-
5
-
-
16844385133
-
-
Chen M et al. Med Res Rev 2005; 25:343-369.
-
(2005)
Med Res Rev
, vol.25
, pp. 343-369
-
-
Chen, M.1
-
9
-
-
0004248246
-
-
,, New York: Marcel Dekker
-
Kopp K, Schlüter M, Werner RG. In: Townsend RR, Hotch-kiss AT Jr, eds. Techniques in Glycobiology. New York: Marcel Dekker, 1997:475-489.
-
(1997)
Techniques in Glycobiology
, pp. 475-489
-
-
Kopp, K.1
Schlüter, M.2
Werner, R.G.3
Townsend, R.R.4
Hotch-Kiss, A.T.5
-
10
-
-
85144118745
-
-
Note for Guidance on Biotechnological/Biological Products Subject to changes in their Manufacturing Process, December
-
Note for Guidance on Biotechnological/Biological Products Subject to changes in their Manufacturing Process. CPMP/ICH/5721/03, CHMP, December 2004.
-
(2004)
CPMP/ICH/5721/03
-
-
-
11
-
-
85144163484
-
CPMP
-
Guideline on Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance—Quality Issues CPMP/BWP/3207/00 Rev.1
-
Guideline on Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance—Quality Issues CPMP/BWP/3207/00 Rev.1, CPMP, December 2003.
-
(2003)
December
-
-
-
12
-
-
85064653741
-
-
Allgaier H. Chimia 1994; 48:464-466.
-
(1994)
Chimia
, vol.48
, pp. 464-466
-
-
Allgaier, H.1
-
16
-
-
85144153705
-
-
. Biotechnology-derived articles. Rockville, MD, Pharmacopeial Convention, Inc
-
The United States Pharmacopeia. Biotechnology-derived articles. Rockville, MD: U.S. Pharmacopeial Convention, Inc., 1994:1849-1859.
-
(1994)
U.S
, pp. 1849-1859
-
-
-
18
-
-
0035836065
-
-
Harris RJ et al. J Chrom B 2001; 752:233-245.
-
(2001)
J Chrom B
, vol.752
, pp. 233-245
-
-
Harris, R.J.1
-
20
-
-
0004248246
-
Werner RG
-
Townsend RR, Hotchkiss AT Jr, eds. New York: Marcel Dekker
-
Kopp K, Schlüter M, Werner RG. In: Techniques in Glycobiology. Townsend RR, Hotchkiss AT Jr, eds. New York: Marcel Dekker, 1997:475-489.
-
(1997)
Techniques in Glycobiology
, pp. 475-489
-
-
Kopp, K.1
Schlüter, M.2
-
22
-
-
0029074080
-
Protein mass spectrometry: Applications to analytical biotechnology
-
Nguyen DN et al. Protein mass spectrometry: applications to analytical biotechnology. J Chromatogr 1995; A705:21-45.
-
(1995)
J Chromatogr
, vol.A705
, pp. 21-45
-
-
Nguyen, D.N.1
-
23
-
-
0033755938
-
Determination of the origin of charge heterogeneity in a murine monoclonal antibody
-
Perkins M et al. Determination of the origin of charge heterogeneity in a murine monoclonal antibody. Pharm Res 2000; 17:1110-1117.
-
(2000)
Pharm Res
, vol.17
, pp. 1110-1117
-
-
Perkins, M.1
-
24
-
-
24344456964
-
Structural characterization of the maytansinoid-monoclonal antibody immunoconjugate, huN901-DM1, by mass spectrometry
-
Wang L et al. Structural characterization of the maytansinoid-monoclonal antibody immunoconjugate, huN901-DM1, by mass spectrometry. Protein Sci 2005; 14:2436-2446.
-
(2005)
Protein Sci
, vol.14
, pp. 2436-2446
-
-
Wang, L.1
-
29
-
-
0040291711
-
-
In: Hugli TE, ed., San Diego: Academic Press
-
Gibson BW, Yu Z, Gillece-Castro B, Aberth W, Walls FC, Burlingame AL. In: Hugli TE, ed. Techniques in Protein Chemistry. Vol. 3. San Diego: Academic Press, 1989:135-151.
-
(1989)
Techniques in Protein Chemistry
, vol.3
, pp. 135-151
-
-
Gibson, B.W.1
Yu, Z.2
Gillece-Castro, B.3
Aberth, W.4
Walls, F.C.5
Burlingame, A.L.6
-
37
-
-
84910560463
-
O’Connor JV
-
Rockville, MD: U.S. Pharmacopeia
-
Jones AJS, O’Connor JV. In: Gueriguian JL, Bransome ED Jr, Outschoorn AS, eds. Hormone Drugs. Rockville, MD: U.S. Pharmacopeia, 1982:335-351.
-
(1982)
Hormone Drugs
, pp. 335-351
-
-
Jones, A.J.S.1
Gueriguian, J.L.2
Bransome, E.D.3
Outschoorn, A.S.4
-
43
-
-
0035887070
-
Fourier transform infrared spectrometric analysis of protein conformation: Effect of sampling method and stress factors
-
Van der Weert M et al. Fourier transform infrared spectrometric analysis of protein conformation: effect of sampling method and stress factors. Anal Biochem 2001; 297:160-169.
-
(2001)
Anal Biochem
, vol.297
, pp. 160-169
-
-
van der Weert, M.1
-
44
-
-
67650591341
-
Differential scanning calorimetry: A practical tool for elucidating stability in liquid pharmaceuticals
-
Remmele RL Jr et al. Differential scanning calorimetry: a practical tool for elucidating stability in liquid pharmaceuticals. Biopharm Eur 2000; 56:58-60.
-
(2000)
Biopharm Eur
, vol.56
, pp. 58-60
-
-
Remmele, R.L.1
-
45
-
-
84981611610
-
The fluorescence of native, denatured, and reduced-denatured proteins. Photocem
-
Kronman MJ, Holmes L.G. The fluorescence of native, denatured, and reduced-denatured proteins. Photocem. Photobiol 1971; 14:113-134.
-
(1971)
Photobiol
, vol.14
, pp. 113-134
-
-
Kronman, M.J.1
Holmes, L.G.2
-
49
-
-
0025214337
-
-
Tsuda E, Kawanishi G, Ueda M, Masuda S, Sasaki R. Eur J Biochem 1990; 188:405-411.
-
(1990)
Eur J Biochem
, vol.188
, pp. 405-411
-
-
Tsuda, E.1
Kawanishi, G.2
Ueda, M.3
Masuda, S.4
Sasaki, R.5
-
56
-
-
0032055988
-
Effect of C2-associated carbohydrate structure on IgG effector function: Studies with chimeric mouse-human iGG1 antibodies in glycosyl-ation mutants of Chinese hamster ovary cells
-
Wright A, Morrison SL. Effect of C2-associated carbohydrate structure on IgG effector function: studies with chimeric mouse-human iGG1 antibodies in glycosyl-ation mutants of Chinese hamster ovary cells. J Immunol 1998; 160:3393-3402.
-
(1998)
J Immunol
, vol.160
, pp. 3393-3402
-
-
Wright, A.1
Morrison, S.L.2
-
57
-
-
0037178791
-
Lack of fucose on human IgG1 N-Linked oligosaccharide improves binding to human FcgRIII and antibody-dependent cellular toxicity
-
Shields RL et al. Lack of fucose on human IgG1 N-Linked oligosaccharide improves binding to human FcgRIII and antibody-dependent cellular toxicity. J Biol Chem 2002; 277:26733-26740.
-
(2002)
J Biol Chem
, vol.277
, pp. 26733-26740
-
-
Shields, R.L.1
-
58
-
-
0034802701
-
Glycosylation of human IgG antibodies: Relevance to therapeutic applications
-
Jefferis R. Glycosylation of human IgG antibodies: relevance to therapeutic applications. Biopharm 2001; 14:19-26.
-
(2001)
Biopharm
, vol.14
, pp. 19-26
-
-
Jefferis, R.1
-
60
-
-
0025840338
-
-
Goochee CF, Gramer MJ, Anderson DC, Bahr JB, Rasmussen JR. Biotechnology 1991; 9:1347-1355.
-
(1991)
Biotechnology
, vol.9
, pp. 1347-1355
-
-
Goochee, C.F.1
Gramer, M.J.2
Anderson, D.C.3
Bahr, J.B.4
Rasmussen, J.R.5
-
68
-
-
0036462597
-
Structural investigations of glycoconjugates at high sensitivity
-
Mechref Y, Novotny MV. Structural investigations of glycoconjugates at high sensitivity. Chem Rev 2002; 102:321-369.
-
(2002)
Chem Rev
, vol.102
, pp. 321-369
-
-
Mechref, Y.1
Novotny, M.V.2
-
69
-
-
0031553988
-
Characterization of monoclonal antibody glycosylation: Comparison of expression systems and identification of terminal a-linked galactose
-
Sheeley DM et al. Characterization of monoclonal antibody glycosylation: comparison of expression systems and identification of terminal a-linked galactose. Anal Biochem 1997; 247:102-110.
-
(1997)
Anal Biochem
, vol.247
, pp. 102-110
-
-
Sheeley, D.M.1
-
73
-
-
5844389342
-
-
eds. Pharmaceutical Dosage Forms: Parenteral Medications. New York: Marcel Dekker
-
Wang YJ. In: Avis KE, Lieberman HA, Lachman L, eds. Pharmaceutical Dosage Forms: Parenteral Medications. New York: Marcel Dekker, 1992:283-319.
-
(1992)
Avis KE, Lieberman HA, Lachman L
, pp. 283-319
-
-
Wang, Y.J.1
-
80
-
-
0001922433
-
-
ed. Protein Structure: A Practical Approach. Oxford: IRL Press
-
Righetti PG. In: Creighton TE, ed. Protein Structure: A Practical Approach. Oxford: IRL Press, 1989:23-63.
-
(1989)
Creighton TE
, pp. 23-63
-
-
Righetti, P.G.1
-
84
-
-
84913154972
-
-
Canova-Davis E, Teshima GM, Kessler TJ, Lee PJ, Guzzetta AW, Hancock WS. Am Chem Soc Symp 1990; 434:90-112.
-
(1990)
Am Chem Soc Symp
, vol.434
, pp. 90-112
-
-
Canova-Davis, E.1
Teshima, G.M.2
Kessler, T.J.3
Lee, P.J.4
Guzzetta, A.W.5
Hancock, W.S.6
-
85
-
-
84912853645
-
-
, eds., Plainview, NY: Cold Spring Harbor Laboratory
-
Pearlman R, Nguyen TH. In: Marshak D, Liu D, eds. Therapeutic Peptides and Proteins: Formulation, Delivery, and Targeting. Plainview, NY: Cold Spring Harbor Laboratory, 1989:23-30.
-
(1989)
Therapeutic Peptides and Proteins: Formulation, Delivery, and Targeting
, pp. 23-30
-
-
Pearlman, R.1
Nguyen, T.H.2
Marshak, D.3
Liu, D.4
-
86
-
-
85144096106
-
-
Capillary electrophoresis of proteins in a quality control environment. Capillary Electrophoresis of Proteins and Peptides, New Jersey: Human Press Inc
-
Good DL. Capillary electrophoresis of proteins in a quality control environment. Capillary Electrophoresis of Proteins and Peptides, Methods in Molecular Biology. New Jersey: Human Press Inc, 2004:276.
-
(2004)
Methods in Molecular Biology
, pp. 276
-
-
Good, D.L.1
-
87
-
-
0003864375
-
-
Marcel Dekker, Inc
-
Wehr T, Rodriguez-Diaz R, Zhu M. Capillary Electrophoresis of Proteins, Chroatography Science Series. New York: Marcel Dekker, Inc., 1999:80.
-
(1999)
Capillary Electrophoresis of Proteins, Chroatography Science Series. New York
, pp. 80
-
-
Wehr, T.1
Rodriguez-Diaz, R.2
Zhu, M.3
-
88
-
-
84913193656
-
-
ed. HPLC of Macromolecules: A Practical Approach. Oxford: IRL Press
-
Henry MP. In: Oliver RWA, ed. HPLC of Macromolecules: A Practical Approach. Oxford: IRL Press, 1989:9-125.
-
(1989)
, pp. 9-125
-
-
Henry, M.P.1
Oliver, R.W.A.2
-
92
-
-
0002964990
-
-
ed. Protein Structure: A Practical Approach, Oxford: IRL Press
-
See YP, Jackowski G. In: Creighton TE, ed. Protein Structure: A Practical Approach, Oxford: IRL Press, 1989:1-21.
-
(1989)
Creighton TE
, pp. 1-21
-
-
See, Y.P.1
Jackowski, G.2
-
97
-
-
85144156298
-
-
eds. Gel Electrophoresis of Proteins: A Practical Approach. Oxford: IRL Press
-
Harnes BD. In: Harnes BD, Rickwood D, eds. Gel Electrophoresis of Proteins: A Practical Approach. Oxford: IRL Press, 1981:1-91.
-
(1981)
, pp. 1-91
-
-
Harnes, B.D.1
Harnes, B.D.2
Rickwood, D.3
-
99
-
-
0014711889
-
Methods Biochem
-
Andrews P. Methods Biochem. Anal 1970; 18:1-53.
-
(1970)
Anal
, vol.18
, pp. 1-53
-
-
Andrews, P.1
-
100
-
-
33947484782
-
Determination of molecular weights of proteins bygel
-
Whitaker R, Determination of molecular weights of proteins bygel. Anal Chera, 1963 35:1950-53.
-
(1963)
Anal Chera
, vol.35
, pp. 1950-1953
-
-
Whitaker, R.1
-
101
-
-
0025924326
-
-
Van Liedekerke BM, Nelis HJ, Kint JA, Vanneste FW, De Leenheer AP. J Pharm Sci 1991; 80:11-16.
-
(1991)
J Pharm Sci
, vol.80
, pp. 11-16
-
-
van Liedekerke, B.M.1
Nelis, H.J.2
Kint, J.A.3
Vanneste, F.W.4
de Leenheer, A.P.5
-
103
-
-
0039926756
-
-
Smith RD, Loo JA, Loo RRO, Busman M, Udseth HR. Mass Spectrom Rev 1991; 10:359-451.
-
(1991)
Mass Spectrom Rev
, vol.10
, pp. 359-451
-
-
Smith, R.D.1
Loo, J.A.2
Loo, R.R.O.3
Busman, M.4
Udseth, H.R.5
-
111
-
-
0019862595
-
-
Gery I, Davies P, Derr J, Krett N, Barranger JA. Cell Immunol 1981; 64:293-303.
-
(1981)
Cell Immunol
, vol.64
, pp. 293-303
-
-
Gery, I.1
Davies, P.2
Derr, J.3
Krett, N.4
Barranger, J.A.5
-
112
-
-
0027861175
-
Pharmaceutical biotechnology
-
In:, eds., New York: Plenum Press
-
Gu L, Fausnaugh J. Pharmaceutical biotechnology. In: Wang YJ, Pearlman R, eds. Stability and Characterization of Proteins and Peptid Drugs: Case Histories. Vol. 5. New York: Plenum Press, 1993:221-248.
-
(1993)
Stability and Characterization of Proteins and Peptid Drugs: Case Histories
, vol.5
, pp. 221-248
-
-
Gu, L.1
Fausnaugh, J.2
Wang, Y.J.3
Pearlman, R.4
-
114
-
-
84965404879
-
Interferon assays and standards
-
In: Finger NB, ed., Amsterdam: North Holland
-
Finter NB. Interferon assays and standards. In: Finger NB, ed. Interferons. Amsterdam: North Holland, 1966:87.
-
(1966)
Interferons
, pp. 87
-
-
Finter, N.B.1
-
120
-
-
0025996758
-
-
Werner RG, Bassarab S, Hoffman H, Schlüter M. Arzneim Forsch/Drug Res 1991; 41(11):1196-1200.
-
(1991)
Arzneim Forsch/Drug Res
, vol.41
, Issue.11
, pp. 1196-1200
-
-
Werner, R.G.1
Bassarab, S.2
Hoffman, H.3
Schlüter, M.4
-
122
-
-
85144110644
-
-
WHO Epidemiological Records. 1997; 72(20):143-145.
-
(1997)
, vol.72
, Issue.20
, pp. 143-145
-
-
-
123
-
-
77957084415
-
-
Schiff LJ, Moore WA, Brown J, Wisher H. BioPharm 1992; 5(5):36-39.
-
(1992)
Biopharm
, vol.5
, Issue.5
, pp. 36-39
-
-
Schiff, L.J.1
Moore, W.A.2
Brown, J.3
Wisher, H.4
-
126
-
-
85144129723
-
Mammalian Cell Biotechnology in Protein Production. Berlin
-
Walter J, Allgaier H. In: Hauser H, Wagner R, eds. Mammalian Cell Biotechnology in Protein Production. Berlin, New York: Walter de Gruyter, 1997; 451(1)-483.
-
(1997)
New York: Walter De Gruyter
, vol.451
, Issue.1
, pp. 483
-
-
Walter, J.1
Allgaier, H.2
Hauser, H.3
Wagner, R.4
-
127
-
-
85144105415
-
-
Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
-
CPMP/ICH/295/95. Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, 1997.
-
(1997)
-
-
-
128
-
-
85144147218
-
-
Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
-
CPMP/ICH/294/95. Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, 1998.
-
(1998)
-
-
-
129
-
-
0006090244
-
-
eds. Formulation and Delivery of Proteins and Peptides. Washington, DC: American Chemical Society
-
Jones AJS. In: Cleland JL, Langer R, eds. Formulation and Delivery of Proteins and Peptides. Washington, DC: American Chemical Society, 1994:22-45.
-
(1994)
, pp. 22-45
-
-
Jones, A.J.S.1
Cleland, J.L.2
Langer, R.3
-
134
-
-
0028341681
-
-
Vermuri S, Beylin I, Sluzky V, Stratton P, Eberlein G, Wang YJ. J Pharm Pharmacol 1994; 46:481-486.
-
(1994)
J Pharm Pharmacol
, vol.46
, pp. 481-486
-
-
Vermuri, S.1
Beylin, I.2
Sluzky, V.3
Stratton, P.4
Eberlein, G.5
Wang, Y.J.6
-
137
-
-
0014995599
-
Correction of light-scattering errors in spectro-photometric protein determinations
-
Winder AF, Gent WLG. Correction of light-scattering errors in spectro-photometric protein determinations. Biopoly 1971; 10:1243-51.
-
(1971)
Biopoly
, vol.10
, pp. 1243-1251
-
-
Winder, A.F.1
Gent, W.L.G.2
-
138
-
-
85144120794
-
Particle Size Analysis in Pharmaceutics and Other Industries: Theory and Practice
-
Washington C. Particle Size Analysis in Pharmaceutics and Other Industries: Theory and Practice. New York: Ellis Horwood 1992:Chap. 7.
-
New York: Ellis Horwood 1992:Chap. 7
-
-
Washington, C.1
-
149
-
-
0002480007
-
-
eds. Formulation and Delivery of Proteins and Peptides. Washington, DC: American Chemical Society
-
Powell MF. In: Cleland JL, Langer R, eds. Formulation and Delivery of Proteins and Peptides. Washington, DC: American Chemical Society, 1994:100-117.
-
(1994)
, pp. 100-117
-
-
Powell, M.F.1
Cleland, J.L.2
Langer, R.3
-
151
-
-
85144133245
-
-
Target and Methodology, CPMP/ICH/381/95-1CHQ2 (Res)
-
ICH Guidance Validation of Analytical Procedures. Target and Methodology, CPMP/ICH/381/95-1CHQ2 (Res).
-
-
-
-
152
-
-
85144115936
-
-
USA. Stuttgart: Wissenschaftliche Verlag
-
Hoffmann H, Bassarab S, Schlüter M, Werz W, Werner RG. Stability testing of biopharmaceuticals. Paperback APV, Band 32, Stability Testing in the EC, Japan and the USA. Stuttgart: Wissenschaftliche Verlag, 1993:245-272.
-
(1993)
Stability Testing of Biopharmaceuticals. Paperback APV, Band 32, Stability Testing in the EC, Japan and The
, pp. 245-272
-
-
Hoffmann, H.1
Bassarab, S.2
Schlüter, M.3
Werz, W.4
Werner, R.G.5
-
153
-
-
85144120553
-
-
CPMP/ICH/2736/99. Aug. 2003
-
International Conference on Harmonization. www.emea.europa.eu/htms/human/ich/ichquality.htm. CPMP/ICH/2736/99. Aug. 2003.
-
-
-
-
154
-
-
85144099125
-
Quality of biotechnological products: Stability testing of biotechnological/biological products (Topic Q5C)
-
July
-
International Conference on Harmonization. Quality of biotechnological products: stability testing of biotechnological/biological products (Topic Q5C). CPMP/ ICH/138/95. July 1996.
-
(1996)
CPMP/ ICH/138/95
-
-
|