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25691715,32882422,29499299,15760738,26048747,32946895,34453927,33319329,17387698,9552449,23353012,22038473,35417176,30999050,27279064,35879500,29030532,17722086,9619788,18477504,28276783,29567196,34474111,23001898,31445157,18248803,30849470,10100310,25714115,30576708,35259440,23933147,25868994,26135384,23596974,25074469,34324986,29740758,26455339,22943172,20491538,17372697,23415813,17286290,15541912,25331092,24468629,17510889,16872767,31536784,29890173,25735896,32590097,26757148,27789805,31200738,12124985,16084699,15176078,34771109,17034996,18782609,25660067,34696356,25814034,15070103,15203931,21129458,22155763,33548460,28163231,29031849,20219608,11170024,31866444,25504535,30070161,23904207,14604464,20951781,28655664,29486303,16338123,23587645,21335078,31077763,18509597,26422647,29649570,33811968,24858396,20659510,22960501,29299701,12532382,15451594,24447788,20519207,28925794,12669973,26970252,17150339,26007290,15661497,25994980,17269918,24668602,17318421,26048746,19059291,26886330,21271316,34203164,14762916,30902103,12226840,29626509,22900470,26872795,29486286,17964129,23500620,24657824,28890220,33037471,24950368,24785575,36181875,10213364,23974958,29627069,34724366,26242787,31622600,30545371,15070104,11767112,34256969,32184179,31035438,18181542,35931906,33862136,33896355,15000469,29348099,35568256,29047017,31054050,29175644,31808069,21535593,30949139,36738804,32376369,30779951,34799334,33227375,35189314,29980982,27761706,36408266,31394183,34058328,30359685,35779665,35257695,30440084,18564902,32318974,30471373,35959704,35890327,11405291,24531119,33484735,34732383,34935582,18197788,29787800,31845128,30717026,32672979,11835198,27918209,31595726,29778825,30244146,30951858,16885131,11469385,35745703,30604256,33011253,34550790,29783783,26797970,30068280,30831193,20464536,30890450,18777240,19442711,32431353,18363140,33233520,30634423,34204083,24040240,24729702,18404252,29713822,16715384,32446961,19883259,32064950,33753213,34452123,32678066,30677417,31678379,30521944,28423954,29545321,36906322,33833502,10518679,24829132,34697726,9811498,23061546,29807525,28551424,28368215,30525659,31376020,33803976,23651398,12880281,31407115,29911689,30773200,31306751,33333176,28668340,34225583,37145380,30682340,36838532,16819209,14744478,7932040,15581077,30910632,11926355,34229002,22129880,32525915,33530610,15587916,35174693,9706052,17851444,25106135,36559140,22791169,35598390,36281398,29564099,37131104,29860975,35577037,35456634,11897427,29935826,29065930,33049261,10738652,26142862,33067839,17121189,24720661,11485186,31917464,26740242,10906726,28986319,33486021,32237417,25618319,36463415,10585234,33188928,30836115,35986124,31276620,29800618,34742827,26633352,25041538,35630671,29981411,34550438,36496560,29954227,35888466,33053425,35764755,29183741,31748057,35314998,33967305,31842296,11195425,35108154,24641877,30484319,33884852,32911043,11165076,37084889,31626961,36781084,27450412,18379901,17879291,30701324,30809740,25529646,29196273,17141436,34467438,36456666,25876914,33316241,24892214,16544906,30381187,24966433,29853610,20706878,33270864,26290202,31882105,31861054,30909381,30174027,26865679,15521329,33025335,28624416,22332943,31172323,34748814,27407206,19418951,22043873,28860086,33540024,7730665,17999163,12741608,31963518,31678249,10716598,34181992,33819784,30786788,32192033,10967438,30604109,34455056,33813721,35534700,26593559,32770018,12523664,33954856,29649124,34471325,14965225,10738650,28923767,33435574,33997988,32104389,29890172,32883387,37051362,29896855,28298682,33238191,33923196,36533138,30218826,23572804,32019061,30236648,31981704,18982512,10231881,28976898,28920341,32006605,31620905,33073379,26981867,30145244,31108730,34337144,235608,27295965,34452239,29182876,34722754,31233863,34931259,34919998,36529257,27600322,1195120,11849908,31027229,30126135,23572728,33781083,30884676,36365172,10587113,37107293,28414191,23794038,27974591,21560023,32070705,28416854,8894088,30065420,28371521,23883920,36770661,31744221,33157211,12436915,33793810,33828923,35282920,33463328,22585372,32961991,12550779,35267360,22755021,21560022,14994793,34294979,33940028,36916127,31367363,26860489,31415872,15129981,29216805,21491268,35083639,30906942,32959262,14503576,35605688,11165077,26446470,36985987,29600616,29913270,31996059,29679468,28758834,32914123,31030909,29892110,23352037,30134183,31539468,29258911,36568503,31614551,16462060,18581212,32455958,12754007,32590123,29733948,16353973,30908633,15926665,33595093,32116375,35059874,30922716,28035628,27134535,33754257,31877805,18338241,34746748,36908341,28583334,34452221,6864497,22845040,33715102,20626334,34951228,31975704,32684786,11147128,31537965,15204638,32076782,30009985,2014208,29441958,30468830,32743712,34560208,7629277,17685277,24236997,31626967,30308177,29775665,11377934,14602195,27194596,36838478,33685709,23351334,32685957,31144213,35004661,34813800,36465512,26946848,37127138,31357899,32123513,10499837,34508271,17101513,12433434,35564075,15635222,24444112,32794710,34547393,30651338,29969710,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Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying-the Road to Manufacturing Scale.

Gikanga B, Turok R, Hui A, Bowen M, Stauch OB, Maa YF. Gikanga B, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):59-73. doi: 10.5731/pdajpst.2015.01003. PDA J Pharm Sci Technol. 2015. PMID: 25691715

Formulating monoclonal antibodies as powders for reconstitution at high concentration using spray-drying: Trehalose/amino acid combinations as reconstitution time reducing and stability improving formulations.

Massant J, Fleurime S, Batens M, Vanhaerents H, Van den Mooter G. Massant J, et al. Eur J Pharm Biopharm. 2020 Nov;156:131-142. doi: 10.1016/j.ejpb.2020.08.019. Epub 2020 Aug 31. Eur J Pharm Biopharm. 2020. PMID: 32882422

Formulating monoclonal antibodies as powders for reconstitution at high concentration using spray drying: Models and pitfalls.

Batens M, Massant J, Teodorescu B, Van den Mooter G. Batens M, et al. Eur J Pharm Biopharm. 2018 Jun;127:407-422. doi: 10.1016/j.ejpb.2018.02.002. Epub 2018 Feb 27. Eur J Pharm Biopharm. 2018. PMID: 29499299

Effects of process variables on the powder yield of spray-dried trehalose on a laboratory spray-dryer.

Maury M, Murphy K, Kumar S, Shi L, Lee G. Maury M, et al. Eur J Pharm Biopharm. 2005 Apr;59(3):565-73. doi: 10.1016/j.ejpb.2004.10.002. Eur J Pharm Biopharm. 2005. PMID: 15760738

Filling of High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes: Investigating Formulation-Nozzle Interactions To Minimize Nozzle Clogging.

Shieu W, Stauch OB, Maa YF. Shieu W, et al. PDA J Pharm Sci Technol. 2015 May-Jun;69(3):417-26. doi: 10.5731/pdajpst.2015.01055. PDA J Pharm Sci Technol. 2015. PMID: 26048747

Comparison of Strategies in Development and Manufacturing of Low Viscosity, Ultra-High Concentration Formulation for IgG1 Antibody.

Deokar V, Sharma A, Mody R, Volety SM. Deokar V, et al. J Pharm Sci. 2020 Dec;109(12):3579-3589. doi: 10.1016/j.xphs.2020.09.014. Epub 2020 Sep 15. J Pharm Sci. 2020. PMID: 32946895 Free PMC article.

Identification of Stability Constraints in the Particle Engineering of an Inhaled Monoclonal Antibody Dried Powder.

Brunaugh AD, Ding L, Wu T, Schneider M, Khalaf R, Smyth HDC. Brunaugh AD, et al. J Pharm Sci. 2022 Feb;111(2):403-416. doi: 10.1016/j.xphs.2021.08.022. Epub 2021 Aug 26. J Pharm Sci. 2022. PMID: 34453927

Peptide Isolation via Spray Drying: Particle Formation, Process Design and Implementation for the Production of Spray Dried Glucagon.

Doerr FJS, Burns LJ, Lee B, Hinds J, Davis-Harrison RL, Frank SA, Florence AJ. Doerr FJS, et al. Pharm Res. 2020 Dec 14;37(12):255. doi: 10.1007/s11095-020-02942-5. Pharm Res. 2020. PMID: 33319329 Free PMC article.

High concentration formulation feasibility of human immunoglubulin G for subcutaneous administration.

Dani B, Platz R, Tzannis ST. Dani B, et al. J Pharm Sci. 2007 Jun;96(6):1504-17. doi: 10.1002/jps.20508. J Pharm Sci. 2007. PMID: 17387698

The effect of operating and formulation variables on the morphology of spray-dried protein particles.

Maa YF, Costantino HR, Nguyen PA, Hsu CC. Maa YF, et al. Pharm Dev Technol. 1997 Aug;2(3):213-23. doi: 10.3109/10837459709031441. Pharm Dev Technol. 1997. PMID: 9552449

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