-
1
-
-
45149128290
-
Current perspectives on stability of protein drug products during formulation, fill and finish operations
-
N. Rathore, and R.S. Rajan Current perspectives on stability of protein drug products during formulation, fill and finish operations Biotechnol. Prog. 24 3 2008 504 514
-
(2008)
Biotechnol. Prog.
, vol.24
, Issue.3
, pp. 504-514
-
-
Rathore, N.1
Rajan, R.S.2
-
3
-
-
34250781639
-
Protect from light: Photodegradation and protein biologics
-
B.A. Kerwin, and R.L. Remmele Jr. Protect from light: photodegradation and protein biologics J. Pharm. Sci. 96 6 2007 1468 1479
-
(2007)
J. Pharm. Sci.
, vol.96
, Issue.6
, pp. 1468-1479
-
-
Kerwin, B.A.1
Remmele, R.L.2
-
4
-
-
0036363722
-
Calcium-Binding Protein Protocols
-
Humana Press
-
S.M. Martin, P.M. Bayley, Calcium-Binding Protein Protocols, Methods in Mol Biol, Humana Press 173 (2002) 43-55.
-
(2002)
Methods in Mol Biol
, vol.173
, pp. 43-55
-
-
Martin, S.M.1
Bayley, P.M.2
-
6
-
-
31544465918
-
Immunoglobulins can utilize riboflavin (Vitamin B2) to activate the antibody-catalyzed water oxidation pathway
-
J. Nieva, L. Kerwin, A.D. Wentworth, R.A. Lerner, and P. Wentworth Jr. Immunoglobulins can utilize riboflavin (Vitamin B2) to activate the antibody-catalyzed water oxidation pathway Immunol. Lett. 103 1 2006 33 38
-
(2006)
Immunol. Lett.
, vol.103
, Issue.1
, pp. 33-38
-
-
Nieva, J.1
Kerwin, L.2
Wentworth, A.D.3
Lerner, R.A.4
Wentworth, P.5
-
7
-
-
0034105326
-
Reactivity of monoclonal antibodies against a tryptophan-riboflavin adduct toward irradiated and non-irradiated bovine-eye-lens protein fractions: An indicator of in vivo visible-light-mediated phototransformations
-
M. Mancini, A.M. Edwards, M.I. Becker, A. de Ioannes, and E. Silva Reactivity of monoclonal antibodies against a tryptophan-riboflavin adduct toward irradiated and non-irradiated bovine-eye-lens protein fractions: an indicator of in vivo visible-light-mediated phototransformations J. Photochem. Photobiol., B 55 1 2000 9 15
-
(2000)
J. Photochem. Photobiol., B
, vol.55
, Issue.1
, pp. 9-15
-
-
Mancini, M.1
Edwards, A.M.2
Becker, M.I.3
De Ioannes, A.4
Silva, E.5
-
8
-
-
80054896994
-
Photosensitizers form in histidine buffer and mediate the photodegradation of a monoclonal antibody
-
S.D. Stroop, D.M. Conca, R.P. Lundgard, M.E. Renz, L.M. Peabody, and S.D. Leigh Photosensitizers form in histidine buffer and mediate the photodegradation of a monoclonal antibody J. Pharm. Sci. 100 12 2011 5142 5155
-
(2011)
J. Pharm. Sci.
, vol.100
, Issue.12
, pp. 5142-5155
-
-
Stroop, S.D.1
Conca, D.M.2
Lundgard, R.P.3
Renz, M.E.4
Peabody, L.M.5
Leigh, S.D.6
-
9
-
-
68949107399
-
Characterization of the photodegradation of a human IgG1 monoclonal antibody formulated as a high-concentration liquid dosage form
-
P. Qi, D.B. Volkin, H. Zhao, M.L. Nedved, R. Hughes, R. Bass, S.C. Yi, M.E. Panek, D. Wang, P. Dalmonte, and M.D. Bond Characterization of the photodegradation of a human IgG1 monoclonal antibody formulated as a high-concentration liquid dosage form J. Pharm. Sci. 98 9 2009 3117 3130
-
(2009)
J. Pharm. Sci.
, vol.98
, Issue.9
, pp. 3117-3130
-
-
Qi, P.1
Volkin, D.B.2
Zhao, H.3
Nedved, M.L.4
Hughes, R.5
Bass, R.6
Yi, S.C.7
Panek, M.E.8
Wang, D.9
Dalmonte, P.10
Bond, M.D.11
-
10
-
-
84879714299
-
Photodegradation of human growth hormone: A novel backbone cleavage between Glu-88 and Pro-89
-
D. Steinmann, J.A. Ji, Y.J. Wang, and C. Schoneich Photodegradation of human growth hormone: a novel backbone cleavage between Glu-88 and Pro-89 Mol. Pharm. 10 7 2013 2693 2706
-
(2013)
Mol. Pharm.
, vol.10
, Issue.7
, pp. 2693-2706
-
-
Steinmann, D.1
Ji, J.A.2
Wang, Y.J.3
Schoneich, C.4
-
11
-
-
84874591845
-
Light-induced conversion of Trp to Gly and Gly hydroperoxide in IgG1
-
J. Haywood, O. Mozziconacci, K.M. Allegre, B.A. Kerwin, and C. Schoneich Light-induced conversion of Trp to Gly and Gly hydroperoxide in IgG1 Mol. Pharm. 10 3 2013 1146 1150
-
(2013)
Mol. Pharm.
, vol.10
, Issue.3
, pp. 1146-1150
-
-
Haywood, J.1
Mozziconacci, O.2
Allegre, K.M.3
Kerwin, B.A.4
Schoneich, C.5
-
12
-
-
84901247909
-
Discovery and characterization of a photo-oxidative histidine-histidine cross-link in IgG1 antibody utilizing (1)(8)O-labeling and mass spectrometry
-
M. Liu, Z. Zhang, J. Cheetham, D. Ren, and Z.S. Zhou Discovery and characterization of a photo-oxidative histidine-histidine cross-link in IgG1 antibody utilizing (1)(8)O-labeling and mass spectrometry Anal. Chem. 86 10 2014 4940 4948
-
(2014)
Anal. Chem.
, vol.86
, Issue.10
, pp. 4940-4948
-
-
Liu, M.1
Zhang, Z.2
Cheetham, J.3
Ren, D.4
Zhou, Z.S.5
-
13
-
-
84872140390
-
Role of surface exposed tryptophan as substrate generators for the antibody catalyzed water oxidation pathway
-
A. Sreedhara, K. Lau, C. Li, B. Hosken, F. Macchi, D. Zhan, A. Shen, D. Steinmann, C. Schoneich, and Y. Lentz Role of surface exposed tryptophan as substrate generators for the antibody catalyzed water oxidation pathway Mol. Pharm. 10 1 2013 278 288
-
(2013)
Mol. Pharm.
, vol.10
, Issue.1
, pp. 278-288
-
-
Sreedhara, A.1
Lau, K.2
Li, C.3
Hosken, B.4
Macchi, F.5
Zhan, D.6
Shen, A.7
Steinmann, D.8
Schoneich, C.9
Lentz, Y.10
-
14
-
-
2342617587
-
The antibody-catalyzed water oxidation pathway - A new chemical arm to immune defense?
-
J. Nieva, and P. Wentworth Jr. The antibody-catalyzed water oxidation pathway - a new chemical arm to immune defense? Trends Biochem. Sci. 29 5 2004 274 278
-
(2004)
Trends Biochem. Sci.
, vol.29
, Issue.5
, pp. 274-278
-
-
Nieva, J.1
Wentworth, P.2
-
15
-
-
84922949925
-
Effect of ambient light on monoclonal antibody product quality during small-scale mammalian cell culture process in clear glass bioreactors
-
M. Mallaney, S.H. Wang, and A. Sreedhara Effect of ambient light on monoclonal antibody product quality during small-scale mammalian cell culture process in clear glass bioreactors Biotechnol. Prog. 30 3 2014 562 570
-
(2014)
Biotechnol. Prog.
, vol.30
, Issue.3
, pp. 562-570
-
-
Mallaney, M.1
Wang, S.H.2
Sreedhara, A.3
-
16
-
-
84897992917
-
Screening methods to identify indole derivatives that protect against reactive oxygen species induced tryptophan oxidation in proteins
-
P. Grewal, M. Mallaney, K. Lau, and A. Sreedhara Screening methods to identify indole derivatives that protect against reactive oxygen species induced tryptophan oxidation in proteins Mol. Pharm. 11 4 2014 1259 1272
-
(2014)
Mol. Pharm.
, vol.11
, Issue.4
, pp. 1259-1272
-
-
Grewal, P.1
Mallaney, M.2
Lau, K.3
Sreedhara, A.4
-
17
-
-
84886753050
-
Effect of cell culture medium components on color of formulated monoclonal antibody drug substance
-
N. Vijayasankaran, S. Varma, Y. Yang, M. Mun, S. Arevalo, M. Gawlitzek, T. Swartz, A. Lim, F. Li, B. Zhang, S. Meier, and R. Kiss Effect of cell culture medium components on color of formulated monoclonal antibody drug substance Biotechnol. Prog. 29 5 2013 1270 1277
-
(2013)
Biotechnol. Prog.
, vol.29
, Issue.5
, pp. 1270-1277
-
-
Vijayasankaran, N.1
Varma, S.2
Yang, Y.3
Mun, M.4
Arevalo, S.5
Gawlitzek, M.6
Swartz, T.7
Lim, A.8
Li, F.9
Zhang, B.10
Meier, S.11
Kiss, R.12
-
18
-
-
84889871265
-
Hydroxocobalamin association during cell culture results in pink therapeutic proteins
-
K.M. Prentice, R. Gillespie, N. Lewis, K. Fujimori, R. McCoy, J. Bach, L. Connell-Crowley, and C.M. Eakin Hydroxocobalamin association during cell culture results in pink therapeutic proteins mAbs 5 6 2013 974 981
-
(2013)
mAbs
, vol.5
, Issue.6
, pp. 974-981
-
-
Prentice, K.M.1
Gillespie, R.2
Lewis, N.3
Fujimori, K.4
McCoy, R.5
Bach, J.6
Connell-Crowley, L.7
Eakin, C.M.8
-
19
-
-
84899768673
-
Red colored IgG4 caused by vitamin B12 from cell culture media combined with disulfide reduction at harvest
-
G.E. Derfus, J. Dizon-Maspat, J.T. Broddrick, A.C. Velayo, J.D. Toschi, R.T. Santuray, S.K. Hsu, C.M. Winter, R. Krishnan, and A. Amanullah Red colored IgG4 caused by vitamin B12 from cell culture media combined with disulfide reduction at harvest mAbs 6 3 2014 679 688
-
(2014)
mAbs
, vol.6
, Issue.3
, pp. 679-688
-
-
Derfus, G.E.1
Dizon-Maspat, J.2
Broddrick, J.T.3
Velayo, A.C.4
Toschi, J.D.5
Santuray, R.T.6
Hsu, S.K.7
Winter, C.M.8
Krishnan, R.9
Amanullah, A.10
-
20
-
-
84907921130
-
Recombinant antibody color resulting from advanced glycation end product modifications
-
M. Butko, H. Pallat, A. Cordoba, and X.C. Yu Recombinant antibody color resulting from advanced glycation end product modifications Anal. Chem. 86 19 2014 9816 9823
-
(2014)
Anal. Chem.
, vol.86
, Issue.19
, pp. 9816-9823
-
-
Butko, M.1
Pallat, H.2
Cordoba, A.3
Yu, X.C.4
-
21
-
-
84904357557
-
Characterization of the degradation products of a color-changed monoclonal antibody: Tryptophan-derived chromophores
-
Y. Li, A. Polozova, F. Gruia, and J. Feng Characterization of the degradation products of a color-changed monoclonal antibody: tryptophan-derived chromophores Anal. Chem. 86 14 2014 6850 6857
-
(2014)
Anal. Chem.
, vol.86
, Issue.14
, pp. 6850-6857
-
-
Li, Y.1
Polozova, A.2
Gruia, F.3
Feng, J.4
-
22
-
-
84859313113
-
Effect of pH and light on aggregation and conformation of an IgG1 mAb
-
B.D. Mason, C. Schoneich, and B.A. Kerwin Effect of pH and light on aggregation and conformation of an IgG1 mAb Mol. Pharm. 9 4 2012 774 790
-
(2012)
Mol. Pharm.
, vol.9
, Issue.4
, pp. 774-790
-
-
Mason, B.D.1
Schoneich, C.2
Kerwin, B.A.3
-
23
-
-
84885862998
-
Implications of in-use photostability: Proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: Drug products administered by injection
-
S.W. Baertschi, D. Clapham, C. Foti, P.J. Jansen, S. Kristensen, R.A. Reed, A.C. Templeton, and H.H. Tonnesen Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: drug products administered by injection J. Pharm. Sci. 102 11 2013 3888 3899
-
(2013)
J. Pharm. Sci.
, vol.102
, Issue.11
, pp. 3888-3899
-
-
Baertschi, S.W.1
Clapham, D.2
Foti, C.3
Jansen, P.J.4
Kristensen, S.5
Reed, R.A.6
Templeton, A.C.7
Tonnesen, H.H.8
-
24
-
-
73649143500
-
Effects of arginine on photostability and thermal stability of IgG1 monoclonal antibodies
-
H. Maity, C. O'Dell, A. Srivastava, and J. Goldstein Effects of arginine on photostability and thermal stability of IgG1 monoclonal antibodies Curr. Pharm. Biotechnol. 10 8 2009 761 766
-
(2009)
Curr. Pharm. Biotechnol.
, vol.10
, Issue.8
, pp. 761-766
-
-
Maity, H.1
O'Dell, C.2
Srivastava, A.3
Goldstein, J.4
-
25
-
-
80054773616
-
Site-specific tryptophan oxidation induced by autocatalytic reaction of polysorbate 20 in protein formulation
-
X.M. Lam, W.G. Lai, E.K. Chan, V. Ling, and C.C. Hsu Site-specific tryptophan oxidation induced by autocatalytic reaction of polysorbate 20 in protein formulation Pharm. Res. 28 10 2011 2543 2555
-
(2011)
Pharm. Res.
, vol.28
, Issue.10
, pp. 2543-2555
-
-
Lam, X.M.1
Lai, W.G.2
Chan, E.K.3
Ling, V.4
Hsu, C.C.5
-
26
-
-
2642550862
-
Challenges in the development of high protein concentration formulations
-
S.J. Shire, Z. Shahrokh, and J. Liu Challenges in the development of high protein concentration formulations J. Pharm. Sci. 93 6 2004 1390 1402
-
(2004)
J. Pharm. Sci.
, vol.93
, Issue.6
, pp. 1390-1402
-
-
Shire, S.J.1
Shahrokh, Z.2
Liu, J.3
-
27
-
-
84955587189
-
-
Wiley (Ed.), third ed., Hoboken, NJ
-
R.S. Berns, Billmeyer and Saltzman's Principles of Color Technology, in: Wiley (Ed.), third ed., Hoboken, NJ, 2000, pp. 50-51.
-
(2000)
Billmeyer and Saltzman's Principles of Color Technology
, pp. 50-51
-
-
Berns, R.S.1
-
28
-
-
84862845539
-
Effect of polysorbate 80 quality on photostability of a monoclonal antibody
-
S.R. Singh, J. Zhang, C. O'Dell, M.C. Hsieh, J. Goldstein, J. Liu, and A. Srivastava Effect of polysorbate 80 quality on photostability of a monoclonal antibody AAPS PharmSciTech 13 2 2012 422 430
-
(2012)
AAPS PharmSciTech
, vol.13
, Issue.2
, pp. 422-430
-
-
Singh, S.R.1
Zhang, J.2
O'Dell, C.3
Hsieh, M.C.4
Goldstein, J.5
Liu, J.6
Srivastava, A.7
-
29
-
-
0030724407
-
Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody HER2
-
X.M. Lam, J.Y. Yang, and J.L. Cleland Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody HER2 J. Pharm. Sci. 86 11 1997 1250 1255
-
(1997)
J. Pharm. Sci.
, vol.86
, Issue.11
, pp. 1250-1255
-
-
Lam, X.M.1
Yang, J.Y.2
Cleland, J.L.3
-
30
-
-
77953302861
-
A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revision
-
S.W. Baertschi, K.M. Alsante, and H.H. Tonnesen A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): recommendation for revision J. Pharm. Sci. 99 7 2010 2934 2940
-
(2010)
J. Pharm. Sci.
, vol.99
, Issue.7
, pp. 2934-2940
-
-
Baertschi, S.W.1
Alsante, K.M.2
Tonnesen, H.H.3
|