysis with TIMS a practical method that could drive the field of bio- therapeutics going forward. REFERENCES 1. V.R. Anicetti, et al., J. Immunol. Meth. 91 213–224 (1986). 2. ICH, Q8 (R2) Pharmaceutical Development, Step 4 version (August 2009). 3. A. Siew, "Impurity Testing of Biologic Drug Products," BioPharm International, 31 (2) 14–19 (2018). 4. USP, USP General Chapter <1132>, "Residual Host Cell Protein Measurement in Biopharmaceuticals," USP 39-NF 34 (Rockville, MD, 2016). 5. F. Meier, et al., Mol. Cell. Proteomics 17 (12) 2534–2545 (2018). 6. N. Bache, et al., Mol. Cell. Proteomics 17 (11) 2284–2296 (2018). 7. L. Huang, et al., Anal. Chem. 89 (10) 5436–5444 (2017). 8. Q. Wang, et al., Anal. Chem. 92 (15) 10327–10335 (2020). 9. S. Pengelley, et al., "Enhanced Detection of Host Cell Proteins Enabled by Use of Collisional Cross Sections," poster presentation at ASMS 2020 (online meeting, 2020). 10. R. Fischer, Clinical Proteomics in Interesting Times," Bruker User Meeting at ASMS 2020 (online meeting, 2020) . BP Biopharmaceutical Analysis Impurity Analysis Figure 3. Theoretical vs measured abundance (mean average) of simulated host cell proteins in % of 4 ng UPS2 in 200 ng NISTmAb. - confidential - 0.001 0.01 0.1 1 10 100 0.0001 0.001 0.01 0.1 1 10 100 Measured Abundance Theoretical Abundance

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