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The Food and Drug Administration (2018) What are “biologics” questions and answers. http://fdagov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers . Accessed 18 Jan 2022
The Food and Drug Administration (2018) Definition of the Term “Biological Product” Docket No FDA-2018-N-2732 https://www.fda.gov/media/122985/download and http://fda.gov/media/108557/download . Accessed 31 Jul 2023
Lill JR (2017) Introduction to biotherapeutics. In: Lill JR, Sandoval W (eds) Analytical characterization of biotherapeutics. Wiley, New York
DOI
Carter PJ (2011) Introduction to current and future protein therapeutics: a protein engineering perspective. Exp Cell Res 317:1261–1269
PubMed
DOI
Lau JL, Dunn MK (2018) Therapeutic peptides: historical perspectives, current development trends, and future directions. Bioorg Med Chem 26:2700–2707
PubMed
DOI
Henricks LM, Schellens JHM, Huitema ADR, Beijnen JH (2015) The use of combinations of monoclonal antibodies in clinical oncology. Cancer Treat Rev 41:859–867
PubMed
DOI
Salfeld JG (2007) Isotype selection in antibody engineering. Nat Biotechnol 25:1369–1372
PubMed
DOI
Thomson CA (2016) IgG structure and function. In: Delves PJ (ed) Encyclopedia of immunobiology, vol 2E. Academic Press, Cambridge
Liu H, Nowak C, Andrien B et al (2017) Impact of IgG Fc-oligosaccharides on recombinant monoclonal antibody structure, stability, safety, and efficacy. Biotechnol Prog 33:1173–1181
PubMed
DOI
Beck A, Sanglier-Cianférani S, van Dorsselaer A (2012) Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry. Anal Chem 84:4637–4646
PubMed
DOI
Barnes CAS, Lim A (2007) Applications of mass spectrometry for the structural characterization of recombinant protein pharmaceuticals. Mass Spectrom Rev 26:370–388
DOI
Srzentić K, Fornelli L, Tsybin YO et al (2020) Interlaboratory study for characterizing monoclonal antibodies by top-down and middle-down mass spectrometry. J Am Soc Mass Spectrom 31(9):1783–1802
PubMed
DOI
PMC
James EI, Murphree TA, Vorauer C et al (2021) Advances in hydrogen/deuterium exchange mass spectrometry and the pursuit of challenging biological systems. Chem Rev 122:7562
PubMed
DOI
PMC
Engen JR, Botzanowski T, Peterle D et al (2021) Developments in hydrogen/deuterium exchange mass spectrometry. Anal Chem 93:567–582
PubMed
DOI
Englander SW, Mayne L, Bai Y, Sosnick TR (1997) Hydrogen exchange: the modern legacy of Linderstrøm-Lang. Protein Sci 6:1101
PubMed
DOI
PMC
Englander SW, Mayne L (1992) Protein folding studied using hydrogen-exchange labeling and two-dimensional NMR. Annu Rev Biophys Biomol Struct 21:243–265
PubMed
DOI
Blakeley MP, Langan P, Niimura N, Podjarny A (2008) Neutron crystallography: opportunities, challenges, and limitations. Curr Opin Struct Biol 18:593
PubMed
DOI
PMC
Zhang Z, Smith DL (1993) Determination of amide hydrogen exchange by mass spectrometry: a new tool for protein structure elucidation. Protein Sci 2:522
PubMed
DOI
PMC
Kan Z-YY, Walters BT, Mayne L, Englander SW (2013) Protein hydrogen exchange at residue resolution by proteolytic fragmentation mass spectrometry analysis. Proc Natl Acad Sci U S A 110:16438–16443
PubMed
DOI
PMC
Englander SW, Kallenbach NR (1983) Hydrogen exchange and structural dynamics of proteins and nucleic acids. Q Rev Biophys 16:521–655
PubMed
DOI
Masson GR, Burke JE, Ahn NG et al (2019) Recommendations for performing, interpreting and reporting hydrogen deuterium exchange mass spectrometry (HDX-MS) experiments. Nat Methods 16(7):595–602
PubMed
DOI
PMC
Rand KD, Zehl M, Jensen ON, Jørgensen TJD (2009) Protein hydrogen exchange measured at single-residue resolution by electron transfer dissociation mass spectrometry. Anal Chem 81:5577–5584
PubMed
DOI
Mistarz UH, Bellina B, Jensen PF et al (2018) UV photodissociation mass spectrometry accurately localize sites of backbone deuteration in peptides. Anal Chem 90:1077–1080
PubMed
DOI
Kadek A, Mrazek H, Halada P et al (2014) Aspartic protease nepenthesin-1 as a tool for digestion in hydrogen/deuterium exchange mass spectrometry. Anal Chem 86:4287–4294
PubMed
DOI
Kadek A, Tretyachenko V, Mrazek H et al (2014) Expression and characterization of plant aspartic protease nepenthesin-1 from Nepenthes gracilis. Protein Expr Purif 95:121–128
PubMed
DOI
Yang M, Hoeppner M, Rey M et al (2015) Recombinant nepenthesin II for hydrogen/deuterium exchange mass spectrometry. Anal Chem 87:6681–6687
PubMed
DOI
Cravello L, Lascoux D, Forest E (2003) Use of different proteases working in acidic conditions to improve sequence coverage and resolution in hydrogen/deuterium exchange of large proteins. Rapid Commun Mass Spectrom 17:2387–2393
PubMed
DOI
Ahn J, Jung MC, Wyndham K et al (2012) Pepsin immobilized on high-strength hybrid particles for continuous flow online digestion at 10,000 psi. Anal Chem 84:7256–7262
PubMed
DOI
PMC
Ständer S, Grauslund LR, Scarselli M et al (2021) Epitope mapping of polyclonal antibodies by hydrogen-deuterium exchange mass spectrometry (HDX-MS). Anal Chem 93:11669–11678
PubMed
DOI
Gramlich M, Hays HCW, Crichton S et al (2021) HDX-MS for epitope characterization of a therapeutic ANTIBODY candidate on the calcium-binding protein annexin-A1. Antibodies 10:11
PubMed
DOI
PMC
Pan J, Zhang S, Chou A, Borchers CH (2016) Higher-order structural interrogation of antibodies using middle-down hydrogen/deuterium exchange mass spectrometry. Chem Sci 7:1480–1486
PubMed
DOI
Jensen PF, Larraillet V, Schlothauer T et al (2015) Investigating the interaction between the neonatal Fc receptor and monoclonal antibody variants by hydrogen/deuterium exchange mass spectrometry. Mol Cell Proteomics 14:148–161
PubMed
DOI
Majumdar R, Manikwar P, Hickey JM et al (2013) Effects of salts from the Hofmeister series on the conformational stability, aggregation propensity, and local flexibility of an IgG1 monoclonal antibody. Biochemistry 52:3376–3389
PubMed
DOI
Hudgens JW, Gallagher ES, Karageorgos I et al (2019) Interlaboratory comparison of hydrogen–deuterium exchange mass spectrometry measurements of the fab fragment of NISTmAb. Anal Chem 91:7336–7345
PubMed
DOI
PMC
Wei H, Mo J, Tao L et al (2014) Hydrogen/deuterium exchange mass spectrometry for probing higher order structure of protein therapeutics: methodology and applications. Drug Discov Today 19:95–102
PubMed
DOI
Pandit D, Tuske SJ, Coales SJ et al (2012) Mapping of discontinuous conformational epitopes by amide hydrogen/deuterium exchange mass spectrometry and computational docking. J Mol Recognit 25:114–124
PubMed
DOI
Rose RJ, van Berkel PHC, van den Bremer ETJ et al (2013) Mutation of Y407 in the CH3 domain dramatically alters glycosylation and structure of human IgG. mAbs 5:219
PubMed
DOI
PMC
Houde D, Peng Y, Berkowitz SA, Engen JR (2010) Post-translational modifications differentially affect IgG1 conformation and receptor binding. Mol Cell Proteomics 9:1716–1728
PubMed
DOI
PMC
Rey M, Man P, Brandolin G et al (2009) Recombinant immobilized rhizopuspepsin as a new tool for protein digestion in hydrogen/deuterium exchange mass spectrometry. Rapid Commun Mass Spectrom 23:3431–3438
PubMed
DOI
Hamuro Y, Zhang T (2018) High-resolution HDX-MS of cytochrome c using pepsin/fungal protease type XIII mixed bed column. J Am Soc Mass Spectrom 30:227–234
PubMed
DOI
Trcka F, Durech M, Man P et al (2014) The assembly and intermolecular properties of the Hsp70-Tomm34-Hsp90 molecular chaperone complex. J Biol Chem 289:9887–9901
PubMed
DOI
PMC
Wales TE, Eggertson MJ, Engen JR (2013) Considerations in the analysis of hydrogen exchange mass spectrometry data. In: Matthiesen R (ed) Mass spectrometry data analysis in proteomics. Humana Press, Totowa
Filandr F, Kavan D, Kracher D et al (2020) Structural dynamics of lytic polysaccharide monooxygenase during catalysis. Biomol Ther 10(2):242
Cline DJ, Redding SE, Brohawn SG et al (2004) New water-soluble phosphines as reductants of peptide and protein disulfide bonds: reactivity and membrane permeability. Biochemistry 43:15195–15203
PubMed
DOI
Trabjerg E, Jakobsen RU, Mysling S et al (2015) Conformational analysis of large and highly disulfide-stabilized proteins by integrating online electrochemical reduction into an optimized H/D exchange mass spectrometry workflow. Anal Chem 87:8880–8888
PubMed
DOI
Comamala G, Krogh CC, Nielsen VS et al (2021) Hydrogen/deuterium exchange mass spectrometry with integrated electrochemical reduction and microchip-enabled deglycosylation for epitope mapping of heavily glycosylated and disulfide-bonded proteins. Anal Chem 93:16330–16340
PubMed
DOI
Majumdar R, Esfandiary R, Bishop SM et al (2015) Correlations between changes in conformational dynamics and physical stability in a mutant IgG1 mAb engineered for extended serum half-life. mAbs 7:84–95
PubMed
DOI
Toth RT, Pace SE, Mills BJ et al (2018) Evaluation of hydrogen exchange mass spectrometry as a stability-indicating method for formulation excipient screening for an IgG4 monoclonal antibody. J Pharm Sci 107:1009–1019
PubMed
DOI
Mullahoo J, Zhang T, Clauser K et al (2020) Dual protease type XIII/pepsin digestion offers superior resolution and overlap for the analysis of histone tails by HX-MS. Methods 184:135–140
PubMed
DOI
PMC
Kuhne F, Bonnington L, Malik S et al (2019) The impact of immunoglobulin G1 Fc sialylation on backbone amide H/D exchange. Antibodies 8:49
PubMed
DOI
PMC
Kadek A, Kavan D, Marcoux J et al (2017) Interdomain electron transfer in cellobiose dehydrogenase is governed by surface electrostatics. Biochim Biophys Acta Gen Subj 1861:157–167
PubMed
DOI
Vankova P, Salido E, Timson DJ et al (2019) A dynamic core in human NQO1 controls the functional and stability effects of ligand binding and their communication across the enzyme dimer. Biomol Ther 9(11):728
Moroco JA, Engen JR (2015) Replication in bioanalytical studies with HDX MS: aim as high as possible. Bioanalysis 7:1065–1067
PubMed
DOI
PMC
Lindner R, Lou X, Reinstein J et al (2014) Hexicon 2: automated processing of hydrogen-deuterium exchange mass spectrometry data with improved deuteration distribution estimation. J Am Soc Mass Spectrom 25:1018–1028
PubMed
DOI
PMC
Raval S, Sarpe V, Hepburn M et al (2021) Improving spectral validation rates in hydrogen-deuterium exchange data analysis. Anal Chem 93:4246–4254
PubMed
DOI
Kan Z-Y, Ye X, Skinner JJ et al (2019) ExMS2: an integrated solution for hydrogen-deuterium exchange mass spectrometry data analysis. Anal Chem 91:7474–7481
PubMed
DOI
Filandrova R, Kavan D, Kadek A et al (2021) Studying protein-DNA interactions by hydrogen/deuterium exchange mass spectrometry. Methods Mol Biol 2247:193–219
PubMed
DOI
Trcka F, Durech M, Vankova P et al (2020) The interaction of the mitochondrial protein importer TOMM34 with HSP70 is regulated by TOMM34 phosphorylation and binding to 14-3-3 adaptors. J Biol Chem 295:8928–8944
PubMed
DOI
PMC
Houde D, Berkowitz SA, Engen JR (2011) The utility of hydrogen/deuterium exchange mass spectrometry in biopharmaceutical comparability studies. J Pharm Sci 100:2071–2086
PubMed
DOI
Mendillo ML, Putnam CD, Mo AO et al (2010) Probing DNA- and ATP-mediated conformational changes in the MutS family of mispair recognition proteins using deuterium exchange mass spectrometry. J Biol Chem 285:13170–13182
PubMed
DOI
PMC
Lau AM, Claesen J, Hansen K, Politis A (2021) Deuteros 2.0: peptide-level significance testing of data from hydrogen deuterium exchange mass spectrometry. Bioinformatics 37:270–272
PubMed
DOI
PMC
Waterhouse A, Bertoni M, Bienert S et al (2018) SWISS-MODEL: homology modelling of protein structures and complexes. Nucleic Acids Res 46:W296–W303
PubMed
DOI
PMC
Webb B, Sali A (2016) Comparative protein structure modeling using MODELLER. Curr Protoc Bioinformatics 54:5.6.1–5.6.37
PubMed
DOI
Rey M, Mrázek H, Pompach P et al (2010) Effective removal of nonionic detergents in protein mass spectrometry, hydrogen/deuterium exchange, and proteomics. Anal Chem 82:5107–5116
PubMed
DOI
Man P, Montagner C, Vitrac H et al (2010) Accessibility changes within diphtheria toxin T domain when in the functional molten globule state, as determined using hydrogen/deuterium exchange measurements. FEBS J 277:653–662
PubMed
DOI
Glasoe PK, Long FA (2002) Use of glass electrodes to measure acidities in deuterium oxide. J Phys Chem 64:188–190
DOI
Calvaresi V, Truelsen LT, Larsen SB et al (2021) Conformational dynamics of free and membrane-bound human Hsp70 in model cytosolic and endo-lysosomal environments. Commun Biol 4:1369
PubMed
DOI
PMC
Guo C, Steinberg LK, Henderson JP, Gross ML (2020) Organic solvents for enhanced proteolysis of stable proteins for hydrogen-deuterium exchange mass spectrometry. Anal Chem 92:11553–11557
PubMed
DOI
PMC
Burns KM, Rey M, Baker CAH, Schriemer DC (2013) Platform dependencies in bottom-up hydrogen/deuterium exchange mass spectrometry. Mol Cell Proteomics 12:539–548
PubMed
DOI
Wollenberg DTW, Wollenberg DTW, Pengelley S et al (2020) Avoiding H/D scrambling with minimal ion transmission loss for HDX-MS/MS-ETD analysis on a high-resolution Q-TOF mass spectrometer. Anal Chem 92:7453–7461
PubMed
DOI
Majumdar R, Manikwar P, Hickey JM et al (2012) Minimizing carry-over in an online pepsin digestion system used for the H/D exchange mass spectrometric analysis of an IgG1 monoclonal antibody. J Am Soc Mass Spectrom 23:2140–2148
PubMed
DOI