MAbDelivery: Administration routes for antibody therapy Third LabEx MAbImprove industrial workshop, July 2, 2015 Tours, France

References

• Pèlegrin A, Daguet A, Watier H. MAbImprove: a French “Laboratoire d'excellence” (LabEx) dedicated to therapeutic antibodies. mAbs 2014; 6(4):803-4; PMID:24842678; http://dx.doi.org/10.4161/mabs.29262
   PubMed Web of Science ®Google Scholar
• Guillon-Munos A, Daguet A, Watier H. Antibody biosimilars: fears or opportunities?: First LabEx MAbImprove industrial workshop, May 28, 2013; Tours, France. mAbs 2014; 6(4):805-9; PMID:24714167; http://dx.doi.org/10.4161/mabs.28831
   PubMed Web of Science ®Google Scholar
• MAbDelivery Administration routes for antibody therapy. http://mabdelivery.fr.
   Google Scholar
• Bardin C, Astier A, Vulto A, Sewell G, Vigneron J, Trittler R, Daouphars M, Paul M, Trojniak M, Pinguet F, et al. Guidelines for the practical stability studies of anticancer drugs: a European consensus conference. Ann Pharm Fr 2011; 69(4):221-31; PMID:21840442; http://dx.doi.org/10.1016/j.pharma.2011.07.002
   PubMedGoogle Scholar
• Paul M, Vieillard V, Jaccoulet E, Astier A. Long-term stability of dilutes solutions of the monoclonal antibody rituximab. Int J Pharm 2012; 436(1–2):282-90; PMID:22789912; http://dx.doi.org/10.1016/j.ijpharm.2012.06.063
   PubMed Web of Science ®Google Scholar
• Paul M, Vieillard V, Da Silva Lemos R, Escalup L, Astier A. Long-term physico-chemical stability of diluted trastuzumab. Int J Pharm 2013; 448(1):101-4; PMID:23467078; http://dx.doi.org/10.1016/j.ijpharm.2013.02.039
   PubMed Web of Science ®Google Scholar
• Bardo-Brouard P, Vieillard V, Shekarian T, Marabelle A, Astier A, Paul M. Stability of ipilimumab in its original vial after opening allows its use for at least 4 weeks and facilitates pooling of residues. Eur J Cancer 2016; 58:8-16; PMID:26922168; http://dx.doi.org/10.1016/j.ejca.2016.01.008
   PubMed Web of Science ®Google Scholar
• Vieillard V, Ramssamy A, Rilcy K, Bellanger A, Astier A, Paul M. Pneumatic conveying systems and physical stability of monoclonal antibodies: example of cetuximab. Poster P221, ECCO Congress 2013.
   Google Scholar
• Guilleminault L, Azzopardi N, Arnoult C, Sobilo J, Hervé V, Montharu J, Guillon A, Andres C, Herault O, Le Pape A, et al. Fate of inhaled monoclonal antibodies after the deposition of aerosolized particles in the respiratory system. J Control Release 2014; 196:344-54; PMID:25451545; http://dx.doi.org/10.1016/j.jconrel.2014.10.003
   PubMed Web of Science ®Google Scholar
• Hervé V, Rabbe N, Guilleminault L, Paul F, Schlick L, Azzopardi N, Duruisseau M, Fouquenet D, Montharu J, Redini F, et al. VEGF neutralizing aerosol therapy in primary pulmonary adenocarcinoma with K-ras activating-mutations. MAbs 2014; 6(6):1638-48; PMID:25484066; http://dx.doi.org/10.4161/mabs.34454
   PubMed Web of Science ®Google Scholar
• Herceptin EPAR. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000278/WC500153233.pdf. Accessed December 12, 2016.
   Google Scholar
• Li L, Kumar S, Buck PM, Burns C, Lavoie J, Singh SK, Warne NW, Nichols P, Luksha N, Boardman D. Concentration dependent viscosity of monoclonal antibody solutions: explaining experimental behavior in terms of molecular properties. Pharm Research 2014; 31:3161-78; PMID:24906598; http://dx.doi.org/10.1007/s11095-014-1409-0
   PubMed Web of Science ®Google Scholar
• Connolly B, Petry C, Yadav S, Demeule B, Ciaccio N, Moore JMR, Shire SJ, Gokarn YR. Weak interactions govern the viscosity of concentrated antibody solutions; high-throughput analysis using the diffusion interaction parameter. Biophys J 2012; 103(1):69-78; PMID:22828333; http://dx.doi.org/10.1016/j.bpj.2012.04.047
   PubMed Web of Science ®Google Scholar
• Yadav S, Shire SJ, Kalonia DS. Factors affecting the viscosity in high concentration solutions of different monoclonal antibodies. J Pharm Sci 2010; 99(12):4812-29; PMID:20821382; http://dx.doi.org/10.1002/jps.22190
   PubMed Web of Science ®Google Scholar
• Warne NW. Development of high concentration protein biopharmaceuticals: the use of platform approaches in formulation development. Eur J Pharm Biopharm 2011; 78(2):2018-12; PMID:21406226; http://dx.doi.org/10.1016/j.ejpb.2011.03.004
   Web of Science ®Google Scholar
• Yadav S, Laue TM, Kalonia DS, Singh SN, Shire SJ. The influence of charge distribution on self-association and viscosity behavior of monoclonal antibody solutions. Mol Pharm 2012; 9(4):791-802; PMID:22352470; http://dx.doi.org/10.1021/mp200566k
   PubMed Web of Science ®Google Scholar
• Laue T. Proximity energies: a framework for understanding concentrated solutions. J Mol Recognit 2012; 25(3):165-73; PMID:22407980; http://dx.doi.org/10.1002/jmr.2179
   PubMed Web of Science ®Google Scholar
• Chennamsetty N, Voynov V, Kayser V, Helk B, Trout BL. Design of therapeutic proteins with enhanced stability. PNAS 2009; 106(29):11937-42; PMID:19571001; http://dx.doi.org/10.1073/pnas.0904191106
   PubMed Web of Science ®Google Scholar
• Markovic I. Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: a risk-based perspective. Expert Opin Drug Saf 2007; 6(5):487–91; PMID:17877437; http://dx.doi.org/10.1517/14740338.6.5.487
   Google Scholar
• Van Hoecke K, Catry C, Vanhaecke F. Determination of elemental impurities in leachate solutions from syringes using sector field ICP-mass spectrometry. J Pharm Biomed Anal 2013; 77:139-44; PMID:23411005; http://dx.doi.org/10.1016/j.jpba.2013.01.021
   PubMed Web of Science ®Google Scholar
• Zuccarello DJ, Murphy MP, Meyer RF, Winslow PA. A comprehensive approach for the determination of extractable and leachable metals in pharmaceutical products by inductively-coupled plasma. J Pharm Sci Technol 2009; 63(4):339-52; PMID:20088247
   Google Scholar
• Jenke DR. Extractables and leachables considerations for prefilled syringes. Expert Opin Drug Deliv 2014; 11(10):1591-600; PMID:24955780; http://dx.doi.org/10.1517/17425247.2014.928281
   PubMed Web of Science ®Google Scholar
• Laube BL, Janssens HM, de Jongh FH, Devadason SG, Dhand R, Diot P, Everard ML, Horvath I, Navalesi P, Voshaar T, et al. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J 2011; 37(6):1308-31; PMID:21310878; http://dx.doi.org/10.1183/09031936.00166410
   PubMed Web of Science ®Google Scholar
• Beck-Broichsitter M, Kleimann P, Schmehl T, Betz T, Bakowsky U, Kissel T, Seeger W. Impact of lyoprotectants for the stabilization of biodegradable nanoparticles on the performance of air-jet, ultrasonic, and vibrating-mesh nebulizers. Eur J Pharm Biopharm 2012; 82(2):272-80; PMID:22820646; http://dx.doi.org/10.1016/j.ejpb.2012.07.004
   PubMed Web of Science ®Google Scholar
• Mc Callion ONM, Patel MJ. Viscosity effects on nebulisation of aqueous solutions. Int J Pharm 1996; 130(2):245-9; http://dx.doi.org/10.1016/0378-5173(95)04291-1
   Web of Science ®Google Scholar
• Ghazanfari T, Elhissi AM, Ding Z, Taylor KM. The influence of physicochemical properties on vibrating-mesh nebulization. Int J Pharm 2007; 339(1–2):103-11; PMID:17451896; http://dx.doi.org/10.1016/j.ijpharm.2007.02.035
   PubMed Web of Science ®Google Scholar
• Münster AM, Bendstrup E, Jensen JI, Gram J. Jet and ultrasonic nebulization of single chain urokinase plasminogen activator (scu-PA). J Aerosol Med 2000; 13(4):325-33; PMID:11262439; http://dx.doi.org/10.1089/jam.2000.13.325
   PubMedGoogle Scholar
• Maillet A, Congy-Jolivet N, Le Guellec S, Vecellio L, Hamard S, Courty Y, Courtois A, Gauthier F, Diot P, Thibault G, et al. Aerodynamical, immunological and pharmacological properties of the anticancer antibody cetuximab following nebulization. Pharm Res 2008; 25(6):1318-26; PMID:18030605; http://dx.doi.org/10.1007/s11095-007-9481-3
   PubMed Web of Science ®Google Scholar
• Bakuridze L, Andrieu V, Dupont C, Dubus JC. Does repeated disinfection of the e-Flow rapid nebulizer affect in vitro performance? J Cyst Fibros 2007; 6(4):309-10; PMID:17276148; http://dx.doi.org/10.1016/j.jcf.2006.12.008
   PubMed Web of Science ®Google Scholar
• Rottier BL, van Erp CJ, Sluyter TS, Heijerman HG, Frijlink HW, Boer AH. Changes in performance of the Pari eFlow rapid and Pari LC Plus during 6 months use by CF patients. J Aerosol Med Pulm Drug Deliv 2009; 22(3):263-9; PMID:19466906; http://dx.doi.org/10.1089/jamp.2008.0712
   PubMed Web of Science ®Google Scholar
• Respaud R, Vecellio L, Diot P, Heuzé-Vourc'h N. Nebulization as a delivery method for mAbs in respiratory diseases. Expert Opin Drug Deliv 2015; 12(6):1027-39; PMID:25557066; http://dx.doi.org/10.1517/17425247.2015.999039
   PubMed Web of Science ®Google Scholar
• Respaud R, Marchand D, Parent C, Pelat T, Thullier P, Tournamille JF, Viaud-Massuard MC, Diot P, Si-Tahar M, Vecellio L, et al. Effect of formulation on the stability and aerosol performance of a nebulized antibody. MAbs 2014; 6(5):1347-55; PMID:25517319; http://dx.doi.org/10.4161/mabs.29938
   PubMed Web of Science ®Google Scholar
• Nicoud L, Owczarz M, Arosio P, Morbidelli M. A multiscale view of therapeutic protein aggregation: a colloid science perspective. Biotechnol J 2015; 10(3):367-78; PMID:25772395; http://dx.doi.org/10.1002/biot.201400858
   PubMed Web of Science ®Google Scholar
• Liu J, Nguyen MD, Andya JD, Shire SJ. Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution. J Pharm Sci 2005; 94(9):1928-40; PMID:16052543; http://dx.doi.org/10.1002/jps.20347
   PubMed Web of Science ®Google Scholar
• Nicoud L, Lattuada M, Yates A, Morbidelli M. Impact of aggregate formation on the viscosity of protein solutions. Soft Matter 2015; 11(27):5513-22; PMID:26061258; http://dx.doi.org/10.1039/C5SM00513B
   PubMed Web of Science ®Google Scholar