Controlled release of therapeutic antibody formats

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 88, Issue 2, 2014, Pages 291-309

  Schweizer, Daniel ^a   Serno, Tim ^a   Goepferich, Achim ^b  

^a NOVARTIS PHARMA AG   (Switzerland)

^b UNIVERSITY OF REGENSBURG   (Germany)

Author keywords

Antibody therapy; Biologic; Drug delivery system; Formulation; Local delivery; Ocular antibody delivery; Polymers; Protein; Sustained release; Therapeutic antibodies

Indexed keywords

ANTIBODY; HYBRID PROTEIN; IMMUNOGLOBULIN F(AB) FRAGMENT; IMMUNOGLOBULIN G; POLYMER; SINGLE CHAIN FRAGMENT VARIABLE ANTIBODY;

CONTROLLED DRUG RELEASE; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG MECHANISM; DRUG STABILITY; HUMAN; NONHUMAN; REVIEW; ANIMAL; DRUG ADMINISTRATION ROUTE; PHARMACOKINETICS;

ANIMALS; ANTIBODIES; DRUG ADMINISTRATION ROUTES; DRUG DELIVERY SYSTEMS; HUMANS; PHARMACOKINETICS;

EID: 84908384270     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2014.08.001     Document Type: Review

References (247)

1. B. Pal, and J. Morris Perceived risks of joint infection following intra-articular corticosteroid injections: a survey of rheumatologists Clin. Rheumatol. 18 1999 264 265
2. K.M. Sampat, and S.J. Garg Complications of intravitreal injections Curr. Opin. Ophthal. 21 2010 178 183
3. W.M. Saltzman Antibodies for treating and preventing disease: the potential role of polymeric controlled release Crit. Rev. Ther. Drug Carrier Syst. 10 1993 111 142
4. J.K. Sherwood, L. Zeitlin, K.J. Whaley, R.A. Cone, and W.M. Saltzman Controlled release of antibodies for long-term topical passive immunoprotection of female mice against genital herpes Nat. Biotechnol. 14 1996 468 471
5. R.L. Cleek, K.C. Ting, G. Eskin, and A.G. Mikos Microparticles of poly(dl-lactic-co-glycolic acid)/poly(ethylene glycol) blends for controlled drug delivery J. Control. Rel. 48 1997 259 268
6. J. Mordenti, K. Thomsen, V. Licko, L. Berleau, J.W. Kahn, R.A. Cuthbertson, E.T. Duenas, A.M. Ryan, C. Schofield, T.W. Berger, Y.G. Meng, and J. Cleland Intraocular pharmacokinetics and safety of a humanized monoclonal antibody in rabbits after intravitreal administration of a solution or a PLGA microsphere formulation Toxicol. Sci. 52 1999 101 106
7. N. Butoescu, O. Jordan, and E. Doelker Intra-articular drug delivery systems for the treatment of rheumatic diseases: a review of the factors influencing their performance Eur. J. Pharm. Biopharm. 73 2009 205 218
8. X. Chevalier Intraarticular treatments for osteoarthritis: new perspectives Curr. Drug Targets 11 2010 546 560
9. W.M. Tian, C.L. Zhang, S.P. Hou, X. Yu, F.Z. Cui, Q.Y. Xu, S.L. Sheng, H. Cui, and H.D. Li Hyaluronic acid hydrogel as Nogo-66 receptor antibody delivery system for the repairing of injured rat brain: in vitro J. Control. Rel. 102 2005 13 22
10. M.F. Fransen, T.C. van der Sluis, F. Ossendorp, R. Arens, and C.J. Melief Controlled local delivery of CTLA-4 blocking antibody induces CD8+ T cell dependent tumor eradication and decreases risk of toxic side-effects Clin. Cancer Res. 2013 5381 5389
11. B. Booth, L. Denham, S. Bouhanik, J. Jacob, and J. Hill Sustained-release ophthalmic drug delivery systems for treatment of macular disorders Drugs Aging 24 2007 581 602
12. T. Yasukawa, Y. Tabata, H. Kimura, and Y. Ogura Ocular drug delivery for bioactive proteins Expert Rev. Ophthalmol. 6 2011 657 667
13. A.P. Chapman PEGylated antibodies and antibody fragments for improved therapy: a review Adv. Drug Delivery Rev. 54 2002 531 545
14. F. Wu, and T. Jin Polymer-based sustained-release dosage forms for protein drugs, challenges, and recent advances AAPS PharmSciTech 9 2008 1218 1229
15. C.J. Janeway, P. Travers, M. Walport, and M. Shlomchik The Structure of a Typical Antibody Molecule, Immunobiology: The Immune System in Health and Disease 2001 Garland Science New York
16. M. Raghavan, and P.J. Bjorkman Fc receptors and their interactions with immunoglobulins Annu. Rev. Cell Dev. Biol. 12 1996 181 220
17. P.N. Boyd, A.C. Lines, and A.K. Patel The effect of the removal of sialic acid, galactose and total carbohydrate on the functional activity of Campath-1H Mol. Immunol. 32 1995 1311 1318
18. A. Wright, and S.L. Morrison Effect of glycosylation on antibody function: implications for genetic engineering Trends Biotechnol. 15 1997 26 32
19. A.M. Goetze, Y.D. Liu, Z. Zhang, B. Shah, E. Lee, P.V. Bondarenko, and G.C. Flynn High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans Glycobiology 21 2011 949 959
20. J.N. Arnold, M.R. Wormald, R.B. Sim, P.M. Rudd, and R.A. Dwek The impact of glycosylation on the biological function and structure of human immunoglobulins Annu. Rev. Immunol. 25 2007 21 50
21. P. Umana, J. Jean-Mairet, R. Moudry, H. Amstutz, and J.E. Bailey Engineered glycoforms of an antineuroblastoma IgG1 with optimized antibody-dependent cellular cytotoxic activity Nat. Biotechnol. 17 1999 176 180
22. S. Martin-Moe, T. Osslund, J.Y. Wang, M. Tahir, R. Deshpande, and S. Hershenson The structure of biological therapeutics J. Feroz, S. Hershenson, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals 2010 John Wiley & Sons 3 40
23. P.J. Carter Potent antibody therapeutics by design Nat. Rev. Immunol. 6 2006 343 357
24. J.G. Salfeld Isotype selection in antibody engineering Nat. Biotechnol. 25 2007 1369 1372
25. M.A. Alyanakian, E. Bernatowska, J.M. Scherrmann, P. Aucouturier, and J.L. Poplavsky Pharmacokinetics of total immunoglobulin G and immunoglobulin G subclasses in patients undergoing replacement therapy for primary immunodeficiency syndromes Vox Sang. 84 2003 188 192
26. T. Yokota, D.E. Milenic, M. Whitlow, and J. Schlom Rapid tumor penetration of a single-chain Fv and comparison with other immunoglobulin forms Cancer Res. 52 1992 3402 3408
27. Y. Guo-Luang, and N. Jian Antibody for human diseases C.G. Shayne, Development of Therapeutic Agents Handbook 2012 John Wiley & Sons
28. R.V.J. Chari Targeted cancer therapy: conferring specificity to cytotoxic drugs Acc. Chem. Res. 41 2007 98 107
29. J.R. Junutula, H. Raab, S. Clark, S. Bhakta, D.D. Leipold, S. Weir, Y. Chen, M. Simpson, S.P. Tsai, M.S. Dennis, Y. Lu, Y.G. Meng, C. Ng, J. Yang, C.C. Lee, E. Duenas, J. Gorrell, V. Katta, A. Kim, K. McDorman, K. Flagella, R. Venook, S. Ross, S.D. Spencer, W. Lee Wong, H.B. Lowman, R. Vandlen, M.X. Sliwkowski, R.H. Scheller, P. Polakis, and W. Mallet Site-specific conjugation of a cytotoxic drug to an antibody improves the therapeutic index Nat. Biotechnol. 26 2008 925 932
30. A.L. Nelson Antibody fragments: hope and hype mAbs 2 2010 77 83
31. D. Schrama, R.A. Reisfeld, and J.C. Becker Antibody targeted drugs as cancer therapeutics Nat Rev. Drug. Discov. 5 2006 147 159
32. C. Huang Receptor-Fc fusion therapeutics, traps, and MIMETIBODY technology Curr. Opin. Biotechnol. 20 2009 692 699
33. G. Hassanzadeh-Ghassabeh, N. Devoogdt, P. De Pauw, C. Vincke, and S. Muyldermans Nanobodies and their potential applications Nanomedicine 8 2013 1013 1026
34. F. Van Bockstaele, J.B. Holz, and H. Revets The development of nanobodies for therapeutic applications Curr. Opin. Invest. Drugs 10 2009 1212 1224
35. G.L. Moore, C. Bautista, E. Pong, D.H. Nguyen, J. Jacinto, A. Eivazi, U.S. Muchhal, S. Karki, S.Y. Chu, and G.A. Lazar A novel bispecific antibody format enables simultaneous bivalent and monovalent co-engagement of distinct target antigens mAbs 3 2011 546 557
36. R.J. Harris Heterogeneity of recombinant antibodies: linking structure to function Dev. Biol. (Basel, Switz.) 122 2005 117 127
37. E.M. Topp, L. Zhang, H. Zhao, R.W. Payne, G.J. Evans, and M.C. Manning Chemical Instability in Peptide and Protein Pharmaceuticals, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals 2010 John Wiley & Sons Inc. pp. 41-67
38. W. Wang, S. Singh, D.L. Zeng, K. King, and S. Nema Antibody structure, instability, and formulation J. Pharm. Sci. 96 2007 1 26
39. D. Kroon, A. Baldwin-Ferro, and P. Lalan Identification of sites of degradation in a therapeutic monoclonal antibody by peptide mapping Pharm. Res. 9 1992 1386 1393
40. T. Igawa, H. Tsunoda, T. Kuramochi, Z. Sampei, S. Ishii, and K. Hattori Engineering the variable region of therapeutic IgG antibodies mAbs 3 2011 243 252
41. J.L. Cleland, M.F. Powell, and S.J. Shire The development of stable protein formulations - a close look at protein aggregation, deamidation, and oxidation Crit. Rev. Ther. Drug Carrier Syst. 10 1993 307 377
42. E.Y. Chi, S. Krishnan, T.W. Randolph, and J.F. Carpenter Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation Pharm. Res. 20 2003 1325 1336
43. R. Krishnamurthy, and M.C. Manning The stability factor: importance in formulation development Curr. Pharm. Biotechnol. 3 2002 361 371
44. W. Wang, S. Nema, and D. Teagarden Protein aggregation - pathways and influencing factors Int. J. Pharm. 390 2010 89 99
45. S.J. Shire, Z. Shahrokh, and J. Liu Challenges in the development of high protein concentration formulations J. Pharm. Sci. 93 2004 1390 1402
46. E. Koren, L.A. Zuckerman, and A.R. Mire-Sluis Immune responses to therapeutic proteins in humans-clinical significance, assessment and prediction Curr. Pharm. Biotechnol. 3 2002 349 360
47. A.S. Rosenberg Effects of protein aggregates: an immunologic perspective AAPS J. 8 2006 E501 E507
48. H. Schellekens Factors influencing the immunogenicity of therapeutic proteins Nephrol. Dial. Transplant. 20 2005 vi3 vi9
49. H.C. Mahler, R. Mueller, W. Friess, A. Delille, and S. Matheus Induction and analysis of aggregates in a liquid IgG1-antibody formulation Eur. J. Pharm. Biopharm. 59 2005 407 417
50. S. Frokjaer, and D.E. Otzen Protein drug stability: a formulation challenge Nat. Rev. Drug Discovery 4 2005 298 306
51. S.Y. Patro, and T.M. Przybycien Simulations of reversible protein aggregate and crystal structure Biophys. J. 70 1996 2888 2902
52. B. Yeung, and B.S. Chang Physical stability of protein pharmaceutical J. Feroz, S. Hershenson, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals 2010 John Wiley & Sons 3 40
53. S.Y. Patro, and T.M. Przybycien Simulations of kinetically irreversible protein aggregate structure Biophys. J. 66 1994 1274 1289
54. H.C. Mahler, W. Friess, U. Grauschopf, and S. Kiese Protein aggregation: pathways, induction factors and analysis J. Pharm. Sci. 98 2009 2909 2934
55. S.N. Timasheff The control of protein stability and association by weak interactions with water: how do solvents affect these processes? Annu. Rev. Biophys. Biomol. Struct. 22 1993 67 97
56. W. Wang Instability, stabilization, and formulation of liquid protein pharmaceuticals Int. J. Pharm. 185 1999 129 188
57. T.J. Kamerzell, R. Esfandiary, S.B. Joshi, C.R. Middaugh, and D.B. Volkin Protein-excipient interactions: mechanisms and biophysical characterization applied to protein formulation development Adv. Drug Delivery Rev. 63 2011 1118 1159
58. L.K. Roskos, C.G. Davis, and G.M. Schwab The clinical pharmacology of therapeutic monoclonal antibodies Drug Dev. Res. 61 2004 108 120
59. L.A. Gatlin, and C.A.B. Gatlin Formulation and administration techniques to minimize injection pain and tissue damage associated with parenteral products P.K. Gapka, G.A. Brazeau, Injectable Drug Development: Techniques to Reduce Pain and Irritation 1999 Interpharm Press Denver 401 425
60. R.J. Harris, S.J. Shire, and C. Winter Commercial manufacturing scale formulation and analytical characterization of therapeutic recombinant antibodies Drug Dev. Res. 61 2004 137 154
61. S.J. Shire, J. Liu, S. Joerg, and H.C. Mahler High-concentration antibody formulations F. Jameel, S. Hershenson, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals 2010 John Wiley & Sons Inc. Hoboken, New Jersey 349 381
62. S.B. Zimmerman, and A.P. Minton Macromolecular crowding: biochemical, biophysical, and physiological consequences Annu. Rev. Biophys. Biomol. Struct. 22 1993 27 65
63. J. Liu, M.D.H. Nguyen, J.D. Andya, and S.J. Shire Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution J. Pharm. Sci. 94 2005 1928 1940
64. S. Yadav, J. Liu, S.J. Shire, and D.S. Kalonia Specific interactions in high concentration antibody solutions resulting in high viscosity J. Pharm. Sci. 99 2010 1152 1168
65. J. Jezek, M. Rides, B. Derham, J. Moore, E. Cerasoli, R. Simler, and B. Perez-Ramirez Viscosity of concentrated therapeutic protein compositions Adv. Drug Delivery Rev. 63 2011 1107 1117
66. W. Du, and A.M. Klibanov Hydrophobic salts markedly diminish viscosity of concentrated protein solutions Biotechnol. Bioeng. 108 2011 632 636
67. M. Bowen, N. Armstrong, and Y.f. Maa Investigating high-concentration monoclonal antibody powder suspension in nonaqueous suspension vehicles for subcutaneous injection J. Pharm. Sci. 101 2012 4433 4443
68. S. Matheus, W. Friess, D. Schwartz, and H.C. Mahler Liquid high concentration IgG1 antibody formulations by precipitation J. Pharm. Sci. 98 2009 3043 3057
69. M.X. Yang, B. Shenoy, M. Disttler, R. Patel, M. McGrath, S. Pechenov, and A.L. Margolin Crystalline monoclonal antibodies for subcutaneous delivery Proc. Natl. Acad. Sci. U. S. A. 100 2003 6934 6939
70. G.I. Frost Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration Expert Opin. Drug Delivery 4 2007 427 440
71. O.H. Brekke, and I. Sandlie Therapeutic antibodies for human diseases at the dawn of the twenty-first century Nat. Rev. Drug Discovery 2 2003 52 62
72. E.D. Lobo, R.J. Hansen, and J.P. Balthasar Antibody pharmacokinetics and pharmacodynamics J. Pharm. Sci. 93 2004 2645 2668
73. S. Lien, and H.B. Lowman Therapeutic anti-VEGF antibodies Y. Chernajovsky, A. Nissim, Therapeutic Antibodies: Handbook of Experimental Pharmacology 2008 Springer-Verlag Berlin Heidelberg
74. D.W. MacGlashan, B.S. Bochner, D.C. Adelman, P.M. Jardieu, A. Togias, J. McKenzie-White, S.A. Sterbinsky, R.G. Hamilton, and L.M. Lichtenstein Down-regulation of Fc(epsilon)RI expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody J. Immunol. 158 1997 1438 1445
75. D.L. Ludwig, D.S. Pereira, Z. Zhu, D.J. Hicklin, and P. Bohlen Monoclonal antibody therapeutics and apoptosis Oncogene 22 2003 9097 9106
76. D.G. Maloney, B. Smith, and A. Rose Rituximab: mechanism of action and resistance Semin. Oncol. 29 2002 2 9
77. M. Tokunaga, K. Fujii, K. Saito, S. Nakayamada, S. Tsujimura, M. Nawata, and Y. Tanaka Down-regulation of CD40 and CD80 on B cells in patients with life-threatening systemic lupus erythematosus after successful treatment with rituximab Rheumatology 44 2005 176 182
78. O. Nieri, D. Donadio, S. Rossi, B. Adinolfi, and N.A. Podesta Antibodies for therapeutic uses and the evolution of biotechniques Curr. Med. Chem. 16 2009 753 779
79. G. Casi, and D. Neri Antibody-drug conjugates: basic concepts, examples and future perspectives J. Control. Rel. 161 2012 422 428
80. L. Kagan, P. Gershkovich, A. Mendelman, S. Amsili, N. Ezov, and A. Hoffman The role of the lymphatic system in subcutaneous absorption of macromolecules in the rat model Eur. J. Pharm. Biopharm. 67 2007 759 765
81. A. Supersaxo, W. Hein, and H. Steffen Effect of molecular weight on the lymphatic absorption of water-soluble compounds following subcutaneous administration Pharm. Res. 7 1990 167 169
82. Y. Vugmeyster, X. Xu, F. Theil, L.A. Khawli, and M.W. Leach Pharmacokinetics and toxicology of therapeutic proteins: advances and challenges World J. Biol. Chem. 26 2012 73 92
83. H. Mach, S.M. Gregory, A. Mackiewicz, S. Mittal, A. Lalloo, M. Kirchmeier, and M. Shameem Electrostatic interactions of monoclonal antibodies with subcutaneous tissue Ther. Delivery 2 2011 727 736
84. A. Baumann Early development of therapeutic biologics - pharmacokinetics Curr. Drug Metab. 7 2006 15 21
85. W. Wang, E.Q. Wang, and J.P. Balthasar Monoclonal antibody pharmacokinetics and pharmacodynamics Clin. Pharmacol. Ther. 84 2008 548 558
86. W. Bauer, C.L. Short, and G.A. Bennett The manner of removal of proteins from normal joints J. Exp. Med. 57 1933 419 433
87. J.R. Levick A method for estimating macromolecular reflection by human synovium, using measurements of intra-articular half lives Ann. Rheum. Dis. 57 1998 339 344
88. R. Keizer, A. Huitema, J. Schellens, and J. Beijnen Clinical pharmacokinetics of therapeutic monoclonal antibodies Clin. Pharmacokinet. 49 2010 493 507
89. T.A. Waldmann, and W. Strober Metabolism of immunoglobulins Prog Allergy 13 1969 1 110
90. E. Israel, D.F. Wilsker, K.C. Hayes, D. Schoenfeld, and N.E. Simister Increased clearance of IgG in mice that lack microglobulin: possible protective role of FcRn Immunology 89 1996 573 578
91. R.P. Junghans, and C.L. Anderson The protection receptor for IgG catabolism is the beta2-microglobulin-containing neonatal intestinal transport receptor Proc. Natl. Acad. Sci. U. S. A. 93 1996 5512 5516
92. X. Zhu, G. Meng, B.L. Dickinson, X. Li, E. Mizoguchi, L. Miao, Y. Wang, C. Robert, B. Wu, P.D. Smith, W.I. Lencer, and R.S. Blumberg MHC class I-related neonatal Fc receptor for IgG is functionally expressed in monocytes, intestinal macrophages, and dendritic cells J. Immunol. 166 2001 3266 3276
93. F. Brambell, W. Hemmings, and I. Morris A theoretical model of gammaglobulin catabolism Nature 203 1964 1352 1354
94. F. Brambell The transmission of immunity from mother to young and the catabolism of immunoglobulins The Lancet 288 1966 1087 1093
95. R.J. Flanagan, and A.L. Jones Fab antibody fragments: some applications in clinical toxicology (Abstract) Drug Saf. 27 2004 1115 1133
96. A. Garg, Investigation of the role of FcRn in the absorption, distribution, and elimination of monoclonal antibodies, 2007, pp. 228-229.
97. M. Farvardin, M. Afarid, and S. Shahrzad Long-term effects of intravitreal infliximab for treatment of sight-threatening chronic noninfectious uveitis J. Ocul. Pharmacol. Ther. 28 2012 628 631
98. P. Lichtlen, T.T. Lam, T.M. Nork, T. Streit, and D.M. Urech Relative contribution of VEGF and TNF-alpha in the cynomolgus laser-induced CNV model: comparing the efficacy of bevacizumab, adalimumab, and ESBA105 Invest. Ophthalmol. Visual Sci. 51 2010 4738 4745
99. M. Ottiger, M.A. Thiel, U. Feige, P. Lichtlen, and D.M. Urech Efficient intraocular penetration of topical anti-TNF-alpha single-chain antibody (ESBA105) to anterior and posterior segment without penetration enhancer Invest. Ophthalmol. Visual Sci. 50 2009 779 786
100. E.B. Rodrigues, M.E. Farah, M.c. Maia, F.M. Penha, C. Regatieri, G.B. Melo, M.M. Pinheiro, and C.R. Zanetti Therapeutic monoclonal antibodies in ophthalmology Prog. Retinal Eye Res. 28 2009 117 144
101. D.M. Brown, P.K. Kaiser, M. Michels, G. Soubrane, J.S. Heier, R.Y. Kim, J.P. Sy, and S. Schneider Ranibizumab versus verteporfin for neovascular age-related macular degeneration N. Engl. J. Med. 355 2006 1432 1444
102. P.J. Rosenfeld, D.M. Brown, J.S. Heier, D.S. Boyer, P.K. Kaiser, C.Y. Chung, and R.Y. Kim Ranibizumab for neovascular age-related macular degeneration N. Engl. J. Med. 355 2006 1419 1431
103. R. Gaudana, H. Ananthula, A. Parenky, and A. Mitra Ocular drug delivery AAPS J. 12 2010 348 360
104. J. Cunha-Vaz The blood-ocular barriers Surv. Ophthalmol. 23 1979 279 296
105. L. Pitkäñnen, V.P. Ranta, H. Moilanen, and A. Urtti Permeability of retinal pigment epithelium: effects of permeant molecular weight and lipophilicity Invest. Ophthalmol. Visual Sci. 46 2005 641 646
106. T.U. Krohne, N. Eter, F.G. Holz, and C.H. Meyer Intraocular pharmacokinetics of bevacizumab after a single intravitreal injection in humans (Abstract) Am. J. Ophthalmol. 146 2008 508 512
107. T.U. Krohne, Z. Liu, F.G. Holz, and C.H. Meyer Intraocular pharmacokinetics of ranibizumab following a single intravitreal injection in humans Am. J. Ophthalmol. 154 2012 682 686
108. M. Kakinoki, T. Miyake, O. Sawada, T. Sawada, H. Kawamura, and M. Ohji, The Clearance of Intravitreal Bevacizumab in Vitrectomized Macaque Eyes (Abstract), Annual meeting of the Association for Research in Vision and Ophthalmology, 2011.
109. T. Yasukawa, Y. Ogura, E. Sakurai, Y. Tabata, and H. Kimura Intraocular sustained drug delivery using implantable polymeric devices Adv. Drug Del. Rev. 57 2005 2033 2046
110. J.B. Ciolino, T.R. Hoare, N.G. Iwata, I. Behlau, C.H. Dohlman, R. Langer, and D.S. Kohane A drug-eluting contact lens Invest. Ophthalmol. Visual Sci. 50 2009 3346 3352
111. M. Zignani, C. Tabatabay, and R. Gurny Topical semi-solid drug delivery: kinetics and tolerance of ophthalmic hydrogels Adv. Drug Del. Rev. 16 1995 51 60
112. G.P. Mishra, M. Bagui, V. Tamboli, and A.K. Mitra Recent applications of liposomes in ophthalmic drug delivery J. Drug Del. 2011
113. A. Zimmer, and J. Kreuter Microspheres and nanoparticles used in ocular delivery systems Adv. Drug Del. Rev. 16 1995 61 73
114. R.C. Nagarwal, S. Kant, P.N. Singh, P. Maiti, and J.K. Pandit Polymeric nanoparticulate system: a potential approach for ocular drug delivery J. Control. Rel. 136 2009 2 13
115. F. Li, B. Hurley, Y. Liu, B. Leonard, and M. Griffith Controlled release of bevacizumab through nanospheres for extended treatment of age-related macular degeneration Open Ophthalmol J. 6 2012 54 58
116. C.K. Pan, C. Durairaj, U.B. Kompella, O. Agwu, S.C.N. Oliver, H. Quiroz-Mercado, N. Mandava, and J.L. Olson Comparison of long-acting bevacizumab formulations in the treatment of choroidal neovascularization in a rat model J. Ocul. Pharmacol. Ther. 27 2011 219 224
117. J.S. Andrew, E.J. Anglin, F. Cunin, C. Tourne-Peteilh, L.C. Cheng, W.R. Freemann, J.M. Devoisselle, and M.J. Sailer Sustained release of a monoclonal antibody from electrochemically prepared porous silica for the treatment of age related macular degeneration (Abstract) Invest. Ophthalmol. Visual Sci. 50 2009
118. L. Cheng, E. Anglin, F. Cunin, D. Kim, M.J. Sailor, I. Falkenstein, A. Tammewar, and W.R. Freeman Intravitreal properties of porous silicon photonic crystals: a potential self-reporting intraocular drug-delivery vehicle Br. J. Ophthalmol. 92 2008 705 711
119. J.S. Andrew, E.J. Anglin, E.C. Wu, M.Y. Chen, L. Cheng, W.R. Freeman, and M.J. Sailor Sustained release of a monoclonal antibody from electrochemically prepared mesoporous silicon oxide Adv. Funct. Mater. 20 2010 4168 4174
120. J.J. Kang Derwent, and W.F. Mieler Thermoresponsive hydrogels as a new ocular drug delivery platform to the posterior segment of the eye Trans. Am. Ophthalmol. Soc. 106 2008 204 206
121. M. Abrishami, S.Z. Ganavati, D. Soroush, M. Rouhbakhsh, M.R. Jaafari, and B. Malaekeh-Nikouei Preparation, characterization, and in vivo evaluation of nanoliposomes-encapsulated bevacizumab (avastin) for intravitreal administration Retina 29 2009 699 703
122. L. Zeitlin, R.A. Conc, and K.J. Whaley Using monoclonal antibodies to prevent mucosal transmission of epidemic infectious diseases Emerging Infect. Dis. 5 1999 54 64
123. Y. Abiko Passive immunization against dental caries and periodontal disease: development of recombinant and human monoclonal antibodies Crit. Rev. Oral Biol. Med. 11 2000 140 158
124. G.S. Ashcroft, M.J. Jeong, J.J. Ashworth, M. Hardman, W. Jin, N. Moutsopoulos, T. Wild, N. McCartney-Francis, D. Sim, G. McGrady, X.y. Song, and S.M. Wahl Tumor necrosis factor-alpha is a therapeutic target for impaired cutaneous wound healing Wound Repair Regen 20 2012 38 49
125. M. Streit, Z. Beleznay, and L.R. Braathen Topical application of the tumour necrosis factor-alpha antibody infliximab improves healing of chronic wounds Int. Wound J. 3 2006 171 179
126. L.T. Sun, S.A. Bencherif, T.W. Gilbert, A.M. Farkas, M.T. Lotze, and N.R. Washburn Biological activities of cytokine-neutralizing hyaluronic acid-antibody conjugates Wound Repair Regen 18 2010 302 310
127. L.T. Sun, E. Friedrich, J.L. Heuslein, R.E. Pferdehirt, N.M. Dangelo, S. Natesan, R.J. Christy, and N.R. Washburn Reduction of burn progression with topical delivery of (antitumor necrosis factor-alpha)-hyaluronic acid conjugates Wound Repair Regen 20 2012 563 572
128. G.L. Brown, L.J. Curtsinger, M. White, R.O. Mtichell, J. Pietsch, R. Nordquist, A.V. Fraunhofer, and G.S. Schultz Acceleration of tensile strength of incisions treated with EGF and TGF-[beta] Ann. Surg. 208 1988 788 794
129. E. Memisoglu, F. Oener, H.S. Kas, L. Zarif, A. Ayhan, I. Basaran, and A.A. Hincal Epidermal growth factor (EGF) wound healing in fluorocarbon and chitosan gels in a rabbit model A.A. Hincal, H.S. Kas, Biomedical Science and Technology 1998 Springer US 155 161
130. R. Schmidt, Topical delivery of a alpha 1-Antichymotrypsin for wound healing, 2005.
131. Y. Tabata, S. Hijikata, and Y. Ikada Enhanced vascularization and tissue granulation by basic fibroblast growth factor impregnated in gelatin hydrogels J. Control. Rel. 31 1994 189 199
132. M.L. Radomsky, K.J. Whaley, R.A. Cone, and W.M. Saltzman Controlled vaginal delivery of antibodies in the mouse Biol. Reprod. 47 1992 133 140
133. J.K. Sherwood, R.B. Dause, and W.M. Saltzman Controlled antibody delivery systems Biotechnology (N Y) 10 1992 1446 1449
134. P.Y. Kuo, J.K. Sherwood, and W.M. Saltzman Topical antibody delivery systems produce sustained levels in mucosal tissue and blood Nat. Biotechnol. 16 1998 163 167
135. M. Bouysset, F. Coury, T. Tavernier, M. Bonnin, J. Damiano, C. Nemoz, and J.G. Tebib Intraarticular injection of adalimumab in localized psoriatic arthritis Med. Chir. Pied. 25 2009 133 135
136. S.N. Nikas, T.I. Temekonidis, A.K. Zikou, M.I. Argyropoulou, S. Efremidis, and A.A. Drosos Treatment of resistant rheumatoid arthritis by intra-articular infliximab injections: a pilot study Ann. Rheum. Dis. 63 2004 102 103
137. L. Schatteman, L. Gyselbrecht, L. De Clercq, and H. Mielants Treatment of refractory inflammatory monoarthritis in ankylosing spondylitis by intraarticular injection of infliximab J. Rheumatol. 33 2006 82 85
138. A.P. Malaviya, and A.J.K. Oestoer Rheumatoid arthritis and the era of biologic therapy Inflammopharmacology 20 2012 59 69
139. N. Gerwin, C. Hops, and A. Lucke Intraarticular drug delivery in osteoarthritis Adv. Drug Del. Rev. 58 2006 226 242
140. J.R. Levick, and J.N. McDonald Fluid movement across synovium in healthy joints: role of synovial fluid macromolecules Ann. Rheum. Dis. 54 1995 417 423
141. S.G. Owen, H.W. Frances, and M.S. Roberts Disappearance kinetics of solutes from synovial fluid after intra-articular injection Br. J. Clin. Pharmacol. 38 1994 349 355
142. P.A. Simkin Fluid dynamics of the joint space and trafficking of matrix products M.J. Seibel, S.P. Robins, J.P. Bilezikian, Dynamics of Bone and Cartilage Metabolism: Principles and Clinical Applications 2006 Elsevier Inc. 451 456
143. C. Larsen, J. Ostergaard, S.W. Larsen, H. Jensen, S. Jacobsen, C. Lindegaard, and P.H. Andersen Intra-articular depot formulation principles: role in the management of postoperative pain and arthritic disorders J. Pharm. Sci. 97 2008 4622 4654
144. S. Abramson Drug delivery in degenerative joint disease: where we are and where to go? Adv. Drug Del. Rev. 58 2006 125 127
145. A. Inoue, K.A. Takahashi, Y. Arai, H. Tonomura, K. Sakao, M. Saito, M. Fujioka, H. Fujiwara, Y. Tabata, and T. Kubo The therapeutic effects of basic fibroblast growth factor contained in gelatin hydrogel microspheres on experimental osteoarthritis in the rabbit knee Arthritis Rheum. 54 2006 264 270
146. X. Li, G. Su, J. Wang, Z. Zhou, L. Li, L. Liu, M. Guan, Q. Zhang, and H. Wang Exogenous bFGF promotes articular cartilage repair via up-regulation of multiple growth factors Osteoarthr. Cartil./OARS, Osteoarthr. Res. Soc. 21 10 2013 1567 1575 1-10-2013
147. S.B. Trippel Growth factor actions on articular cartilage J. Rheumatol. Suppl. 43 1995 129 132
148. R.E. Whitmire, D. Scott Wilson, A. Singh, M.E. Levenston, N. Murthy, and A.J. Garcia Self-assembling nanoparticles for intra-articular delivery of anti-inflammatory proteins Biomaterials 33 2012 7665 7675
149. M.F. Shamji, H. Betre, V.B. Kraus, J. Chen, A. Chilkoti, R. Pichika, K. Masuda, and L.A. Setton Development and characterization of a fusion protein between thermally responsive elastin-like polypeptide and interleukin-1 receptor antagonist: Sustained release of a local antiinflammatory therapeutic Arthritis Rheum. 56 2007 3650 3661
150. A.R. Poole, M. Kobayashi, T. Yasuda, S. Laverty, F. Mwale, T. Kojima, T. Sakai, C. Wahl, S. El-Maadawy, G. Webb, E. Tchetina, and W. Wu Type II collagen degradation and its regulation in articular cartilage in osteoarthritis Ann. Rheum. Dis. 61 2002 ii78 ii81
151. H. Betre, W. Liu, M.R. Zalutsky, A. Chilkoti, V.B. Kraus, and L.A. Setton A thermally responsive biopolymer for intra-articular drug delivery J. Control. Rel. 115 2006 175 182
152. S.B. Adams, M.F. Shamji, D.L. Nettles, S.M. Paranjape, C.H. Evens, E. Gouze, and L.A. Setton A thermally responsive fusion protein of interleukin-1 receptor antagonist attenuates the pathologic response of knee joint cartilage to interleukin-1 in an in vivo model Trans. Orthoped. Res. Soc. 2008
153. K.D. Allen, S.B. Adams, and L.A. Setton Evaluating intra-articular drug delivery for the treatment of osteoarthritis in a rat model Tissue Eng. Part B 16 2010 81 92
154. D. Stepensky Local versus systemic anti-tumour necrosis factor-alpha effects of adalimumab in rheumatoid arthritis Clin. Pharmacokinet. 51 2012 443 455
155. B.S. Bregman, E. Kunkel-Bagden, L. Schnell, H.N. Dai, D. Gao, and M.E. Schwab Recovery from spinal cord injury mediated by antibodies to neurite growth inhibitors Nature 378 1995 498 501
156. S.A. Tan, and P. Aebischer The problems of delivering neuroactive molecules to the CNS Ciba Found. Symp. 1996 211 236
157. A. Misra, S. Ganesh, and A. Shahiwala Drug delivery to the central nervous system: a review J. Pharm. Pharmaceut. Sci. 2003
158. M.D. Baumann, C.E. Kang, J.C. Stanwick, Y. Wang, H. Kim, Y. Lapitsky, and M.S. Shoichet An injectable drug delivery platform for sustained combination therapy J. Control. Rel. 138 2009 205 213
159. K. Fouad, V. Dietz, and M.E. Schwab Improving axonal growth and functional recovery after experimental spinal cord injury by neutralizing myelin associated inhibitors Brain Res. Rev. 36 2001 204 212
160. L.L. Jones, and M.H. Tuszynski Chronic intrathecal infusions after spinal cord injury cause scarring and compression Microsc. Res. Tech. 54 2001 317 324
161. J.R.E. Fraser, T.C. Laurent, and U.B.G. Laurent Hyaluronan: its nature, distribution, functions and turnover J. Intern. Med. 242 1997 27 33
162. M.M. Pakulska, B.G. Ballios, and M.S. Shoichet Injectable hydrogels for central nervous system therapy Biomed. Mater. 7 2012 024101
163. Y.T. Wei, Y. He, C.L. Xu, Y. Wang, B.F. Liu, X.M. Wang, X.D. Sun, F.Z. Cui, and Q.Y. Xu Hyaluronic acid hydrogel modified with nogo-66 receptor antibody and poly-L-lysine to promote axon regrowth after spinal cord injury J. Biomed. Mater. Res. B Appl. Biomater. 95B 2010 110 117
164. J.C. Stanwick, M.D. Baumann, and M.S. Shoichet In vitro sustained release of bioactive anti-NogoA, a molecule in clinical development for treatment of spinal cord injury Int. J. Pharm. 426 2012 284 290
165. M.D. Baumann, C.E. Kang, C.H. Tator, and M.S. Shoichet Intrathecal delivery of a polymeric nanocomposite hydrogel after spinal cord injury Biomaterials 31 2010 7631 7639
166. R.M. Reilly, R.l. Domingo, and J. Sandhu Oral delivery of antibodies Clin. Pharmacokinet. 32 1997 313 323
167. J. Hamman, G. Enslin, and A. Kotze Oral delivery of peptide drugs BioDrugs 19 2005 165 177
168. G.A. Losonsky, J.P. Johnson, J.A. Winkelstein, and R.H. Yolken Oral administration of human serum immunoglobulin in immunodeficient patients with viral gastroenteritis: a pharmacokinetic and functional analysis J. Clin. Invest. 76 1985 2362 2367
169. H. Ochi, M. Abraham, H. Ishikawa, D. Frenkel, K. Yang, A.S. Basso, H. Wu, M.L. Chen, R. Gandhi, A. Miller, R. Maron, and H.L. Weiner Oral CD3-specific antibody suppresses autoimmune encephalomyelitis by inducing CD4+CD25-LAP+ T cells Nat. Med. 12 2006 627 635
170. E.S. Khafagy, M. Morishita, Y. Onuki, and K. Takayama Current challenges in non-invasive insulin delivery systems: a comparative review Adv. Drug Del. Rev. 59 2007 1521 1546
171. A. des Rieux, V. Fievez, M. Garinot, Y.J. Schneider, and V. Preat Nanoparticles as potential oral delivery systems of proteins and vaccines: a mechanistic approach J. Control. Rel. 116 2006 1 27
172. G. Hussack, T. Hirama, W. Ding, R. MacKenzie, and J. Tanha Engineered single-domain antibodies with high protease resistance and thermal stability PLoS ONE 6 2011 e28218
173. M. Shimizu, Y. Miwa, K. Hashimoto, and A. Goto Encapsulation of chicken egg yolk immunoglobulin G (IgY) by liposomes Biosci. Biotechnol. Biochem. 57 1993 1445 1449
174. M. Shimizu, R.C. Fitzsimmons, and S. Nakai Anti-E. coli lmmunoglobulin Y isolated from egg yolk of immunized chickens as a potential food ingredient J. Food Sci. 53 1988 1360 1368
175. X.Y. Li, L.J. Jin, T.A. McAllister, K. Stanford, J.Y. Xu, Y.N. Lu, Y.H. Zhen, Y.X. Sun, and Y.P. Xu Chitosan-alginate microcapsules for oral delivery of egg yolk immunoglobulin (IgY) J. Agric. Food Chem. 55 2007 2911 2917
176. H.W. Sung, K. Sonaje, Z.X. Liao, L.W. Hsu, and E.Y. Chuang PH-responsive nanoparticles shelled with chitosan for oral delivery of insulin: from mechanism to therapeutic applications Acc. Chem. Res. 45 2012 619 629
177. Y. Yun, Y.W. Cho, and K. Park Nanoparticles for oral delivery: targeted nanoparticles with peptidic ligands for oral protein delivery Adv. Drug Del. Rev. 65 2013 822 832
178. L. Dellamary, D.J. Smith, A. Bloom, S. Bot, G.R. Guo, H. Deshmuk, M. Costello, and A. Bot Rational design of solid aerosols for immunoglobulin delivery by modulation of aerodynamic and release characteristics J. Control. Rel. 95 2004 489 500
179. J. Patton Breathing life into protein drugs Nat. Biotechnol. 16 1998 141 143
180. M.I. Ugwoke, I.J. Vereyken, and H. Huessen Microparticles and Liposomes as Pulmonary Drug Delivery Systems: What Are the Recent Trends? Pulmonary Drug Delivery: Basics, Applications and Opportunities for Small Molecules and Biopharmaceutics 2007 Editio Cantor Vcrlag Aulendorf
181. A.J. Bitonti, J.A. Dumont, S.C. Low, R.T. Peters, K.E. Kropp, V.J. Palombella, J.M. Stattel, Y. Lu, C.A. Tan, J.J. Song, A.M. Garcia, N.E. Simister, G.M. Spiekermann, W.I. Lencer, and R.S. Blumberg Pulmonary delivery of an erythropoietin Fc fusion protein in non-human primates through an immunoglobulin transport pathway Proc. Natl. Acad. Sci. U. S. A. 101 2004 9763 9768
182. R.W. Niven Delivery of biotherapeutics by inhalation aerosol Crit. Rev. Ther. Drug Carrier Syst. 12 1995 151 231
183. R. Uchenna Agu, M. Ikechukwu Ugwoke, M. Armand, R. Kinget, and N. Verbeke The lung as a route for systemic delivery of therapeutic proteins and peptides Respir. Res. 2 2001 198 209
184. H. Chrystyn Is total particle dose more important than particle distribution? Respir. Med. 91 1997 17 19 1-11-1997
185. S. White, DB. Bennett, S. Cheu, P.W. Conley, D.B. Guzek, S. Gray, J. Howard, R. Malcolmson, J.M. Parker, P. Robert, N. Sadrzadeh, J.D. Schumacher, S. Seshadri, G.W. Sluggett, C.L. Stevenson, and N.J. Harper EXUBERA®: pharmaceutical development of a novel product for pulmonary delivery of insulin Diabetes Technol. Ther. 2005 896 906
186. J. Fahy, D. Cockcroft, LP. Boulet, H. Wong, F. Deschesnes, E. Davis, J. Ruppel, J. Su, and D. Adelman Effect of aerosolized anti-IgE (E25) on airway responses to inhaled allergen in asthmatic subjects Am. J. Respir. Crit. Care Med. 160 1999 1023 1027
187. T.M. Allen, and P.R. Cullis Liposomal drug delivery systems: from concept to clinical applications Adv. Drug Del. Rev. 65 2013 36 48
188. M. Smola, T. Vandamme, and A. Sokolowski Nanocarriers as pulmonary drug delivery systems to treat and to diagnose respiratory and non respiratory diseases Int. J. Nanomedicine 3 2008 1 19
189. A. Bot, T. Tarara, D. Smith, S. Bot, C. Woods, and J. Weers Novel lipid-based hollow-porous microparticles as a platform for immunoglobulin delivery to the respiratory tract Pharm. Res. 17 2000 275 283
190. W. Wang Protein aggregation and its inhibition in biopharmaceutics Int. J. Pharm. 289 2005 1 30
191. P. Homayoun, T. Mandal, D. Landry, and H. Komiskey Controlled release of anti-cocaine catalytic antibody from biodegradable polymer microspheres J. Pharm. Pharmacol. 55 2003 933 938
192. D. Schweizer, I. Vostiar, A. Heier, T. Serno, K. Schoenhammer, M. Jahn, S. Jones, A. Piequet, C. Beerli, H. Gram, and A. Goepferich Pharmacokinetics, biocompatibility and bioavailability of a controlled release monoclonal antibody formulation J. Control. Rel. 172 2013 975 982
193. C. Govardhan, N. Khalaf, C. Jung, B. Simeone, A. Higbie, S. Qu, L. Chemmalil, S. Pechenov, S. Basu, and A. Margolin Novel long-acting crystal formulation of human growth hormone Pharm. Res. 22 2005 1461 1470
194. L.J. Harris, E. Skaletsky, and A. McPherson Crystallization of intact monoclonal antibodies Proteins: Struct., Funct., Bioinf. 23 1995 285 289
195. D. Schweizer, K. Schoenhammer, M. Jahn, and A. Goepferich Protein-polyanion interactions for the controlled release of monoclonal antibodies Biomacromolecules 14 2013 75 83
196. K.A. Poelstra, N.A. Barekzi, A.M. Rediske, A.G. Felts, J.B. Slunt, and D.W. Grainger Prophylactic treatment of gram-positive and gram-negative abdominal implant infections using locally delivered polyclonal antibodies J. Biomed. Mater. Res. 60 2002 206 215
197. M. Doulazmi, D. Karagogeos, N. Gormand, M.T.r.s. Ternynck, N. Delhaye-Bouchaud, J. Mariani, and J.R. Bailly Sustained delivery of immunoglobulins from polymer microsources on a narrow surface of the developing rat brain J. Neurosci. Methods 84 1998 17 28
198. A. Konstantinos, A.G. Dorothy, F.H. Laura, K. Thomas, Immunomodulation, in: G. Huynh Thien Duc (Ed.), Melanoma - From Early Detection to Treatment, 2013.
199. W.M. Saltzman, and R. Langer Transport rates of proteins in porous materials with known microgeometry Biophys. J. 55 1989 163 171
200. R. Jalil, and J.R. Nixon Biodegradable poly(lactic acid) and poly(lactide-co-glycolide) microcapsules: problems associated with preparative techniques and release properties J. Microencapsulation 7 1990 297 325
201. M. van de Weert, W. Hennink, and W. Jiskoot Protein instability in poly(Lactic-co-Glycolic Acid) microparticles Pharm. Res. 17 2000 1159 1167
202. S. Son, W.R. Lee, Y.K. Joung, M.H. Kwon, Y.S. Kim, and K.D. Park Optimized stability retention of a monoclonal antibody in the PLGA nanoparticles Int. J. Pharm. 368 2009 178 185
203. J. Wang, K.M. Chua, and C.H. Wang Stabilization and encapsulation of human immunoglobulin G into biodegradable microspheres J. Colloid Interface Sci. 271 2004 92 101
204. K. Griebenow, and A.M. Klibanov On protein denaturation in aqueous-organic mixtures but not in pure organic solvents J. Am. Chem. Soc. 118 1996 11695 11700
205. A.M. Klibanov Why are enzymes less active in organic solvents than in water? Trends Biotechnol. 15 1997 97 101
206. M. Ye, S. Kim, and K. Park Issues in long-term protein delivery using biodegradable microparticles J. Control. Rel. 146 2010 241 260
207. A.S. Determan, J.H. Wilson, M.J. Kipper, M.J. Wannemuehler, and B. Narasimhan Protein stability in the presence of polymer degradation products: Consequences for controlled release formulations Biomaterials 27 2006 3312 3320
208. M.C. Lai, and E.M. Topp Solid-state chemical stability of proteins and peptides J. Pharm. Sci. 88 1999 489 500
209. G. Crotts, and T.G. Park Protein delivery from poly(lactic-co-glycolic acid) biodegradable microspheres: release kinetics and stability issues J. Microencapsulation 15 1998 699 713
210. T.G. Park, H. Yong, Lee, and Y. Sung Nam A new preparation method for protein loaded poly(d, l-lactic-co-glycolic acid) microspheres and protein release mechanism study J. Control. Rel. 55 1998 181 191
211. A. Lucke, J. Kiermaier, and A. Goepferich Peptide acylation by poly(hydroxy esters) Pharm. Res. 19 2002 175 181
212. A. Lucke, E. Fustella, J. Tessmar, A. Gazzaniga, and A. Goepferich The effect of poly(ethylene glycol)-poly(d, l-lactic acid) diblock copolymers on peptide acylation J. Control. Rel. 80 2002 157 168
213. S. Kempe, and K. Maeder In situ forming implants - an attractive formulation principle for parenteral depot formulations J. Control. Rel. 161 2012 668 679
214. S. Koutsopoulos, and S. Zhang Two-layered injectable self-assembling peptide scaffold hydrogels for long-term sustained release of human antibodies J. Control. Rel. 160 2012 451 458
215. S. Koutsopoulos, L.D. Unsworth, Y. Nagai, and S. Zhang Controlled release of functional proteins through designer self-assembling peptide nanofiber hydrogel scaffold Proc. Natl. Acad. Sci. U. S. A. 106 2009 4623 4628
216. Q. Lu, X. Wang, X. Hu, P. Cebe, F. Omenetto, and D.L. Kaplan Stabilization and release of enzymes from silk films Macromol. Biosci. 10 2010 359 368
217. S. Lu, X. Wang, Q. Lu, X. Hu, N. Uppal, F.G. Omenetto, and D.L. Kaplan Stabilization of enzymes in silk films Biomacromolecules 10 2009 1032 1042
218. N. Guziewicz, A. Best, B. Perez-Ramirez, and D.L. Kaplan Lyophilized silk fibroin hydrogels for the sustained local delivery of therapeutic monoclonal antibodies Biomaterials 32 2011 2642 2650
219. O. Franssen, L. Vandervennet, P. Roders, and W.E. Hennink Degradable dextran hydrogels: controlled release of a model protein from cylinders and microspheres J. Control. Rel. 60 1999 211 221
220. W. Jiskoot, T.W. Randolph, D.B. Volkin, C.R. Middaugh, C. Schoeneich, G. Winter, W. Friess, D.J.A. Crommelin, and J.F. Carpenter Protein instability and immunogenicity: roadblocks to clinical application of injectable protein delivery systems for sustained release J. Pharm. Sci. 101 2012 946 954
221. A. Olichon, D. Schweizer, S. Muyldermans, and A. de Marco Heating as a rapid purification method for recovering correctly-folded thermotolerant VH and VHH domains BMC Biotechnol. 7 2007 1 8
222. E. Rosenqvist, T. Jossang, and J. Feder Thermal properties of human IgG Mol. Immunol. 24 1987 495 501
223. Ophthalmic Ointments/Ophthalmic Preparations-Quality Tests <771>. The United States Pharmacopoeial Convention, Inc. [USP 36-NF 31], 2013.
224. Particulate Matter in Ophthalmic Solutions <789>, The United States Pharmacopoeial Convention, Inc. [USP 36-NF 31], 2013.
225. J. Carpenter, M. Pikal, B. Chang, and T. Randolph Rational design of stable lyophilized protein formulations: some practical advice Pharm. Res. 14 1997 969 975
226. W. Wang Lyophilization and development of solid protein pharmaceuticals Int. J. Pharm. 203 2000 1 60
227. J. Batra, K. Xu, S. Qin, and H.X. Zhou Effect of macromolecular crowding on protein binding stability: modest stabilization and significant biological consequences Biophys. J. 97 2009 906 911
228. S.A. Charman, A.M. Segrave, G.A. Edwards, and C.J. Porter Systemic availability and lymphatic transport of human growth hormone administered by subcutaneous injection J. Pharm. Sci. 2000
229. M. Parent, C. Nouvel, M. Koerber, A. Sapin, P. Maincent, and A. Boudier PLGA in situ implants formed by phase inversion: critical physicochemical parameters to modulate drug release J. Control. Rel. 2013
230. R.B. Patel, L. Solorio, H. Wu, T. Krupka, and A.A. Exner Effect of injection site on in situ implant formation and drug release in vivo J. Control. Rel. 147 2010 350 358
231. P.K. Working, Potential effects of antibody induction by protein drugs, in: B.L. Ferraiola, M. Mohler, C. Gloff (Eds.), Protein Pharmacokinetics and Metabolism, 1992, pp. 73-92.
232. H. Schellenkens The Immunogenicity of therapeutic proteins Discov. Med. 9 2010 560 564
233. K. Kotliar, M. Maier, S. Bauer, N. Feucht, C. Lohmann, and I. Lanzl Effect of intravitreal injections and volume changes on intraocular pressure: clinical results and biomechanical model Acta Ophthal. Scand. 85 2007 777 781
234. M. Saint-Geniez, A.S.R. Maharaj, T.E. Walshe, B.A. Tucker, E. Sekiyama, T. Kurihara, D.C. Darland, M.J. Young, and P.A. D'Amore Endogenous VEGF is required for visual function: evidence for a survival role on Mueller cells and photoreceptors PLoS ONE 3 2008 e3554
235. L. Joseph, S. Martin, P. Kolhe, and K. Muthurania Development of Syringeability Guide for Subcutaneous Protein Formulations 2010 AAPS
236. J.L. Cleland Immunogenicity and injection site consideration Protein Deliv.: Phys. Syst. 1997 30 34
237. A. Hatefi, and B. Amsden Biodegradable injectable in situ forming drug delivery systems J. Control. Release 80 2002 9 28
238. W. Rungseevijitprapa, and R. Bodmeier Injectability of biodegradable in situ forming microparticle systems (ISM) Eur. J. Pharm. Sci. 36 2009 524 531
239. D. Pasqui, M. De Cagna, and R. Barbucci Polysaccharide-based hydrogels: the key role of water in affecting mechanical properties Polymers 2012 1517 1537
240. A. Saluja, and D.S. Kalonia Nature and consequences of protein-protein interactions in high protein concentration solutions Int. J. Pharm. 358 2008 1 15
241. Z. Guo, A. Chen, R. Nassar, B. Helk, C. Mueller, Y. Tang, K. Gupta, and A. Klibanov Structure-activity relationship for hydrophobic salts as viscosity-lowering excipients for concentrated solutions of monoclonal antibodies Pharm. Res. 29 2012 3102 3109
242. S. Girish, M. Gupta, B. Wang, D. Lu, I. Krop, C. Vogel, H. Burris III, P. LoRusso, J.H. Yi, O. Saad, B. Tong, Y.W. Chu, S. Holden, and A. Joshi Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody-drug conjugate in development for the treatment of HER2-positive cancer Cancer Chemother. Pharmacol. 69 2012 1229 1240
243. M. Baker, and S. Stephens Investigation of the pharmacokinetic properties of certolizumab pegol, an anti-TNF agent Am. J. Gastroenterol. 101 2006 437
244. N. Thalayasingam, and J.D. Isaacs Anti-TNF therapy Best Pract. Res. Clinical Rheumatol. 25 2011 549 567
245. P. Ruf, M. Kluge, M. Jaeger, A. Burges, C. Volovat, M.M. Heiss, J. Hess, P. Wimberger, B. Brandt, and H. Lindhofer Pharmacokinetics, immunogenicity and bioactivity of the therapeutic antibody catumaxomab intraperitoneally administered to cancer patients Br. J. Clin. Pharmacol. 69 2010 617 625
246. J.A. Francisco, G.J. Schreiber, C.R. Comereski, L.E. Mezza, G.L. Warner, T.J. Davidson, J.A. Ledbetter, and C.B. Siegall In vivo efficacy and toxicity of a single-chain immunotoxin targeted to CD40 Blood 89 1997 4493 4500
247. J.C.K. Fitch, S. Rollins, L. Matis, B. Alford, S. Aranki, C.D. Collard, M. Dewar, J. Elefteriades, R. Hines, G. Kopf, P. Kraker, L. Li, R.O Hara, C. Rinder, H. Rinder, R. Shaw, B. Smith, G. Stahl, S.K. Shernan, Pharmacology and biological efficacy of a recombinant, humanized, single-chain antibody C5 complement inhibitor in patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass, Circulation 100 (1999) 24992506.