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Volumn 100, Issue , 2016, Pages 38-46

Effect of ambient light on IgG1 monoclonal antibodies during drug product processing and development

Author keywords

Ambient light; Drug product processing; HunterLab; Mild light; Photodegradation; Photooxidation; Photostability; Relevant stress

Indexed keywords

IMMUNOGLOBULIN G1 ANTIBODY; MONOCLONAL ANTIBODY; TRYPTOPHAN; IMMUNOGLOBULIN G;

EID: 84955583891     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2015.12.003     Document Type: Article
Times cited : (73)

References (30)
  • 1
    • 45149128290 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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
  • 12
    • 84901247909 scopus 로고    scopus 로고
    • 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
  • 14
    • 2342617587 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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
  • 20
    • 84907921130 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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
  • 29
    • 0030724407 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.