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Inhalation OctOber 2024 17 particles and protein aggregates. J Pharm Sci, 2020. 109(1): p. 452-463. 31. Lu, X., et al., Nanoparticle tracking for pro- tein aggregation research. Methods Mol Biol, 2018. 1777: p. 145-158. 32. Wu, D., et al., Standard protocol for mass pho- tometry experiments. Eur Biophys J, 2021. 50(3-4): p. 403-409. 33. Young, G., et al., Quantitative mass imaging of single biological macromolecules. Science, 2018. 360(6387): p. 423-427. 34. Paul, S.S., et al., Quantifying oligomer popula- tions in real time during protein aggregation using single-molecule mass photometry. ACS Nano, 2022. 16(10): p. 16462-16470. 35. Sonn-Segev, A., et al., Quantifying the heteroge- neity of macromolecular machines by mass photom- etry. Nat Commun, 2020. 11(1): p. 1772. 36. Wu, D. et al., Measuring the affinity of protein- protein interactions on a single-molecule level by mass photometry. Anal Biochem, 2020. 592: p. 113575. 37. Wu, D. et al., Rapid determination of antibody- antigen affinity by mass photometry. J Vis Exp, 2021(168). 38. Ignjatovic, J., et al., Aggregation of recombi- nant monoclonal antibodies and its role in poten- tial immunogenicity. Curr Pharm Biotechnol, 2018. 19(4): p. 343-356. Michael Y.T. Chow, PhD, is a postdoctoral research fel- low and Jenny K.W. Lam, PhD, is an associate profes- sor at the UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London, WC1N 1AX, United Kingdom, michael.chow@ucl.ac.uk, jenny.lam@ucl.ac.uk. 17. Sharma, D.K., et al., Micro-flow imaging: Flow microscopy applied to sub-visible particulate analy- sis in protein formulations. AAPS J, 2010. 12(3): p. 455-464. 18. Hufnagel, S., et al., Dry powders for inhalation containing monoclonal antibodies made by thin-film freeze-drying. Int J Pharm, 2022. 618: p. 121637. 19. Raynal, B., et al., Quality assessment and opti- mization of purified protein samples: Why and how? Microb Cell Fact, 2014. 13: p. 180. 20. Pignataro, M.F., et al., Evaluation of peptide/pro- tein self-assembly and aggregation by spectroscopic methods. Molecules, 2020. 25(20): p. 4854. 21. Pan, H.W., et al., Enhanced powder dispersion of dual-excipient spray-dried powder formulations of a monoclonal antibody and its fragment for local treatment of severe asthma. Int J Pharm, 2023. 644: p. 123272. 22. Seow, H.C., et al., Neutralisation of SARS- CoV-2 by monoclonal antibody through dual tar- geting powder formulation. J Control Release, 2023. 358: p. 128-141. 23. Wang, W.H., et al., Specific and high-resolution identification of monoclonal antibody fragments detected by capillary electrophoresis-sodium dodecyl sulfate using reversed-phase HPLC with top-down mass spectrometry analysis. MAbs, 2019. 11(7): p. 1233-1244. 24. Schule, S., et al., Conformational analysis of protein secondary structure during spray-drying of antibody/mannitol formulations. Eur J Pharm Bio- pharm, 2007. 65(1): p. 1-9. 25. Brunaugh, A.D., et al., Identification of stability constraints in the particle engineering of an inhaled monoclonal antibody dried powder. J Pharm Sci, 2022. 111(2): p. 403-416. 26. Respaud, R., et al., Effect of formulation on the stability and aerosol performance of a nebulized anti- body. MAbs, 2014. 6(5): p. 1347-1355. 27. Maa, Y.F., et al., Effect of spray drying and sub- sequent processing conditions on residual moisture content and physical/biochemical stability of pro- tein inhalation powders. Pharm Res, 1998. 15(5): p. 768-775. 28. Arte, K.S., et al., Understanding the impact of mannitol on physical stability and aerosolization of spray-dried protein powders for inhalation. Int J Pharm, 2024. 650: p. 123698. 29. Filipe, V., et al., Critical evaluation of nanopar- ticle tracking analysis (NTA) by NanoSight for the measurement of nanoparticles and protein aggre- gates. Pharm Res, 2010. 27(5): p. 796-810. 30. Hoover, B.M., et al., Evaluation of nanoparti- cle tracking analysis for the detection of rod-shaped