Impact of residual impurities and contaminants on protein stability

Journal of Pharmaceutical Sciences

Volumn 103, Issue 5, 2014, Pages 1315-1330

  Wang, Wei ^a   Ignatius, Arun Alphonse ^a   Thakkar, Santosh V ^a  

^a PFIZER INC   (United States)

Author keywords

biotechnology; deamidation; formulation; oxidation; protein aggregation

Indexed keywords

CALCIUM CHLORIDE; CARBOHYDRATE; CARBON DIOXIDE; CELL PROTEIN; COPPER CHLORIDE; EXCIPIENT; FATTY ACID; FERRIC CHLORIDE; FORMALDEHYDE; FORMIC ACID; FREE RADICAL; GLASS; HYPOCHLOROUS ACID; LIPID; MAGNESIUM CHLORIDE; METAL; NUCLEIC ACID; ORGANIC SOLVENT; OXYGEN; PERACETIC ACID; PEROXIDE; POLYOL; PROTEINASE; PROTEINASE INHIBITOR; RECOMBINANT PROTEIN; SILICONE OIL; TUNGSTEN; UNINDEXED DRUG; ZINC CHLORIDE;

ACIDIFICATION; ADSORPTION; BIOTECHNOLOGICAL PRODUCTION; CLEANING; CONTAINER; DEAMINATION; DISPOSABLE EQUIPMENT; DRUG CONTAMINATION; DRUG IMPURITY; DRUG MANUFACTURE; DRUG PACKAGING; DRUG PURIFICATION; DRUG STORAGE; EQUIPMENT; GLYCATION; HOST CELL; ILLUMINATION; IRRADIATION; MOISTURE; OXIDATION; PACKAGING MATERIAL; PROCESS OPTIMIZATION; PRODUCT DEVELOPMENT; PROTEIN AGGREGATION; PROTEIN DEGRADATION; PROTEIN QUALITY; PROTEIN STABILITY; REVIEW; SUPERCRITICAL FLUID; SYRINGE; WASTE MANAGEMENT; BIOTECHNOLOGY; CHEMISTRY; HUMAN;

BIOTECHNOLOGY; DRUG CONTAMINATION; HUMANS; PROTEIN STABILITY; RECOMBINANT PROTEINS;

EID: 84898007468     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23931     Document Type: Short Survey

References (222)

1. Huang LY, Dumontelle JL, Zolodz M, Deora A, Mozier NM, Golding B,. 2009. Use of toll-like receptor assays to detect and identify microbial contaminants in biological products. J Clin Microbiol 47 (11): 3427-3434.
2. Mugoyela V, Mwambete KD,. 2010. Microbial contamination of nonsterile pharmaceuticals in public hospital settings. Ther Clin Risk Managt 6: 443-448.
3. Guerrini M, Beccati D, Shriver Z, Naggi A, Viswanathan K, Bisio A, Capila I, Lansing JC, Guglieri S, Fraser B, Al-Hakim A, Gunay NS, Zhang Z, Robinson L, Buhse L, Nasr M, Woodcock J, Langer R, Venkataraman G, Linhardt RJ, Casu B, Torri G, Sasisekharan R,. 2008. Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events. Nat Biotechnol 26 (6): 669-675.
4. Blossom DB, Kallen AJ, Patel PR, Elward A, Robinson L, Gao G, Langer R, Perkins KM, Jaeger JL, Kurkjian KM, Jones M, Schillie SF, Shehab N, Ketterer D, Venkataraman G, Kishimoto TK, Shriver Z, McMahon AW, Austen KF, Kozlowski S, Srinivasan A, Turabelidze G, Gould CV, Arduino MJ, Sasisekharan R,. 2008. Outbreak of adverse reactions associated with contaminated heparin. New Engl J Med 359 (25): 2674-2684.
5. Liu Z, Xiao Z, Masuko S, Zhao W, Sterner E, Bansal V, Fareed J, Dordick J, Zhang F, Linhardt RJ,. 2011. Mass balance analysis of contaminated heparin product. Anal Biochem 408 (1): 147-156.
6. Murphy BM, Swarts S, Mueller BM, van der Geer P, Manning MC, Fitchmun MI,. 2013. Protein instability following transport or storage on dry ice. Nat Methods 10 (4): 278-279.
7. Kirsch LE, Riggin RM, Gearhart DA, Lefeber DS, Lytle DL,. 1993. In-process protein degradation by exposure to trace amounts of sanitizing agents. J Parenter Sci Technol 47 (4): 155-160.
8. Wang W, Cui TY, Wang YJ, Martin-Moe S,. 2004. Oxidation of protein by vaporized sanitizing agents. PDA J Pharm Sci Technol 58 (3): 121-129.
9. Nassar MN, Nesarikar VN, Lozano R, Parker WL, Huang Y, Palaniswamy V, Xu W, Khaselev N,. 2004. Influence of formaldehyde impurity in polysorbate 80 and PEG-300 on the stability of a parenteral formulation of BMS-204352: Identification and control of the degradation product. Pharm Dev Technol 9 (2): 189-195.
10. Pan C, Liu F, Motto M,. 2010. Identification of pharmaceutical impurities in formulated dosage forms. J Pharm Sci 100 (4): 1228-1259.
11. Gorbenko GP, Ioffe VM, Kinnunen PK,. 2007. Binding of lysozyme to phospholipid bilayers: Evidence for protein aggregation upon membrane association. Biophys J 93 (1): 140-153.
12. Grudzielanek S, Smirnovas V, Winter R,. 2007. The effects of various membrane physical-chemical properties on the aggregation kinetics of insulin. Chem Phys Lipids 149 (1-2): 28-39.
13. Kishore RS, Pappenberger A, Dauphin IB, Ross A, Buergi B, Staempfli A, Mahler HC,. 2011. Degradation of polysorbates 20 and 80: Studies on thermal autoxidation and hydrolysis. J Pharm Sci 100 (2): 721-731.
14. Zhou S, Mozziconacci O, Kerwin BA, Schoneich C,. 2013. The photolysis of disulfide bonds in IgG1 and IgG2 leads to selective intramolecular hydrogen transfer reactions of cysteine Thiyl radicals, probed by covalent H/D exchange and RPLC-MS/MS analysis. Pharm Res 30 (5): 1291-1299.
15. Agarkhed M, O'Dell C, Hsieh MC, Zhang J, Goldstein J, Srivastava A,. 2013. Effect of polysorbate 80 concentration on thermal and photostability of a monoclonal antibody. AAPS Pharm Sci Tech 14 (1): 1-9.
16. Li N, Osborne B, Singh SK, Wang W,. 2012. Metal-leachate-induced conjugate protein instability. J Pharm Sci 101 (8): 2733-2743.
17. Zhou S, Schoneich C, Singh SK,. 2011. Biologics formulation factors affecting metal leachables from stainless steel. AAPS PharmSciTech 12 (1): 411-421.
18. Rustandi RR, Wang Y,. 2011. Use of CE-SDS gel for characterization of monoclonal antibody hinge region clipping due to copper and high pH stress. Electrophoresis 32 (21): 3078-3084.
19. Sasaki H, Kikuchi J, Maeda T, Kuboniwa H,. 2010. Impact of different elastomer formulations on moisture permeation through stoppers used for lyophilized products stored under humid conditions. PDA J Pharm Sci Technol 64 (1): 63-70.
20. Tsui V, Somma MS, Zitzner LA,. 2009. Leachables evaluation for bulk drug substance. PDA J Pharm Sci Technol 63 (2): 168-183.
21. Fliszar KA, Walker D, Allain L,. 2006. Profiling of metal ions leached from pharmaceutical packaging materials. PDA J Pharm Sci and Technol 60 (6): 337-342.
22. Huang M, Horwitz TS, Zweiben C, Singh SK,. 2011. Impact of extractables/leachables from filters on stability of protein formulations. J Pharm Sci 100 (11): 4617-4630.
23. N'Soukpoe-Kossi CN, Diamantoglou S, Tajmir-Riahi HA,. 2008. DNase I-DNA interaction alters DNA and protein conformations. Biochem Cell Biol 86 (3): 244-250.
24. N'Soukpoe-Kossi CN, Ragi C, Tajmir-Riahi HA,. 2007. DNA interaction with RNase A alters protein conformation. DNA Cell Biol 26 (1): 28-35.
25. Khabiri M, Minofar B, Brezovsky J, Damborsky J, Ettrich R,. 2012. Interaction of organic solvents with protein structures at protein-solvent interface. J Mol Model.
26. Qadry SS, Roshdy TH, Knox DE, Phillips EM,. 1999. Model development for O(2) and N(2) permeation rates through CZ-resin vials. Int J Pharm 188 (2): 173-179.
27. Iacocca RG, Toltl N, Allgeier M, Bustard B, Dong X, Foubert M, Hofer J, Peoples S, Shelbourn T,. 2010. Factors affecting the chemical durability of glass used in the pharmaceutical industry. AAPS Pharm Sci Tech 11 (3): 1340-1349.
28. Hoehne M, Samuel F, Dong A, Wurth C, Mahler H-C, Carpenter JF, Randolph TW,. 2011. Adsorption of monoclonal antibodies to glass microparticles. J Pharm Sci 100 (1): 123-132.
29. Liu L, Randolph TW, Carpenter JF,. 2012. Particles shed from syringe filters and their effects on agitation-induced protein aggregation. J Pharm Sci 101 (8): 2952-2959.
30. Bee JS, Chiu D, Sawicki S, Stevenson JL, Chatterjee K, Freund E, Carpenter JF, Randolph TW,. 2009. Monoclonal antibody interactions with micro- and nanoparticles: Adsorption, aggregation, and accelerated stress studies. J Pharm Sci 98 (9): 3218-3238.
31. Bee JS, Davis M, Freund E, Carpenter JF, Randolph TW,. 2010. Aggregation of a monoclonal antibody induced by adsorption to stainless steel. Biotechnol Bioeng 105 (1): 121-129.
32. Ha E, Wang W, Wang YJ,. 2002. Peroxide formation in polysorbate 80 and protein stability. J Pharm Sci 91 (10): 2252-2264.
33. Schenauer MR, Flynn GC, Goetze AM,. 2012. Identification and quantification of host cell protein impurities in biotherapeutics using mass spectrometry. Anal Biochem.
34. Senderoff RI, Kontor KM, Heffernan JK, Clarke HJ, Garrison LK, Kreilgaard L, Lasser GW, Rosenberg GB,. 1996. Aqueous stability of recombinant human thrombopoietin as a function of processing schemes. J Pharm Sci 85 (7): 749-752.
35. Gao SX, Zhang Y, Stansberry-Perkins K, Buko A, Bai S, Nguyen V, Brader ML,. 2011. Fragmentation of a highly purified monoclonal antibody attributed to residual CHO cell protease activity. Biotechnol Bioeng 108 (4): 977-982.
36. Miller AK, Hambly DM, Kerwin BA, Treuheit MJ, Gadgil HS,. 2011. Characterization of site-specific glycation during process development of a human therapeutic monoclonal antibody. J Pharm Sci 100 (7): 2543-2550.
37. Oliveira LMA, Gomes RA, Yang D, Dennison SR, Familia C, Lages A, Coelho AV, Murphy RM, Phoenix DA, Quintas A,. 2013. Insights into the molecular mechanism of protein native-like aggregation upon glycation. Biochim Biophys Acta 1834: 1010-1022.
38. Liu G, Zhong Q,. 2012. Glycation of whey protein to provide steric hindrance against thermal aggregation. J Agric Food Chem 60: 9754-9762.
39. Dixit N, Maloney KM, Kalonia DS,. 2012. The effect of Tween (R) 20 on silicone oil-fusion protein interactions. Int J Pharm 429 (1-2): 158-167.
40. 1 aggregation and particle formation induced by silicone-water interfaces on siliconized borosilicate glass beads: A model for siliconized primary containers. J Pharm Sci 102 (3): 852-865.
41. Jiang Y, Nashed-Samuel Y, Li C, Liu W, Pollastrini J, Mallard D, Wen ZQ, Fujimori K, Pallitto M, Donahue L, Chu G, Torraca G, Vance A, Mire-Sluis T, Freund E, Davis J, Narhi L,. 2009. Tungsten-induced protein aggregation: Solution behavior. J Pharm Sci 98 (12): 4695-4710.
42. Seidl A, Hainzl O, Richter M, Fischer R, Bohm S, Deutel B, Hartinger M, Windisch J, Casadevall N, London GM, Macdougall I,. 2011. Tungsten-induced denaturation and aggregation of Epoetin Alfa during primary packaging as a cause of immunogenicity. Pharm Res 29 (6): 1454-1467.
43. McGuffey MK, Epting KL, Kelly RM, Foegeding EA,. 2005. Denaturation and aggregation of three alpha-lactalbumin preparations at neutral pH. J Agric Food Chem 53 (8): 3182-3190.
44. McGuffey MK, Otter DE, Zanten JHv, Foegeding EA,. 2007. Solubility and aggregation of commercial alpha-lactalbumin at neutral pH. Int Dairy J 17 (10): 1168-1178.
45. Judge RA, Forsythe EL, Pusey ML,. 1998. The effect of protein impurities on lysozyme crystal growth. Biotechnol Bioeng 59 (6): 776-785.
46. van den Berg HA, Rand DA,. 2004. Foreignness as a matter of degree: The relative immunogenicity of peptide/MHC ligands. J Theoret Biol 231 (4): 535-548.
47. Kanduc D,. 2008. Immunogenicity in peptide-immunotherapy: From self/nonself to similar/dissimilar sequences. Adv Exp Med Biol 640: 198-207.
48. Giese A, Bader B, Bieschke J, Schaffar G, Odoy S, Kahle PJ, Haass C, Kretzschmar H,. 2005. Single particle detection and characterization of synuclein co- aggregation. Biochem Biophys Res Commun 333 (4): 1202-1210.
49. Schokker EP, Singh H, Creamer LK,. 2000. Heat-induced aggregation of beta-lactoglobulin A and B with alpha- lactalbumin. Int Dairy J 10 (12): 843-853.
50. Suomela H,. 1991. Stability of European anti-D immunoglobulin preparations. Vox Sang 60 (2): 69-74.
51. Richter W, Hermsdorf T, Lilie H, Egerland U, Rudolph R, Kronbach T, Dettmer D,. 2000. Refolding, purification, and characterization of human recombinant PDE4A constructs expressed in Escherichia coli. Protein Expr Purif 19 (3): 375-383.
52. Lauer TM, Agrawal NJ, Chennamsetty N, Egodage K, Helk B, Trout BL,. 2012. Developability index: A rapid in silico tool for the screening of antibody aggregation propensity. J Pharm Sci 101 (1): 102-115.
53. Creusot N, Gruppen H,. 2007. Enzyme-induced aggregation and gelation of proteins. Biotechnol Adv 25 (6): 597-601.
54. Singh P, Singh MK, Chauhan V, Gupta P, Dhaked RK,. 2011. Prevention of aggregation and autocatalysis for sustaining biological activity of recombinant BoNT/A-LC upon long-term storage. Protein Pept Lett 18 (12): 1177-1187.
55. Fujimori S, Hino K, Saito A, Miyano S, Miyamoto-Sato E,. 2012. PRD: A protein-RNA interaction database. Bioinformation 8 (15): 729-730.
56. Goldfless SJ, Belmont BJ, de Paz AM, Liu JF, Niles JC,. 2012. Direct and specific chemical control of eukaryotic translation with a synthetic RNA-protein interaction. Nucleic Acids Res 40 (9): e64.
57. Cai YH, Huang H,. 2012. Advances in the study of protein-DNA interaction. Amino Acids 43 (3): 1141-1146.
58. Zhang Z, Gong Y, Guo L, Jiang T, Huang L,. 2010. Structural insights into the interaction of the crenarchaeal chromatin protein Cren7 with DNA. Mol Microbiol 76 (3): 749-759.
59. Joshi B, Chakrabarty A, Bruot C, Ainsworth H, Fraizer G, Wei QH,. 2010. DNA-WT1 protein interaction studied by surface-enhanced Raman spectroscopy. Anal Bioanal Chem 396 (4): 1415-1421.
60. Simicevic J, Deplancke B,. 2010. DNA-centered approaches to characterize regulatory protein-DNA interaction complexes. Mol bioSyst 6 (3): 462-468.
61. Kunzelmann S, Morris C, Chavda AP, Eccleston JF, Webb MR,. 2010. Mechanism of interaction between single-stranded DNA binding protein and DNA. Biochemistry 49 (5): 843-852.
62. Arunkumar AI, Stauffer ME, Bochkareva E, Bochkarev A, Chazin WJ,. 2003. Independent and coordinated functions of replication protein A tandem high affinity single-stranded DNA binding domains. J Biol Chem 278 (42): 41077-41082.
63. Morimatsu K, Funakoshi T, Horii T, Takahashi M,. 2001. Interaction of tyrosine 65 of RecA protein with the first and second DNA strands. J Mol Biol 306 (2): 189-199.
64. Arunkumar AI, Campanello GC, Giedroc DP,. 2009. Solution structure of a paradigm ArsR family zinc sensor in the DNA-bound state. Proc Natl Acad Sci USA 106 (43): 18177-18182.
65. Jain NK, Jetani HC, Roy I,. 2013. Nucleic acid aptamers as stabilizers of proteins: The stability of tetanus toxoid. Pharm Res 30 (7): 1871-1882.
66. Malik R, Roy I,. 2013. Stabilization of bovine insulin against agitation-induced aggregation using RNA aptamers. Int J Pharm 452 (1-2): 257-265.
67. Himanen JP, Sarvas M, Helander IM,. 1993. Assessment of non-protein impurities in potential vaccine proteins produced by Bacillus subtilis. Vaccine 11 (9): 970-973.
68. Tong HF, Lin DQ, Gao D, Yuan XM, Yao SJ,. 2013. Caprylate as the albumin-selective modifier to improve IgG purification with hydrophobic charge-induction chromatography. J Chromatogr A 1285: 88-96.
69. Johnston A, Uren E, Johnstone D, Wu J,. 2003. Low pH, caprylate incubation as a second viral inactivation step in the manufacture of albumin. Parametric and validation studies. Biologicals 31 (3): 213-221.
70. Yoo HS, Choi HK, Park TG,. 2001. Protein-fatty acid complex for enhanced loading and stability within biodegradable nanoparticles. J Pharm Sci 90 (2): 194-201.
71. Stange J, Stiffel M, Goetze A, Strube S, Gruenert J, Klammt S, Mitzner S, Koball S, Liebe S, Reisinger E,. 2011. Industrial stabilizers caprylate and N-acetyltryptophanate reduce the efficacy of albumin in liver patients. Liver Transpl 17 (6): 705-709.
72. Arakawa T, Kita Y,. 2000. Stabilizing effects of caprylate and acetyltryptophanate on heat-induced aggregation of bovine serum albumin. Biochim Biophys Acta 1479 (1-2): 32-36.
73. Haque F, Pandey AP, Cambrea LR, Rochet JC, Hovis JS,. 2010. Adsorption of alpha-synuclein on lipid bilayers: Modulating the structure and stability of protein assemblies. J Phys Chem B 114 (11): 4070-4081.
74. Litt J, Padala C, Asuri P, Vutukuru S, Athmakuri K, Kumar S, Dordick J, Kane RS,. 2009. Enhancing protein stability by adsorption onto raftlike lipid domains. J Am Chem Soc 131 (20): 7107-7111.
75. Lo Y-L, Rahman Y-E,. 1998. Effect of lipids on the thermal stability and conformational changes of proteins: Ribonuclease A and cytochrome c. Int J Pharm 161 (2): 137-148.
76. Smith SM,. 2011. Strategies for the purification of membrane proteins. Methods Mol Biol 681: 485-496.
77. Kragh-Hansen U,. 1993. A micromethod for delipidation of aqueous proteins. Anal Biochem 210 (2): 318-327.
78. Dartar, Oztan M, Akman AA, Zaimoglu L, Bilgic S,. 2002. Corrosion rates of stainless-steel files in different irrigating solutions. Int Endodontic J 35 (8): 655-659.
79. Kocijan A, Milosev I, Pihlar B,. 2003. The influence of complexing agent and proteins on the corrosion of stainless steels and their metal components. J Mater Sci Mater Med 14 (1): 69-77.
80. Lam XM, Yang JY, Cleland JL,. 1997. Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody HER2. J Pharm Sci 86 (11): 1250-1255.
81. Zang L, Carlage T, Murphy D, Frenkel R, Bryngelson P, Madsen M, Lyubarskaya Y,. 2012. Residual metals cause variability in methionine oxidation measurements in protein pharmaceuticals using LC-UV/MS peptide mapping. J Chrom B 895-896: 71-76.
82. Kumar S, Zhou S, Singh SK,. 2013. Metal ion leachates and the physico-chemical stability of biotherapeutic drug products. Curr Pharm Des.
83. Fatouros A, Österberg T, Mikaelsson M,. 1997. Recombinant factor VIII SQ-influence of oxygen, metal ions, pH and ionic strength on its stability in aqueous solution. Int J Pharm 155 (1): 121-131.
84. Petit J, Herbig AL, Moreau A, Delaplace G,. 2011. Influence of calcium on beta-lactoglobulin denaturation kinetics: Implications in unfolding and aggregation mechanisms. J Dairy Sci 94 (12): 5794-5810.
85. Cooper BF, Sideraki V, Wilson DK, Dominguez DY, Clark SW, Quiocho FA, Rudolph FB,. 1997. The role of divalent cations in structure and function of murine adenosine deaminase. Protein Sci 6 (5): 1031-1037.
86. Bader B, Nubling G, Mehle A, Nobile S, Kretzschmar H, Giese A,. 2011. Single particle analysis of tau oligomer formation induced by metal ions and organic solvents. Biochem Biophys Res Commun 411 (1): 190-196.
87. Chan HK, Au-Yeung KL, Gonda I,. 1996. Effects of additives on heat denaturation of rhDNase in solutions. Pharm Res 13 (5): 756-761.
88. Chen B, Costantino HR, Liu J, Hsu CC, Shire SJ,. 1999. Influence of calcium ions on the structure and stability of recombinant human deoxyribonuclease I in the aqueous and lyophilized states. J Pharm Sci 88 (4): 477-482.
89. Rachmilovich-Calis S, Masarwa A, Meyerstein N, Meyerstein D, van Eldik R,. 2009. New mechanistic aspects of the Fenton reaction. Chemistry 15 (33): 8303-8309.
90. Li S, Nguyen TH, Schoneich C, Borchardt RT,. 1995. Aggregation and precipitation of human relaxin induced by metal-catalyzed oxidation. Biochemistry 34 (17): 5762-5772.
91. Ruiperez F, Mujika JI, Ugalde JM, Exley C, Lopez X,. 2012. Pro-oxidant activity of aluminum: Promoting the Fenton reaction by reducing Fe(III) to Fe(II). J Inorg Biochem 117: 118-123.
92. Stadtman ER, Levine RL,. 2003. Free radical-mediated oxidation of free amino acids and amino acid residues in proteins. Amino Acids 25 (3-4): 207-218.
93. Stadtman ER,. 1993. Oxidation of free amino acids and amino acid residues in proteins by radiolysis and by metal-catalyzed reactions. Annu Rev Biochem 62: 797-821.
94. Li S, Schoneich C, Borchardt RT,. 1995. Chemical instability of protein pharmaceuticals: Mechanisms of oxidation and strategies for stabilization. Biotechnol Bioeng 48 (5): 490-500.
95. Fransson J, Hagman A,. 1996. Oxidation of human insulin-like growth factor I in formulation studies, II. Effects of oxygen, visible light, and phosphate on methionine oxidation in aqueous solution and evaluation of possible mechanisms. Pharm Res 13 (10): 1476-1481.
96. Zang L, Carlage T, Murphy D, Frenkel R, Bryngelson P, Madsen M, Lyubarskaya Y,. 2012. Residual metals cause variability in methionine oxidation measurements in protein pharmaceuticals using LC-UV/MS peptide mapping. J Chromatogr B Analyt Technol Biomed Life Sci 895-896: 71-76.
97. Kanazawa H, Fujimoto S, Ohara A,. 1994. Effect of radical scavengers on the inactivation of papain by ascorbic acid in the presence of cupric ions. Biol Pharm Bull 17 (4): 476-481.
98. Zhao F, Ghezzo-Schoneich E, Aced GI, Hong J, Milby T, Schoneich C,. 1997. Metal-catalyzed oxidation of histidine in human growth hormone. Mechanism, isotope effects, and inhibition by a mild denaturing alcohol. J Biol Chem 272 (14): 9019-9029.
99. Miller DM, Buettner GR, Aust SD,. 1990. Transition metals as catalysts of "autoxidation" reactions. Free Radic Biol Med 8 (1): 95-108.
100. Yan B, Boyd D,. 2011. Breaking the light and heavy chain linkage of human immunoglobulin G1 (IgG1) by radical reactions. J Biol Chem 286 (28): 24674-24684.
101. Kwak EJ, Lim SI,. 2004. The effect of sugar, amino acid, metal ion, and NaCl on model Maillard reaction under pH control. Amino Acids 27 (1): 85-90.
102. 3-galactitol complex. J Inorg Biochem 83 (2-3): 161-167.
103. Saladini M, Menabue L, Ferrari E,. 2001. Sugar complexes with metal(2+) ions: Thermodynamic parameters of associations of Ca(2+), Mg(2+) and Zn(2+) with galactaric acid. Carbohydrate Res 336 (1): 55-61.
104. Zhou S, Zhang B, Sturm E, Teagarden DL, Schöneich C, Kolhe P, Lewis LM, Muralidhara BK, Singh SK,. 2010. Comparative evaluation of disodium edetate and diethylenetriaminepentaacetic acid as iron chelators to prevent metal-catalyzed destabilization of a therapeutic monoclonal antibody. J Pharm Sci 99 (10): 4239-4250.
105. Mozziconacci O, Ji JYA, Wang YJ, Schoneich C,. 2013. Metal-catalyzed oxidation of protein methionine residues in human parathyroid hormone (1-34): Formation of homocysteine and a novel methionine-dependent hydrolysis reaction. Mol Pharm 10 (2): 739-755.
106. Godfrey MA, Kwasowski P, Clift R, Marks V,. 1992. A sensitive enzyme-linked immunosorbent assay (ELISA) for the detection of staphylococcal protein A (SpA) present as a trace contaminant of murine immunoglobulins purified on immobilized protein A. J Immunol Methods 149 (1): 21-27.
107. Panwar P, Deniaud A, Pebay-Peyroula E,. 2012. Contamination from an affinity column: An encounter with a new villain in the world of membrane-protein crystallization. Acta Crystallogr D Biol Crystallogr 68 (Pt 10): 1272-1277.
108. Gefroh E, Hewig A, Vedantham G, McClure M, Krivosheyeva A, Lajmi A, Lu Y,. 2013. Multi-pronged approach to managing beta-glucan contaminants in the downstream process: Control of raw materials and filtration with charge-modified nylon 6, 6 membrane filters. Biotechnol Prog 29 (3): 672-680.
109. Ito T, Kikuta H, Nagamori E, Honda H, Ogino H, Ishikawa H, Kobayashi T,. 2001. Lipase production in two-step fed-batch culture of organic solvent-tolerant Pseudomonas aeruginosaLST-03. J Biosci Bioeng 91 (3): 245-250.
110. Karbalaei-Heidari HR, Ziaee AA, Amoozegar MA,. 2007. Purification and biochemical characterization of a protease secreted by the Salinivibrio sp. strain AF-2004 and its behavior in organic solvents. Extremophiles 11 (2): 237-243.
111. Yamamoto E, Yamaguchi S, Nagamune T,. 2011. Synergistic effects of detergents and organic solvents on protein refolding: Control of aggregation and folding rates. J Biosci Bioeng 111 (1): 10-15.
112. Xu B, Lundgren M, Magnusson AC, Fuentes A,. 2010. Expression, purification and characterization of the recombinant chimeric IgE Fc-fragment opossum-human-opossum (OSO), an active immunotherapeutic vaccine component. Protein Expr Purif 74 (1): 32-41.
113. Cornish J, Callon KE, Lin CQ, Xiao CL, Mulvey TB, Cooper GJ, Reid IR,. 1999. Trifluoroacetate, a contaminant in purified proteins, inhibits proliferation of osteoblasts and chondrocytes. Am J Physiol 277 (5 Pt 1): E779-E783.
114. Mattos C, Ringe D,. 2001. Proteins in organic solvents. Curr Opin Struct Biol 11 (6): 761-764.
115. Gladilin AK, Levashov AV,. 1998. Enzyme stability in systems with organic solvents. Biochemistry (Mosc) 63 (3): 345-356.
116. Simon LM, Laczko I, Demcsak A, Toth D, Kotorman M, Fulop L,. 2012. The formation of amyloid-like fibrils of alpha-chymotrypsin in different aqueous organic solvents. Protein Pept Lett 19 (5): 544-550.
117. Sukumar M, Storms SM, De Felippis MR,. 2005. Non-native intermediate conformational states of human growth hormone in the presence of organic solvents. Pharm Res 22 (5): 789-796.
118. Sen P, Ahmad B, Rabbani G, Khan RH,. 2010. 2,2,2-Trifluroethanol induces simultaneous increase in alpha-helicity and aggregation in alkaline unfolded state of bovine serum albumin. Int J Biol Macromol 46 (2): 250-254.
119. Rezaei-Ghaleh N, Ebrahim-Habibi A, Moosavi-Movahedi AA, Nemat-Gorgani M,. 2007. Role of electrostatic interactions in 2,2,2-trifluoroethanol-induced structural changes and aggregation of alpha-chymotrypsin. Arch Biochem Biophys 457 (2): 160-169.
120. Cellmer T, Douma R, Huebner A, Prausnitz J, Blanch H,. 2007. Kinetic studies of protein L aggregation and disaggregation. Biophys Chem 125 (2-3): 350-359.
121. Capanni C, Taddei N, Gabrielli S, Messori L, Orioli P, Chiti F, Stefania M, Ramponia G,. 2004. Investigation of the effects of copper ions on protein aggregation using a model system. Cell Mol Life Sci 61 (7-8): 982-991.
122. Amani M, Yousefi R, Moosavi-Movahedi AA, Pintus F, Mura A, Floris G, Kurganov BI, Saboury AA,. 2008. Structural changes and aggregation process of Cu/containing amine oxidase in the presence of 2,2,2-trifluoroethanol. Protein Pept Lett 15 (5): 521-527.
123. Amani S, Naeem A,. 2011. Acetonitrile can promote formation of different structural intermediate states on aggregation pathway of immunoglobulin G from human and bovine. Int J Biol Macromol 49: 71-78.
124. Chandrayan SK, Dhaunta N, Guptasarma P,. 2008. Expression, purification, refolding and characterization of a putative lysophospholipase from Pyrococcus furiosus: Retention of structure and lipase/esterase activity in the presence of water-miscible organic solvents at high temperatures. Protein Expr Purif 59 (2): 327-333.
125. Xia Y, Park YD, Mu H, Zhou HM, Wang XY, Meng FG,. 2007. The protective effects of osmolytes on arginine kinase unfolding and aggregation. Int J Biol Macromol 40 (5): 437-443.
126. Cholewinski M, Luckel B, Horn H,. 1996. Degradation pathways, analytical characterization and formulation strategies of a peptide and a protein. Calcitonine and human growth hormone in comparison. Pharm Acta Helv 71 (6): 405-419.
127. Feng S, Yan YB,. 2008. Effects of glycerol on the compaction and stability of the wild type and mutated rabbit muscle creatine kinase. Proteins 71 (2): 844-854.
128. Shukla AA, Gupta P, Han X,. 2007. Protein aggregation kinetics during Protein A chromatography. Case study for an Fc fusion protein. J Chromatogr 1171 (1-2): 22-28.
129. Khan S, Bhakuni V, Praveen V, Tewari R, Tripathi CK, Gupta VD,. 2010. Maximizing the native concentration and shelf life of protein: A multiobjective optimization to reduce aggregation. Appl Microbiol Biotechnol 89 (1): 99-108.
130. Carpenter JF, Crowe JH, Arakawa T,. 1990. Comparison of solute-induced protein stabilization in aqueous solution and in frozen and dried state. J Dairy Sci 73: 3527-3636.
131. Carpenter JF, Hand SC, Crowe LM, Crowe JH,. 1986. Cryoprotection of phosphofructokinase with organic solutes: Characterization of enhanced protection in the presence of divalent cations. Arch Biochem Biophys 250 (2): 505-512.
132. Wu Y, Levons J, Narang AS, Raghavan K, Rao VM,. 2011. Reactive impurities in excipients: Profiling, identification and mitigation of drug-excipient incompatibility. AAPS PharmSciTech 12 (4): 1248-1263.
133. Segura-Munoz SI, da Silva Oliveira A, Nikaido M, Trevilato TM, Bocio A, Takayanagui AM, Domingo JL,. 2006. Metal levels in sugar cane (Saccharum spp.) samples from an area under the influence of a municipal landfill and a medical waste treatment system in Brazil. Environ Int 32 (1): 52-57.
134. Mason BD, McCracken M, Bures EJ, Kerwin BA,. 2010. Oxidation of free l -histidine by tert-Butylhydroperoxide. Pharm Res 27 (3): 447-456.
135. Jaeger J, Sorensen K, Wolff SP,. 1994. Peroxide accumulation in detergents. J Biochem Biophys Methods 29 (1): 77-81.
136. Singh SR, Zhang JM, O'Dell C, Hsieh MC, Goldstein J, Liu J, Srivastava A,. 2012. Effect of polysorbate 80 quality on photostability of a monoclonal antibody. AAPS PharmSciTech 13 (2): 422-430.
137. Wasylaschuk WR, Harmon PA, Wagner G, Harman AB, Templeton AC, Xu H, Reed RA,. 2007. Evaluation of hydroperoxides in common pharmaceutical excipients. J Pharm Sci 96 (1): 106-116.
138. Kishore RS, Kiese S, Fischer S, Pappenberger A, Grauschopf U, Mahler HC,. 2011. The degradation of polysorbates 20 and 80 and its potential impact on the stability of biotherapeutics. Pharm Res 28 (5): 1194-1210.
139. Santana H, Gonzalez Y, Campana PT, Noda J, Amarantes O, Itri R, Beldarrain A, Paez R,. 2013. Screening for stability and compatibility conditions of recombinant human epidermal growth factor for parenteral formulation: Effect of pH, buffers, and excipients. Int J Pharm 452 (1-2): 52-62.
140. Hovorka S, Schoneich C,. 2001. Oxidative degradation of pharmaceuticals: Theory, mechanisms and inhibition. J Pharm Sci 90 (3): 253-269.
141. Knepp VM, Whatley JL, Muchnik A, Calderwood TS,. 1996. Identification of antioxidants for prevention of peroxide-mediated oxidation of recombinant human ciliary neurotrophic factor and recombinant human nerve growth factor. PDA J Pharm Sci Technol 50 (3): 163-171.
142. Hong J, Lee E, Carter JC, Masse JA, Oksanen DA,. 2004. Antioxidant-accelerated oxidative degradation: A case study of transition metal ion catalyzed oxidation in formulation. Pharm Dev Technol 9 (2): 171-179.
143. Chang HW, Bock E,. 1980. Pitfalls in the use of commercial nonionic detergents for the solubilization of integral membrane proteins: Sulfhydryl oxidizing contaminants and their elimination. Anal Biochem 104 (1): 112-117.
144. Herman AC, Boone TC, Lu HS,. 1996. Characterization, formulation, and stability of Neupogen (Filgrastim), a recombinant human granulocyte-colony stimulating factor. Pharm Biotechnol 9: 303-328.
145. del Barrio MA, Hu J, Zhou P, Cauchon N,. 2006. Simultaneous determination of formic acid and formaldehyde in pharmaceutical excipients using headspace GC/MS. J Pharm Biomed Anal 41 (3): 738-743.
146. Waterman KC, Arikpo WB, Fergione MB, Graul TW, Johnson BA, Macdonald BC, Roy MC, Timpano RJ,. 2008. N-methylation and N-formylation of a secondary amine drug (varenicline) in an osmotic tablet. J Pharm Sci 97 (4): 1499-1507.
147. Song Y, Schowen RL, Borchardt RT, Topp EM,. 2001. Formaldehyde production by Tris buffer in peptide formulations at elevated temperature. J Pharm Sci 90 (8): 1198-1203.
148. Gold TB, Smith SL, Digenis GA,. 1996. Studies on the influence of pH and pancreatin on 13C-formaldehyde-induced gelatin cross-links using nuclear magnetic resonance. Pharm Dev Technol 1 (1): 21-26.
149. Sutthirak P, Assavanig A, Dharmsthiti S, Lertsiri S,. 2010. Changes in the stability and kinetic parameters up on glycation of thermostable alpha -amylase from Bacillus subtilis. J Food Biochem. 34 (6): 1157-1171.
150. Flores-Fernandez GM, Pagan M, Almenas M, Sola RJ, Griebenow K,. 2010. Moisture-induced solid state instabilities in alpha-chymotrypsin and their reduction through chemical glycosylation. BMC Biotechnol 10: 57.
151. Rondeau P, Navarra G, Cacciabaudo F, Leone M, Bourdon E, Militello V,. 2010. Thermal aggregation of glycated bovine serum albumin. Biochim Biophys Acta 1804 (4): 789-798.
152. Yamabe S, Guan W, Sakaki S,. 2013. Three competitive transition states at the glycosidic bond of sucrose in its acid-catalyzed hydrolysis. J Org Chem 78 (6): 2527-2533.
153. Goldberg RN, Tewari YB, Ahluwalia JC,. 1989. Thermodynamics of the hydrolysis of sucrose. J Biol Chem 264 (17): 9901-9904.
154. Banks DD, Hambly DM, Scavezze JL, Siska CC, Stackhouse NL, Gadgil HS,. 2009. The effect of sucrose hydrolysis on the stability of protein therapeutics during accelerated formulation studies. J Pharm Sci 98 (12): 4501-4510.
155. Dubost DC, Kaufman MJ, Zimmerman JA, Bogusky MJ, Coddington AB, Pitzenberger SM,. 1996. Characterization of a solid state reaction product from a lyophilized formulation of a cyclic heptapeptide. A novel example of an excipient-induced oxidation. Pharm Res 13 (12): 1811-1814.
156. Mueller R, Karle A, Vogt A, Kropshofer H, Ross A, Maeder K, Mahler HC,. 2009. Evaluation of the immuno-stimulatory potential of stopper extractables and leachables by using dendritic cells as readout. J Pharm Sci 98 (10): 3548-3561.
157. Nedich RL,. 1983. Selection of containers and closure systems for injectable products. Am J Hosp Pharm 40 (11): 1924-1927.
158. Lubiniecki A, Volkin DB, Federici M, Bond MD, Nedved ML, Hendricks L, Mehndiratta P, Bruner M, Burman S, Dalmonte P, Kline J, Ni A, Panek ME, Pikounis B, Powers G, Vafa O, Siegel R,. 2011. Comparability assessments of process and product changes made during development of two different monoclonal antibodies. Biologicals 39 (1): 9-22.
159. Chantelau E, Berger M, Bohlken B,. 1986. Silicone oil released from disposable insulin syringes. Diabetes Care 9 (6): 672-673.
160. Bernstein RK,. 1987. Clouding and deactivation of clear (regular) human insulin: Association with silicone oil from disposable syringes ? Diabetes Care 10 (6): 786-787.
161. Majumdar S, Ford BM, Mar KD, Sullivan VJ, Ulrich RG, D'Souza AJM,. 2011. Evaluation of the effect of syringe surfaces on protein formulations. J Pharm Sci 100 (7): 2563-2573.
162. Ludwig DB, Trotter JT, Gabrielson JP, Carpenter JF, Randolph TW,. 2011. Flow cytometry: A promising technique for the study of silicone oil-induced particulate formation in protein formulations. Anal Biochem 410 (2): 191-199.
163. Britt KA, Schwartz DK, Wurth C, Mahler HC, Carpenter JF, Randolph TW,. 2012. Excipient effects on humanized monoclonal antibody interactions with silicone oil emulsions. J Pharm Sci 101 (12): 4419-4432.
164. Thirumangalathu R, Krishnan S, Ricci MS, Brems DN, Randolph TW, Carpenter JF,. 2009. Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. J Pharm Sci 98 (9): 3167-3181.
165. Li JJ, Pinnamaneni S, Quan Y, Jaiswal A, Andersson FI, Zhang XC,. 2012. Mechanistic understanding of protein-silicone oil interactions. Pharm Res 29 (6): 1689-1697.
166. Jones LS, Kaufmann A, Middaugh CR,. 2005. Silicone oil induced aggregation of proteins. J Pharm Sci 94 (4): 918-927.
167. Auge KB, Blake-Haskins AW, Devine S, Rizvi S, Li Y-M, Hesselberg M, Orvisky E, Affleck RP, Spitznagel TM, Perkins MD,. 2011. Demonstrating the
168. Badkar A, Wolf A, Bohack L, Kolhe P,. 2011. Development of biotechnology products in pre-filled syringes: Technical considerations and approaches. AAPS PharmSciTech 12 (2): 564-572.
169. Ludwig DB, Carpenter JF, Hamel J-B, Randolph TW,. 2010. Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. J Pharm Sci 99 (4): 1721-1733.
170. Dixit N, Maloney KM, Kalonia DS,. 2013. Protein-silicone oil interactions: Comparative effect of nonionic surfactants on the interfacial behavior of a fusion protein. Pharm Res 30 (7): 1848-1859.
171. Wakankar AA, Wang YJ, Canova-Davis E, Ma S, Schmalzing D, Grieco J, Milby T, Reynolds T, Mazzarella K, Hoff E, Gomez S, Martin-Moe S,. 2010. On developing a process for conducting extractable-leachable assessment of components used for storage of biopharmaceuticals. J Pharm Sci 99 (5): 2209-2218.
172. Markovic I,. 2007. Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: A risk-based perspective. Expert Opin Drug Saf 6 (5): 487-491.
173. Jenke D,. 2007. Evaluation of the chemical compatibility of plastic contact materials and pharmaceutical products; safety considerations related to extractables and leachables. J Pharm Sci 96 (10): 2566-2581.
174. Pang J, Blanc T, Brown J, Labrenz S, Villalobos A, Depaolis A, Gunturi S, Grossman S, Lisi P, Heavner GA,. 2007. Recognition and identification of UV-absorbing leachables in EPREX pre-filled syringes: An unexpected occurrence at a formulation-component interface. PDA J Pharm Sci Technol 61 (6): 423-432.
175. Liu W, Swift R, Torraca G, Nashed-Samuel Y, Wen ZQ, Jiang Y, Vance A, Mire-Sluis A, Freund E, Davis J, Narhi L,. 2010. Root cause analysis of tungsten-induced protein aggregation in pre-filled syringes. PDA J Pharm Sci Technol 64 (1): 11-19.
176. Mensch CD, Davis HB,. 2012. Inhibition of tungsten-induced protein aggregation by cetyl trimethyl ammonium bromide. PDA J Pharm Sci Technol 66 (1): 2-11.
177. Bee JS, Nelson SA, Freund E, Carpenter JF, Randolph TW,. 2009. Precipitation of a monoclonal antibody by soluble tungsten. J Pharm Sci 98 (9): 3290-3301.
178. Sugio T, Kuwano H, Hamago Y, Negishi A, Maeda T, Takeuchi F, Kamimura K,. 2004. Existence of a tungsten-binding protein in Acidithiobacillus ferrooxidans AP19-3. J Biosci Bioeng 97 (6): 378-382.
179. Ogawa T, Miyajima M, Wakiyama N, Katsuhide T,. 2013. Effects of phosphate buffer in parenteral drugs on particle formation from glass vials. Chem Pharm Bull 61 (5): 539-545.
180. Aoyama T, Horioka M,. 1987. Barium sulfate crystals in parenteral solutions of aminoglycoside antibiotics. Chem Pharm Bull (Tokyo) 35 (3): 1223-1227.
181. Kucko NW, Keenan T, Coughlan A, Hall MM,. 2013. Fill volume as an indicator of surface heterogeneity in glass vials for parenteral packaging. J Pharm Sci 102 (6): 1690-1695.
182. Solomun L, Ibric S, Boltic Z, Djuric Z, Stupar B,. 2008. The impact of primary packaging on the quality of parenteral products. J Pharm Biomed Anal 48 (3): 744-748.
183. Corredor C, Tomasella FP, Young J,. 2009. Drug interactions with potential rubber closure extractables. Identification of thiol-disulfide exchange reaction products of captopril and thiurams. J Chromatogr A 1216 (1): 43-48.
184. Story DA, Leeder J, Cullis P, Bellomo R,. 2005. Biologically active contaminants of intravenous saline in PVC packaging: Australasian, European, and North American samples. Anaesth Intensive Care 33 (1): 78-81.
185. Miyamoto M, Sasakawa S,. 1988. Effects of autoclave sterilization on the physical properties of storage bags and granulocyte function. Vox Sang 54 (2): 74-77.
186. Chang JY, Xiao NJ, Zhu M, Zhang J, Hoff E, Russell SJ, Katta V, Shire SJ,. 2010. Leachables from saline-containing IV bags can alter therapeutic protein properties. Pharm Res 27 (11): 2402-2413.
187. Reynolds G, Paskiet D,. 2011. Glass delamination and breakage-New answers for a growing problem. Bio Process Int 9 (11): 52-57.
188. Ennis RD, Pritchard R, Nakamura C, Coulon M, Yang T, Visor GC, Lee WA,. 2001. Glass vials for small volume parenterals: Influence of drug and manufacturing processes on glass delamination. Pharm Dev Technol 6 (3): 393-405.
189. Guadagnino E, Zuccato D,. 2012. Delamination propensity of pharmaceutical glass containers by accelerated testing with different extraction media. PDA J Pharm Sci Technol 66 (2): 116-125.
190. Wen ZQ, Torraca G, Masatani P, Sloey C, Phillips J,. 2012. Nondestructive detection of glass vial inner surface morphology with differential interference contrast microscopy. J Pharm Sci 101 (4): 1378-1384.
191. Ratnaswamy G, Hair A, Li G, Thirumangalathu R, Nashed-Samuel Y, Brych L, Dharmavaram V, Wen ZQ, Fujimori K, Jing W, Sethuraman A, Swift R, Ricci MS, Piedmonte DM,. 2014. A case study of nondelamination glass dissolution resulting in visible particles: Implications for neutral pH formulations. J Pharm Sci Feb 4. doi: 10.1002/jps.23871.
192. Sacha GA, Saffell-Clemmer W, Abram K, Akers MJ,. 2010. Practical fundamentals of glass, rubber, and plastic sterile packaging systems. Pharm Dev Technol 15 (1): 6-34.
193. Chi EY, Weickmann J, Carpenter JF, Manning MC, Randolph TW,. 2005. Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation. J Pharm Sci 94 (2): 256-274.
194. Ji JA, Borisov O, Ingham E, Ling V, Wang YJ,. 2009. Compatibility of a protein topical gel with wound dressings. J Pharm Sci 98 (2): 595-605.
195. Rothen-Weinhold A, Oudry N, Schwach-Abdellaoui K, Frutiger-Hughes S, Hughes GJ, Jeannerat D, Burger U, Besseghir K, Gurny R,. 2000. Formation of peptide impurities in polyester matrices during implant manufacturing. Eur J Pharm Biopharm 49 (3): 253-257.
196. Mader K, Domb A, Swartz HM,. 1996. Gamma-sterilization-induced radicals in biodegradable drug delivery systems. Appl Radiat Isot 47 (11-12): 1669-1674.
197. Karogodina TY, Sergeeva SV, Stass DV,. 2011. Stability and reactivity of free radicals: A physicochemical perspective with biological implications. Hemoglobin 35 (3): 262-275.
198. Wang W,. 2000. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm 203 (1-2): 1-60.
199. Held HR, Landi S,. 1977. Water permeability of elastomers. J Biol Standard 5 (2): 111-119.
200. Chen Y, Li Y,. 2003. A new model for predicting moisture uptake by packaged solid pharmaceuticals. Int J Pharm 255 (1-2): 217-225.
201. Pohloudek-Fabini R, Martin E,. 1981. The effect of the gas permeability of plastics on the stability of thiomersal. Part 49: Contributions to problems concerning the use of plastic receptacles for liquid pharmaceuticals (author's transl). Pharmazie 36 (10): 683-685.
202. van Willige RW, Linssen JP, Meinders MB, van der Stege HJ, Voragen AG,. 2002. Influence of flavour absorption on oxygen permeation through LDPE, PP, PC and PET plastics food packaging. Food Addit Contam 19 (3): 303-313.
203. Doge G, Dittgen M, Garbe S,. 1985. The storage capability of pre-filled disposable plastic syringes. Pharmazie 40 (8): 559-561.
204. Zuleger B, Werner U, Kort A, Glowienka R, Wehnes E, Duncan D,. 2012. Container/closure integrity testing and the identification of a suitable vial/stopper combination for low-temperature storage at -80°C. PDA J Pharm Sci Technol 66 (5): 453-465.
205. Kerkaert B, Mestdagh F, Cucu T, Aedo PR, Ling SY, De Meulenaer B,. 2011. Hypochlorous and peracetic acid induced oxidation of dairy proteins. J Agric Food Chem 59 (3): 907-914.
206. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B,. 2009. Overlooking subvisible particles in therapeutic protein products: Gaps that may compromise product quality. J Pharm Sci 98 (4): 1201-1205.
207. Singh SK, Afonina N, Awwad M, Bechtold-Peters K, Blue JT, Chou D, Cromwell M, Krause H-J, Mahler H-C, Meyer BK, Narhi L, Nesta DP, Spitznagel T,. 2010. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J Pharm Sci 99 (8): 3302-3321.
208. Doessegger L, Mahler HC, Szczesny P, Rockstroh H, Kallmeyer G, Langenkamp A, Herrmann J, Famulare J,. 2012. The potential clinical relevance of visible particles in parenteral drugs. J Pharm Sci 101 (8): 2635-2644.
209. de Abreu CS, Pinto Tde J, de Oliveira DC,. 2004. Environmental monitoring: A correlation study between viable and nonviable particles in clean rooms. PDA J Pharm Sci Technol 58 (1): 45-53.
210. Liu L, Randolph TW, Carpenter JF,. 2012. Particles shed from syringe filters and their effects on agitation-induced protein aggregation. J Pharm Sci 101 (8): 2952-2959.
211. Tyagi AK, Randolph TW, Dong A, Maloney KM, Hitscherich C, Jr, Carpenter JF,. 2009. IgG particle formation during filling pump operation: A case study of heterogeneous nucleation on stainless steel nanoparticles. J Pharm Sci 98 (1): 94-104.
212. Jenke DR, Story J, Lalani R,. 2006. Extractables/leachables from plastic tubing used in product manufacturing. Int J Pharm 315 (1-2): 75-92.
213. Qi P, Volkin DB, Zhao H, Nedved ML, Hughes R, Bass R, Yi SC, Panek ME, Wang D, Dalmonte P, Bond MD,. 2008. Characterization of the photodegradation of a human IgG1 monoclonal antibody formulated as a high-concentration liquid dosage form. J Pharm Sci 98 (9): 3117-3130.
214. Kerwin BA, Remmele RL, Jr,. 2007. Protect from light: Photodegradation and protein biologics. J Pharm Sci 96 (6): 1468-1479.
215. Mason BD, Schoneich C, Kerwin BA,. 2012. Effect of pH and light on aggregation and conformation of an IgG1 mAB. Mol Pharm 9 (4): 774-790.
216. Vanhooren A, Devreese B, Vanhee K, Van Beeumen J, Hanssens I,. 2002. Photoexcitation of tryptophan groups induces reduction of two disulfide bonds in goat alpha-lactalbumin. Biochemistry (Mosc) 41 (36): 11035-11043.
217. Davies MJ,. 2003. Singlet oxygen-mediated damage to proteins and its consequences. Biochem Biophys Res Commun 305 (3): 761-770.
218. Li DY, Borkman RF, Wang RH, Dillon J,. 1990. Mechanisms of photochemically produced turbidity in lens protein solutions. Exp Eye Res 51 (6): 663-669.
219. Skidmore K, Hewitt D, Kao YH,. 2012. Quantitation and characterization of process impurities and extractables in protein-containing solutions using proton NMR as a general tool. Biotechnol Prog 28 (6): 1526-1533.
220. Schenauer MR, Flynn GC, Goetze AM,. 2012. Identification and quantification of host cell protein impurities in biotherapeutics using mass spectrometry. Anal Biochem 428 (2): 150-157.
221. Xie H, Gilar M, Gebler JC,. 2009. Characterization of protein impurities and site-specific modifications using peptide mapping with liquid chromatography and data independent acquisition mass spectrometry. Anal Chem 81 (14): 5699-5708.
222. Brezar V, Culina S, Osterbye T, Guillonneau F, Chiappetta G, Verdier Y, Vinh J, Wong FS, Buus S, Mallone R,. 2011. T cells recognizing a peptide contaminant undetectable by mass spectrometry. PLoS ONE 6 (12): e28866.