-
1
-
-
79952470342
-
Comparability of biopharmaceutical glycosylation during scale-up
-
Jan
-
Fernandes, D.L. (2011) Comparability of biopharmaceutical glycosylation during scale-up. Biopharm. Int., Jan, 45-53.
-
(2011)
Biopharm. Int.
, pp. 45-53
-
-
Fernandes, D.L.1
-
2
-
-
84884658152
-
-
International Conference on Harminization, ICH Q6B: Specifi cations: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products. EMA Document CPMP/ICH/365/96. ICH Geneva.
-
International Conference on Harminization (1999) ICH Q6B: Specifi cations: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products. EMA Document CPMP/ICH/365/96. ICH, Geneva.
-
(1999)
-
-
-
3
-
-
84884661518
-
-
International Conference on Harminization, ICH Q5E: Comparability of Biotechnological/ Biological Products Subject to Changes in their Manufacturing Process. EMA Document CPMP/ICH/5721/03. ICH Geneva.
-
International Conference on Harminization (2003) ICH Q5E: Comparability of Biotechnological/ Biological Products Subject to Changes in their Manufacturing Process. EMA Document CPMP/ICH/5721/03. ICH, Geneva.
-
(2003)
-
-
-
4
-
-
84884617911
-
-
European Medicines Agency, ICH Q8(R2): Pharmaceutical Development. EMA Document CHMP/ICH/167068/04. EMEA London.
-
European Medicines Agency (2009) ICH Q8(R2): Pharmaceutical Development. EMA Document CHMP/ICH/167068/04. EMEA, London.
-
(2009)
-
-
-
5
-
-
84884627459
-
-
European Medicines Agency, ICH Q8/Q9/Q10: Implementation. EMA Document EMA/CHMP/ICH/265145/2009. EMEA, London.
-
European Medicines Agency (2010) ICH Q8/Q9/Q10: Implementation. EMA Document EMA/CHMP/ICH/265145/2009. EMEA, London.
-
(2010)
-
-
-
6
-
-
68749083515
-
Roadmap for implementation of quality by design (QbD) for biotechnology products
-
Rathore, A.S. (2009) Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol., 27, 546-553.
-
(2009)
Trends Biotechnol.
, vol.27
, pp. 546-553
-
-
Rathore, A.S.1
-
7
-
-
84884644225
-
-
European Medicines Agency, EMEA Guideline on Development Production Characterisation and Specifi cations for Monoclonal Antibodies and Related Products. EMEA/CHMP/ BWP/157653/2007. EMEA London.
-
European Medicines Agency (2007) EMEA Guideline on Development, Production, Characterisation and Specifi cations for Monoclonal Antibodies and Related Products. EMEA/CHMP/ BWP/157653/2007. EMEA, London.
-
(2007)
-
-
-
8
-
-
79952534748
-
Taking immunogenicity assessment of therapeutic proteins to the next level
-
Büttel, I.C., Chamberlain, P., Chowers, Y., Ehmann, F., Greinacher, A., Jefferis, R., Kramer, D., Kropshofer, H., Lloyd, P., Lubiniecki, A., Krause, R., Mire-Sluis, A., Platts-Mills, T., Ragheb, J.A., Reipert, B.M., Schellekens, H., Seitz, R., Stas, P., Subramanyam, M., Thorpe, R., Trouvin, J.H., Weise, M., Windisch, J., and Schneider, C.K. (2011) Taking immunogenicity assessment of therapeutic proteins to the next level. Biologicals, 39, 100-109.
-
(2011)
Biologicals
, vol.39
, pp. 100-109
-
-
Büttel, I.C.1
Chamberlain, P.2
Chowers, Y.3
Ehmann, F.4
Greinacher, A.5
Jefferis, R.6
Kramer, D.7
Kropshofer, H.8
Lloyd, P.9
Lubiniecki, A.10
Krause, R.11
Mire-Sluis, A.12
Platts-Mills, T.13
Ragheb, J.A.14
Reipert, B.M.15
Schellekens, H.16
Seitz, R.17
Stas, P.18
Subramanyam, M.19
Thorpe, R.20
Trouvin, J.H.21
Weise, M.22
Windisch, J.23
Schneider, C.K.24
more..
-
9
-
-
84884612946
-
-
Implementing quality by design. PDA/FDA Joint Regulatory Conference-Evolution of the Global Regulatory Environment: A Practical Approach to Change Washington DC.
-
Winkle, H.N. (2007) Implementing quality by design. PDA/FDA Joint Regulatory Conference-Evolution of the Global Regulatory Environment: A Practical Approach to Change, Washington, DC.
-
(2007)
-
-
Winkle, H.N.1
-
10
-
-
46749139421
-
Biochemical and pharmacological characterization of different recombinant acid alpha-glucosidase preparations evaluated for the treatment of Pompe disease
-
McVie-Wylie, A.J., Lee, K.L., Qiu, H., Jin, X., Do, H., Gotschall, R., Thurberg, B.L., Rogers, C., Raben, N., O'Callaghan, M., Canfield, W., Andrews, L., McPherson, J.M., and Mattaliano, R.J. (2008) Biochemical and pharmacological characterization of different recombinant acid alpha-glucosidase preparations evaluated for the treatment of Pompe disease. Mol. Genet. Metab., 94, 448-455.
-
(2008)
Mol. Genet. Metab.
, vol.94
, pp. 448-455
-
-
McVie-Wylie, A.J.1
Lee, K.L.2
Qiu, H.3
Jin, X.4
Do, H.5
Gotschall, R.6
Thurberg, B.L.7
Rogers, C.8
Raben, N.9
O'Callaghan, M.10
Canfield, W.11
Andrews, L.12
McPherson, J.M.13
Mattaliano, R.J.14
-
11
-
-
67349219428
-
Glycoengineered acid alpha-glucosidase with improved effi cacy at correcting the metabolic aberrations and motor function defi cits in a mouse model of Pompe disease
-
Zhu, Y., Jiang, J.L., Gumlaw, N.K., Zhang, J., Bercury, S.D., Ziegler, R.J., Lee, K., Kudo, M., Canfield, W.M., Edmunds, T., Jiang, C., Mattaliano, R.J., and Cheng, S.H. (2009) Glycoengineered acid alpha-glucosidase with improved effi cacy at correcting the metabolic aberrations and motor function defi cits in a mouse model of Pompe disease. Mol. Ther., 17, 954-963.
-
(2009)
Mol. Ther.
, vol.17
, pp. 954-963
-
-
Zhu, Y.1
Jiang, J.L.2
Gumlaw, N.K.3
Zhang, J.4
Bercury, S.D.5
Ziegler, R.J.6
Lee, K.7
Kudo, M.8
Canfield, W.M.9
Edmunds, T.10
Jiang, C.11
Mattaliano, R.J.12
Cheng, S.H.13
-
12
-
-
77953364987
-
Quality by design; the next phase-potential regulatory implications and fi ling of QbD data
-
Mire-Sluis, A., Schenerman, M., Mhatre, R., Advant, S., Dougherty, J., Kozlowski, S., Nashbeh, W., and McLeod, L.D. (2009) Quality by design; the next phase-potential regulatory implications and fi ling of QbD data. BioProcess Int., 2009, 34-42.
-
(2009)
BioProcess Int.
, vol.2009
, pp. 34-42
-
-
Mire-Sluis, A.1
Schenerman, M.2
Mhatre, R.3
Advant, S.4
Dougherty, J.5
Kozlowski, S.6
Nashbeh, W.7
McLeod, L.D.8
-
13
-
-
84891563176
-
-
http://www.casss.org/associations/9165/files/A-MAb_Case_Study_Version_2-1.pdf
-
-
-
-
14
-
-
84884612932
-
-
Implementing QbD: a process scientist's perspective. Bioprocess International Conference Nice.
-
Bannerjee, A. (2011) Implementing QbD: a process scientist's perspective. Bioprocess International Conference, Nice.
-
(2011)
-
-
Bannerjee, A.1
-
15
-
-
84884620045
-
-
Quality by Design and its practical application. Seminar in Quality by Design short course San Diego April 2010 organized by Cambridge Healthtech Institute.
-
Taticek, R. (2010) Quality by Design and its practical application. Seminar in Quality by Design short course, San Diego, April 2010, organized by Cambridge Healthtech Institute.
-
(2010)
-
-
Taticek, R.1
-
16
-
-
84884617833
-
-
John Berridge: How to handle A-Mab, and aspirational and inspirational document. Pharma QbD Expert Insights
-
Berridge, J. (2010) John Berridge: How to handle A-Mab, and aspirational and inspirational document. Pharma QbD Expert Insights. http://www.pharmaqbd.com/johnberridge_amab/
-
(2010)
-
-
Berridge, J.1
-
17
-
-
0029888035
-
The hypothetical N-glycan charge: a number that characterizes protein glycosylation
-
Hermentin, P., Witzel, R., Kanzy, E.J., Diderrich, G., Hoffmann, D., Metzner, H., Vorlop, J., and Haupt, H. (1996) The hypothetical N-glycan charge: a number that characterizes protein glycosylation. Glycobiology, 6, 217-230.
-
(1996)
Glycobiology
, vol.6
, pp. 217-230
-
-
Hermentin, P.1
Witzel, R.2
Kanzy, E.J.3
Diderrich, G.4
Hoffmann, D.5
Metzner, H.6
Vorlop, J.7
Haupt, H.8
-
18
-
-
55249121695
-
Antibody fucosylation differentially impacts cytotoxicity mediated by NK and PMN effector cells
-
Peipp, M., Lammerts van Bueren, J.J., Schneider-Merck, T., Bleeker, W.W.K., Dechant, M., Beyer, T., Repp, R., van Berkel, P.H.C., Vink, T., van de Winkel, J.G.J., Parren, P.W.H.I., and Valerius, T. (2008) Antibody fucosylation differentially impacts cytotoxicity mediated by NK and PMN effector cells. Blood, 112, 2390-2399.
-
(2008)
Blood
, vol.112
, pp. 2390-2399
-
-
Peipp, M.1
Lammerts van Bueren, J.J.2
Schneider-Merck, T.3
Bleeker, W.W.K.4
Dechant, M.5
Beyer, T.6
Repp, R.7
van Berkel, P.H.C.8
Vink, T.9
van de Winkel, J.G.J.10
Parren, P.W.H.I.11
Valerius, T.12
-
19
-
-
64549099901
-
N-linked glycosylation is an important parameter for optimal selection of cell lines producing biopharmaceutical human IgG
-
van Berkel, P.H., Gerritsen, J., Perdok, G., Valbjørn, J., Vink, T., van de Winkel, J.G., and Parren, P.W. (2009) N-linked glycosylation is an important parameter for optimal selection of cell lines producing biopharmaceutical human IgG. Biotechnol. Prog., 25, 244-251.
-
(2009)
Biotechnol. Prog.
, vol.25
, pp. 244-251
-
-
van Berkel, P.H.1
Gerritsen, J.2
Perdok, G.3
Valbjørn, J.4
Vink, T.5
van de Winkel, J.G.6
Parren, P.W.7
-
20
-
-
77955412238
-
Post-translational modifi cations differentially affect IgG1 conformation and receptor binding
-
Houde, D., Peng, Y., Berkowitz, S.A., and Engen, J.R. (2010) Post-translational modifi cations differentially affect IgG1 conformation and receptor binding. Mol. Cell Proteomics, 9, 1716-1728.
-
(2010)
Mol. Cell Proteomics
, vol.9
, pp. 1716-1728
-
-
Houde, D.1
Peng, Y.2
Berkowitz, S.A.3
Engen, J.R.4
-
21
-
-
40849142102
-
Cetuximab-induced anaphylaxis and IgE specifi c for galactose-alpha-1, 3-galactose
-
Chung, C.H., Mirakhur, B., Chan, E., Le, Q.T., Berlin, J., Morse, M., Murphy, B.A., Satinover, S.M., Hosen, J., Mauro, D., Slebos, R.J., Zhou, Q., Gold, D., Hatley, T., Hicklin, D.J., and Platts-Mills, T.A. (2008) Cetuximab-induced anaphylaxis and IgE specifi c for galactose-alpha-1, 3-galactose. N. Engl. J. Med., 358, 1109-1117.
-
(2008)
N. Engl. J. Med.
, vol.358
, pp. 1109-1117
-
-
Chung, C.H.1
Mirakhur, B.2
Chan, E.3
Le, Q.T.4
Berlin, J.5
Morse, M.6
Murphy, B.A.7
Satinover, S.M.8
Hosen, J.9
Mauro, D.10
Slebos, R.J.11
Zhou, Q.12
Gold, D.13
Hatley, T.14
Hicklin, D.J.15
Platts-Mills, T.A.16
-
22
-
-
79960215653
-
Anti-galactose-a-1, 3-galactose IgE from allergic patients does not bind a-galactosylated glycans on intact therapeutic antibody Fc domains
-
van Bueren, J.J.L., Rispens, T., Verploegen, S., van der Palen-Merkus, T., Stapel, S., Workman, L.J., James, H., van Berkel, P.H.C., van de Winkel, J.G.J., Platts-Mills, T.A.E., and Parren, P.W.H.I. (2011) Anti-galactose-a-1, 3-galactose IgE from allergic patients does not bind a-galactosylated glycans on intact therapeutic antibody Fc domains. Nat. Biotechnol., 29, 574-576.
-
(2011)
Nat. Biotechnol.
, vol.29
, pp. 574-576
-
-
van Bueren, J.J.L.1
Rispens, T.2
Verploegen, S.3
van der Palen-Merkus, T.4
Stapel, S.5
Workman, L.J.6
James, H.7
van Berkel, P.H.C.8
van de Winkel, J.G.J.9
Platts-Mills, T.A.E.10
Parren, P.W.H.I.11
-
23
-
-
84884651147
-
-
New compendia procedures for characterization of different classes of biopharmaceutical. Biotherapeutics Analytical Summit March 2012 Baltimore MD.
-
Morris, T. (2012) New compendia procedures for characterization of different classes of biopharmaceutical. Biotherapeutics Analytical Summit, March 2012, Baltimore, MD.
-
(2012)
-
-
Morris, T.1
-
24
-
-
41449103126
-
Separation-based glycoprofi ling approaches using fluorescent labels
-
Domann, P.J., Pardos-Pardos, A.C., Fernandes, D.L., Spencer, D.I., Radcliffe, C.M., Royle, L., Dwek, R.A., and Rudd, P.M. (2007) Separation-based glycoprofi ling approaches using fluorescent labels. Proteomics, 7 (Suppl. 1), 70-76.
-
(2007)
Proteomics
, vol.7
, Issue.1 SUPPL
, pp. 70-76
-
-
Domann, P.J.1
Pardos-Pardos, A.C.2
Fernandes, D.L.3
Spencer, D.I.4
Radcliffe, C.M.5
Royle, L.6
Dwek, R.A.7
Rudd, P.M.8
-
25
-
-
79952478993
-
A QbD approach to biopharmaceutical glycosylation
-
(ed. N. Lyscom) Biopharm Knowledge Old Basing.
-
Fernandes, D.L. (2008) A QbD approach to biopharmaceutical glycosylation, in Quality for Biologics-Critical Quality Attributes, Process and Change Control, Product Variation, Characterisation, and Regulatory Concerns (ed. N. Lyscom), Biopharm Knowledge, Old Basing.
-
(2008)
Quality for Biologics-Critical Quality Attributes Process and Change Control Product Variation Characterisation, and Regulatory Concerns
-
-
Fernandes, D.L.1
-
26
-
-
84884659848
-
-
(eds B.O. Fraser-Reid K. Tatsuta, and J. Thiem) Springer Berlin.
-
Fernandes, D.L. and Spencer, D.I. (2008) Glycoprotein analysis, in Glycoscience-Chemistry and Chemical Biology (eds B.O. Fraser-Reid, K. Tatsuta, and J. Thiem), Springer, Berlin.
-
(2008)
Glycoprotein analysis in Glycoscience-Chemistry and Chemical Biology
-
-
Fernandes, D.L.1
Spencer, D.I.2
-
27
-
-
84884662501
-
-
European Medicines Agency (2005) ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology. EMA Documents CPMP/ICH/381/95. EMEA London.
-
European Medicines Agency (2005) ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology. EMA Documents CPMP/ICH/381/95. EMEA, London.
-
-
-
-
28
-
-
23844433927
-
Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals
-
Butler, M. (2005) Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals. Appl. Microbiol. Biotechnol., 68, 283-291.
-
(2005)
Appl. Microbiol. Biotechnol.
, vol.68
, pp. 283-291
-
-
Butler, M.1
-
29
-
-
84884614873
-
-
Characterization and control of protein glycosylation in cell bioprocesses. CHI Post-Translational Modifi cations Conference San Diego CA.
-
Butler, M. (2010) Characterization and control of protein glycosylation in cell bioprocesses. CHI Post-Translational Modifi cations Conference, San Diego, CA.
-
(2010)
-
-
Butler, M.1
-
30
-
-
70350512964
-
A predictive high-throughput scale-down model of monoclonal antibody production in CHO cells
-
Legmann, R., Schreyer, H.B., Combs, R.G., McCormick, E.L., Russo, A.P., and Rodgers, S.T. (2009) A predictive high-throughput scale-down model of monoclonal antibody production in CHO cells. Biotechnol. Bioeng., 104, 1107-1120.
-
(2009)
Biotechnol. Bioeng.
, vol.104
, pp. 1107-1120
-
-
Legmann, R.1
Schreyer, H.B.2
Combs, R.G.3
McCormick, E.L.4
Russo, A.P.5
Rodgers, S.T.6
-
31
-
-
68749110765
-
Optimal and consistent protein glycosylation in mammalian cell culture
-
Hossler, P., Khattak, S.F., and Li, Z.J. (2009) Optimal and consistent protein glycosylation in mammalian cell culture. Glycobiology, 19, 936-949.
-
(2009)
Glycobiology
, vol.19
, pp. 936-949
-
-
Hossler, P.1
Khattak, S.F.2
Li, Z.J.3
|